Installation and removal of an intrauterine contraceptive device. Intrauterine devices Monitoring the IUD code according to the ICD
- N93 Other abnormal bleeding from the uterus and vagina
- N95.1 Menopausal and menopausal conditions in women
- Z30.0 General Tips and consultations on contraception
Composition and release form
in vacuum paper-plastic packaging 1 pc.; 1 package in a box.
Description of the dosage form
An intrauterine therapy system (IUD) is placed in a guide tube. The system consists of a white or off-white hormone-elastomer core placed on a T-shaped body and covered with an opaque membrane that regulates the release of levonorgestrel. The T-shaped body has a loop at one end and two arms at the other. Threads are attached to the loop to remove the system. The system and conductor are free of visible impurities.
pharmachologic effect
Pharmacological action: contraceptive, gestagenic.Pharmacokinetics
Absorption. Once inserted into the uterus, Mirena begins to immediately release levonorgestrel.
The high local exposure of the drug in the uterine cavity, necessary for the local effect of Mirena on the endometrium, provides a high concentration gradient in the direction from the endometrium to the myometrium (the concentration of levonorgestrel in the endometrium exceeds its concentration in the myometrium by more than 100 times) and low concentrations of levonorgestrel in the blood serum ( the concentration of levonorgestrel in the endometrium exceeds its concentration in the blood serum by more than 1000 times).
The rate of release of levonorgestrel into the uterine cavity in vivo is initially approximately 20 mcg/day, and after 5 years it decreases to 10 mcg/day.
Distribution. Levonorgestrel binds nonspecifically to serum albumin and specifically to sex hormone binding globulin (SHBG). About 1-2% of circulating levonorgestrel is present as the free steroid, while 42-62% is specifically bound to SHBG. During the use of Mirena, the concentration of SHBG decreases. Accordingly, the fraction associated with SHBG decreases during the period of Mirena use, and the free fraction increases. The average apparent Vd of levonorgestrel is 106 L.
After Mirena is administered, levonorgestrel is detected in the blood serum an hour later. Cmax is achieved 2 weeks after Mirena administration. Consistent with the decreasing release rate, the median serum concentration of levonorgestrel in women of reproductive age weighing more than 55 kg decreases from 206 pg/ml (25-75th percentile: 151-264 pg/ml), determined after 6 months, to 194 pg/ml (146-266 pg/ml) - after 12 months and up to 131 pg/ml (113-161 pg/ml) - after 60 months.
Body weight and serum SHBG concentrations have been shown to influence systemic levonogestrel concentrations, i.e. with low body weight and/or high SHBG levels, the concentration of levonorgestrel is higher. In women of reproductive age with low body weight (37-55 kg), the median serum concentration of levonorgestrel is approximately 1.5 times higher.
In postmenopausal women using Mirena in combination with non-oral estrogen therapy, the median serum levonorgestrel concentration decreased from 257 pg/ml (25-75th percentile: 186-326 pg/ml) determined at 12 months to 149 (122 -180 pg/ml) - after 60 months. When Mirena is used simultaneously with oral estrogen therapy, the concentration of levonorgestrel in the blood serum, determined after 12 months, increases to approximately 478 pg / ml (25-75th percentile: 341-655 pg / ml), which is due to the induction of SHBG synthesis by mouth estrogens.
Biotransformation. Levonorgestrel is extensively metabolized. The main metabolites in blood plasma are unconjugated and conjugated forms of 3α, 5β-tetrahydrolevonogestrel. Based on the results of in vitro and in vivo studies, the main isoenzyme involved in the metabolism of levonorgestrel is CYP3A4. The isoenzymes CYP2E1, CYP2C19 and CYP2C9 may be involved in the metabolism of levonorgestrel, but to a lesser extent.
Elimination. The total plasma clearance of levonorgestrel is approximately 1 ml/min/kg. Unchanged levonorgestrel is excreted only in trace amounts. Metabolites are excreted through the intestines and kidneys with an excretion coefficient of approximately 1.77. T1/2 in the terminal phase, represented mainly by metabolites, is about a day.
Pharmacodynamics
Mirena is an intrauterine system (IUD) that releases levonorgestrel and has a primarily local gestagenic effect. Progestin (levonorgestrel) is released directly into the uterine cavity, which allows it to be used in an extremely low daily dose. High concentrations of levonorgestrel in the endometrium help to reduce the sensitivity of its estrogen and progesterone receptors, making the endometrium resistant to estradiol and having a strong antiproliferative effect. When using Mirena, morphological changes in the endometrium and a weak local reaction to the presence in the uterus are observed foreign body. Thickening of the mucous membrane of the cervical canal prevents the penetration of sperm into the uterus, Mirena prevents fertilization due to inhibition of the motility and function of sperm in the uterus and fallopian tubes. In some women, ovulation is also suppressed.
Previous use of Mirena does not affect reproductive function. Approximately 80% of women who want to have a child become pregnant within 12 months after removal of the IUD.
In the first months of using Mirena, due to inhibition of the process of endometrial proliferation, an initial increase in spotting may be observed. Following this, pronounced suppression of the endometrium leads to a decrease in the duration and volume of menstrual bleeding in women using Mirena. Scanty bleeding often transforms into oligo- or amenorrhea. At the same time, ovarian function and the concentration of estradiol in the blood remain normal. Mirena can be used to treat idiopathic menorrhagia, i.e. menorrhagia in the absence of genital diseases (for example, endometrial cancer, metastatic lesions of the uterus, submucosal or large interstitial node of uterine fibroids, leading to deformation of the uterine cavity, adenomyosis, endometrial hyperplastic processes, endometritis) and extragenital diseases and conditions accompanied by severe hypocoagulation (for example, von Willebrand, severe thrombocytopenia), the symptoms of which are menorrhagia. By the end of the third month after installation of the Mirena, in women suffering from menorrhagia, the volume of menstrual bleeding decreased by 88%. For menorrhagia caused by submucosal fibroids, the effect of treatment is less pronounced. Reducing menstrual blood loss reduces the risk iron deficiency anemia. Mirena also reduces the severity of dysmenorrhea.
The effectiveness of Mirena in preventing endometrial hyperplasia during chronic estrogen therapy was equally high with both oral and transdermal estrogen use.
Indications
contraception;
idiopathic menorrhagia;
prevention of endometrial hyperplasia during estrogen replacement therapy.
Contraindications
hypersensitivity to the components of the drug;
pregnancy or suspicion of it;
existing or recurrent inflammatory diseases of the pelvic organs;
infections of the lower genitourinary tract;
postpartum endometritis;
septic abortion within the last 3 months;
cervicitis;
diseases accompanied by increased susceptibility to infections;
cervical dysplasia;
malignant neoplasms of the uterus or cervix;
progestogen-dependent tumors, incl. mammary cancer;
pathological uterine bleeding of unknown etiology;
congenital or acquired anomalies of the uterus, incl. fibroids leading to deformation of the uterine cavity;
acute liver diseases or tumors.
CAREFULLY
After consultation with a specialist:
migraine, focal migraine with asymmetric vision loss or other symptoms indicating transient cerebral ischemia;
unusually severe headache;
severe arterial hypertension;
severe circulatory disorders, incl. stroke and myocardial infarction.
The advisability of removing the system should be discussed if any of the following conditions are present or first occur.
Use during pregnancy and breastfeeding
Pregnancy. Mirena should not be used if you are pregnant or suspected of being pregnant. If a woman becomes pregnant while using Mirena, it is recommended to remove the IUD, because Any intrauterine contraceptive device left in situ increases the risk of spontaneous abortion and premature birth. Removing Mirena or probing the uterus may lead to spontaneous abortion. If it is not possible to carefully remove the intrauterine contraceptive device, the advisability of induced termination of pregnancy should be discussed. If a woman wants to continue her pregnancy and the IUD cannot be removed, the patient should be informed about the risks and possible consequences premature birth for the baby. In such cases, the course of pregnancy should be carefully monitored. Must be excluded ectopic pregnancy. The woman should be advised that she should report any symptoms that suggest a pregnancy complication, particularly colicky abdominal pain accompanied by fever.
Due to the intrauterine use and local action of the hormone, it is necessary to take into account the possibility of a virilizing effect on the fetus. Due to the high contraceptive effectiveness of Mirena, clinical experience regarding pregnancy outcomes with its use is limited. However, the woman should be advised that there is currently no evidence of birth defects caused by the use of Mirena in cases of pregnancy continuing until childbirth without removal of the IUD.
Lactation. About 0.1% of the levonorgestrel dose may enter the newborn's body during breastfeeding. However, it is unlikely to pose a risk to the baby at doses released by Mirena in the uterus.
It is believed that the use of Mirena 6 weeks after birth does not have a harmful effect on the growth and development of the child. Monotherapy with gestagens has no effect on quantity and quality breast milk. Rare cases of uterine bleeding have been reported in women using Mirena during lactation.
Side effects
Side effects most often develop in the first months after Mirena is inserted into the uterus; with prolonged use they gradually disappear.
Very common side effects (seen in more than 10% of women using Mirena) include uterine/vaginal bleeding, spotting bloody issues, oligo- and amenorrhea, benign ovarian cysts. The average number of days of spotting in women of childbearing age gradually decreases from nine to four days per month during the first six months after IUD insertion. The number of women with prolonged (more than eight days) bleeding decreases from 20 to 3% in the first 3 months of using Mirena. IN clinical studies It was found that in the first year of Mirena use, 17% of women experienced amenorrhea lasting at least 3 months. When Mirena is used in combination with estrogen replacement therapy, most peri- and postmenopausal women experience spotting and irregular bleeding in the first months of treatment. Subsequently, their frequency decreases, and in approximately 40% of women receiving this therapy, bleeding completely disappears in the last 3 months of the first year of treatment. Changes in bleeding patterns are more common in the perimenopausal period than in the postmenopausal period. The frequency of detection of benign ovarian cysts depends on the diagnostic method used. According to clinical trials, enlarged follicles were diagnosed in 12% of women who used Mirena. In most cases, the enlargement of follicles was asymptomatic and disappeared within 3 months. The table shows side effects, classified by organs and systems according to MedDRA. The frequency corresponds to data from clinical studies.
| Organ and system | Frequency of side effects | ||
| Often - ≥1/100,<1/10 | Rarely - ≥1/1000,<1/100 | Very rare - ≥1/10000,<1/1000 | |
| Mental disorders | Depressed mood, nervousness, decreased libido | Mood changes | |
| Nervous system disorders | Headache | Migraine | |
| Gastrointestinal disorders | Abdominal pain, nausea | Bloating | |
| Skin and subcutaneous tissue disorders | Acne | Alopecia, rash, hirsutism, itching, eczema | Rash, hives |
| Musculoskeletal disorders | Backache | ||
| Disorders of the reproductive system and mammary glands | Pelvic pain, dysmenorrhea, vaginal discharge, vulvovaginitis, breast tenderness, breast tenderness | Pelvic inflammatory disease, endometritis, cervicitis/Pap smear result corresponds to class II | Perforation of the uterus |
| Metabolic disorders | Weight gain | ||
| From the body as a whole | Edema | ||
| General disorders and pathological conditions in the area of Mirena installation | Expulsion IUD |
See also “Use with caution” and “Special instructions”.
Terminology consistent with MedDRA is used in most cases to describe certain reactions, their synonyms and associated conditions.
If a woman with Mirena installed becomes pregnant, the relative risk of ectopic pregnancy increases. In addition, cases of breast cancer have been reported (frequency unknown).
Interaction
The metabolism of gestagens may be enhanced by the simultaneous use of substances that are enzyme inducers, especially cytochrome P450 isoenzymes involved in the metabolism of drugs, such as anticonvulsants (for example, phenobarbital, phenytoin, carbamazepine) and drugs for the treatment of infections (for example, rifampicin, rifabutin, nevirapine, efavirenz ). The effect of these drugs on the effectiveness of Mirena is not known, but it is believed that it is not significant since Mirena has mainly local effects.
Overdose
Not noted.
Directions for use and doses
Intrauterine. Mirena is inserted into the uterine cavity and remains effective for five years. The in vivo release rate of levonorgestrel is approximately 20 mcg/day initially and decreases after five years to approximately 10 mcg/day. The average release rate of levonorgestrel is approximately 14 mcg/day for up to 5 years. Mirena can be used in women receiving hormone replacement therapy in combination with oral or transdermal estrogen preparations that do not contain progestogens.
With correct installation of Mirena, carried out in accordance with the instructions for medical use, the Pearl index (an indicator reflecting the number of pregnancies in 100 women using a contraceptive during the year) is approximately 0.2% within 1 year. The cumulative rate, reflecting the number of pregnancies in 100 women using contraception for 5 years, is 0.7%.
Instructions for using and handling the IUD
Mirena is supplied in sterile packaging, which is opened only immediately before installation of the intrauterine system. It is necessary to observe aseptic rules when handling an opened system. If the sterility of the packaging appears to be compromised, the IUD should be disposed of as medical waste. The IUD removed from the uterus should also be handled as it contains hormone residues.
Installation, removal and replacement of the intrauterine system
Mirena should only be inserted by a doctor who has experience with this IUD or is well trained in this procedure.
Before inserting Mirena, a woman should be informed about the effectiveness, risks and side effects of this IUD. It is necessary to conduct a general and gynecological examination, including examination of the pelvic organs and mammary glands, as well as a smear examination from the cervix. Pregnancy and sexually transmitted diseases should be excluded, and genital infections should be completely cured. The position of the uterus and the size of its cavity are determined. The correct location of Mirena in the fundus of the uterus is especially important, which ensures a uniform effect of the gestagen on the endometrium, prevents expulsion of the IUD and creates conditions for its maximum effectiveness. Therefore, you should carefully follow the instructions for installing Mirena. Since the technique for installing different IUDs in the uterus is different, special attention should be paid to practicing the correct technique for installing a specific system.
The woman should be re-examined 4-12 weeks after installation, and then once a year or more often, if clinically indicated.
In women of childbearing age, Mirena should be inserted into the uterine cavity within seven days from the start of menstruation. Mirena can be replaced with a new IUD on any day of the menstrual cycle. An IUD can also be inserted immediately after an abortion in the first trimester of pregnancy.
Postpartum IUD insertion should be performed when uterine involution occurs, but not earlier than 6 weeks after birth. With prolonged subinvolution, it is necessary to exclude postpartum endometritis and postpone the decision on the introduction of Mirena until the completion of involution. If there is difficulty inserting the IUD and/or very severe pain or bleeding during or after the procedure, immediate physical and ultrasound examinations should be performed to rule out perforation.
To protect the endometrium during estrogen replacement therapy in women with amenorrhea, Mirena can be installed at any time; in women with continued menstruation, installation is performed in the last days of menstrual bleeding or withdrawal bleeding.
Mirena should not be used for postcoital contraception.
Before installing Mirena, pathological processes in the endometrium should be excluded, since irregular bleeding/spotting is often observed in the first months of its use. Pathological processes in the endometrium should also be excluded if bleeding occurs after the start of estrogen replacement therapy in a woman who continues to use Mirena, previously prescribed for contraception. Appropriate diagnostic measures must also be taken when irregular bleeding develops during long-term treatment.
Mirena is removed by carefully pulling the threads grasped with forceps. If the threads are not visible and the system is in the uterine cavity, it can be removed using a traction hook to remove the IUD. This may require dilation of the cervical canal.
The system should be removed 5 years after installation. If a woman wants to continue using the same method, a new system can be installed immediately after removing the previous one.
If further contraception is necessary in women of childbearing potential, removal of the IUD should be performed during menstruation, provided that the menstrual cycle is maintained. If the system is removed mid-cycle and the woman has had intercourse during the previous week, she is at risk of becoming pregnant unless a new system is installed immediately after the old one is removed.
Installation and removal of the IUD may be accompanied by some pain and bleeding. The procedure may cause fainting due to a vasovagal reaction or a seizure in patients with epilepsy.
Instructions for introduction
Mirena can only be installed by a doctor.
Mirena comes in sterile packaging. Sterilized with ethylene oxide. Do not unpack to avoid compromising sterility. Intended for single use only. Do not use Mirena if the inner packaging is damaged or opened. Must be used by date indicated. With the help of a guide, Mirena (Fig. 1) is inserted into the uterine cavity within 7 days from the start of menstruation or immediately after medical termination of pregnancy, carefully following the attached instructions. Mirena can be replaced with a new IUD on any day of the menstrual cycle.
Figure 1. Appearance and structure of Mirena.
Preparing for the introduction
1. Conduct a gynecological examination to determine the size and position of the uterus and exclude acute cervicitis, pregnancy or other gynecological contraindications.
2. Visualize the cervix using speculum and completely clean the cervix and vagina with a suitable antiseptic solution.
3. If necessary, use the help of an assistant.
4. Grasp the upper lip of the cervix with forceps. Using gentle traction with forceps, straighten the cervical canal. The forceps should be in this position throughout the entire insertion of Mirena to ensure gentle traction of the cervix towards the inserted instrument.
5. Carefully moving the uterine probe through the cavity to the fundus of the uterus, determine the direction of the cervical canal and the depth of the uterine cavity (the distance from the external os to the fundus of the uterus), exclude septa in the uterine cavity, synechiae and submucosal fibroma. If the cervical canal is too narrow, it is recommended to widen the canal and possibly use painkillers/paracervical blockade.
Introduction
1. Open the sterile package (Fig. 2a). After this, all manipulations should be carried out only with sterile gloves.
Figure 2a. Opening the sterile package.
2. Take the handle and rotate the conductor tube so that the divisions of the centimeter scale marked on the tube are located in an ascending direction.
3. Release the threads.
4. Make sure that the slider is in the position most distant from the one performing the procedure (closer to the cervical end).
5. Check that the hangers of the system are in a horizontal position (in the shape of the letter “T”). If this is not the case, they should be leveled on a sterile surface (Fig. 2b).
Figure 2b. Alignment of system hangers.
6. Keeping the slider at the most distant position, use threads (Fig. 3a) to pull the system into the conductor tube.
Figure 3a. Retracting the system into the conductor tube.
7. Make sure that the thickened tips of the shoulders cover the open end of the conductor tube (Fig. 3b). If this does not happen, make sure that the hangers are horizontal by pulling the slider back to the mark (Fig. 7b).
Figure 3b. Correct position of the thickened tips of the hangers.
8. Align the loose hangers on a sterile surface as shown in Figure 2b.
9. Return the slider to its furthest position and hold it firmly with your index finger or thumb.
10. Securely fix the threads in the slot at the near end of the handle of the conductor tube (Fig. 4).
Figure 4. Fixing the threads in the slot of the conductor tube.
11. Set the index ring in accordance with the distance measured by the probe from the external pharynx to the fundus of the uterus, as shown in Fig. 5.
Figure 5. Installing the index ring.
12. Mirena is prepared for insertion. The slider should be held firmly with the index finger or thumb in the most distant position. The guidewire must be carefully advanced through the cervical canal into the uterus until the index ring is 1.5-2 cm from the cervix to leave enough space for the shoulders to open (Fig. 6). The conductor should not be pushed forward with force. If necessary, the cervical canal should be expanded.
Figure 6. Correct placement of the index ring.
13. Holding the conductor motionless, release the horizontal shoulders of the Mirena (Fig. 7a) by pulling the slider towards you to the mark (Fig. 7b). Wait 5-10 seconds for the horizontal shoulders to open.
Figure 7a, 7b. Method of releasing horizontal hangers.
14. Move the guidewire carefully inward until the index ring comes into contact with the cervix. Mirena should now be in the fundal position (Fig. 8).
Figure 8. Mirena fundus position.
15. Release the system completely from the tube: to do this, holding the conductor motionless, pull the slider towards you until it stops. The threads should release automatically (Fig. 9). Before removing the conductor tube, you must make sure that the threads are free.
Figure 9. Release of threads.
16. Remove the guidewire from the uterus. Cut the threads so that their length is 2 cm from the external os of the uterus (Fig. 10).
Figure 10. Removing the guidewire from the uterus.
If there is doubt that the system is installed correctly, you should check the position of Mirena using ultrasound or, if necessary, remove the system and insert a new, sterile one. If the system is not completely in the uterine cavity, it should be removed. The removed system should not be reused.
Removing Mirena. Mirena is removed by carefully pulling the threads grasped with forceps.
Special instructions
If further contraception is necessary in women of childbearing age, the system should be removed during menstruation, subject to a monthly menstrual cycle. Otherwise, at least 7 days before removal. You should use other methods of contraception (for example, a condom).
If a woman is amenorrheic, she should start using barrier contraception 7 days before removal of the system and continue until menstruation returns.
A new Mirena can also be introduced immediately after the old one is removed, in which case there is no need for additional contraception.
After removing Mirena, the system should be checked for integrity. When it was difficult to remove the IUD, there were isolated cases of the hormonal-elastomer core slipping onto the horizontal arms of the T-shaped body, as a result of which they were hidden inside the core. Once the integrity of the IUD is confirmed, this situation does not require additional intervention. Stoppers on the horizontal arms usually prevent the core from completely separating from the T-body.
special instructions
The results of some recent studies indicate that women taking progestogen-only contraceptives may have a slight increase in the risk of venous thrombosis; however, these results are not statistically significant. However, if symptoms of venous thrombosis appear, appropriate diagnostic and treatment measures should be taken immediately.
It has not yet been established whether there is a connection between varicose veins or superficial thrombophlebitis with the phenomenon of venous thromboembolism. Mirena should be used with caution in women with congenital or acquired valvular heart disease, keeping in mind the risk of septic endocarditis. When inserting or removing an IUD, these patients should be given prophylactic antibiotics.
Levonorgestrel in low doses can affect glucose tolerance, and therefore its blood levels should be regularly checked in women with diabetes and using Mirena. However, as a rule, there is no need to change therapeutic prescriptions in women with diabetes using Mirena. Some manifestations of polyposis or endometrial cancer may be masked by irregular bleeding. In such cases, additional examination is necessary to clarify the diagnosis.
Mirena is not a first choice treatment for young women who have never been pregnant, or for postmenopausal women with severe uterine atrophy.
With estrogen monotherapy, the incidence of endometrial hyperplasia can reach 20%. In a clinical study of the use of Mirena (201 perimenopausal women and 259 postmenopausal women) during a 5-year observation period in a group of postmenopausal women, no cases of endometrial hyperplasia were observed.
Oligo- and amenorrhea. Oligo- and amenorrhea in women of childbearing age develops gradually, in approximately 20% of cases of Mirena use. If menstruation is absent within 6 weeks after the start of the last menstrual period, pregnancy should be excluded. Repeated pregnancy tests for amenorrhea are not necessary unless there are other signs of pregnancy.
When Mirena is used in combination with continuous estrogen replacement therapy, most women gradually develop amenorrhea over the first year.
Infections of the pelvic organs. The guide tube helps protect Mirena from microbial contamination during insertion, and the Mirena insertion device is specially designed to minimize the risk of infection. When using copper-containing IUDs, the maximum risk of pelvic organ infection occurs in the first month after installation of the system; subsequently the risk decreases. A number of studies have shown that the incidence of pelvic infections in women when using Mirena is lower than when using copper-containing IUDs. Having multiple sexual partners has been found to be a risk factor for pelvic infections. Infections of the pelvic organs can have serious consequences: they can impair fertility and increase the risk of ectopic pregnancy.
For recurrent endometritis or pelvic infections, as well as for severe or acute infections that are resistant to treatment for several days, Mirena should be removed.
Even in cases where only individual symptoms indicate the possibility of infection, bacteriological examination and monitoring are indicated.
Expulsion. Possible signs of partial or complete expulsion of any IUD are bleeding and pain. However, the system can be expelled from the uterine cavity unnoticed by the woman, which leads to the cessation of the contraceptive effect.
Partial expulsion may reduce the effectiveness of Mirena. Since Mirena reduces menstrual blood loss, an increase in blood loss may indicate expulsion of the IUD.
If the position is incorrect, Mirena must be removed. A new system may be installed at this time.
It is necessary to explain to the woman how to check the Mirena threads.
Perforation and penetration. Perforation or penetration of the body or cervix by an intrauterine contraceptive device occurs rarely, mainly during insertion, and may reduce the effectiveness of Mirena. In these cases, the system should be removed. There may be an increased risk of perforation when installing an IUD after childbirth, during lactation, and in women with a fixed uterine flexion.
Ectopic pregnancy. Women with a history of ectopic pregnancy, tubal surgery or pelvic infection are at higher risk of ectopic pregnancy. The possibility of ectopic pregnancy should be considered in the case of lower abdominal pain, especially if it is combined with cessation of menstruation or bleeding begins in a woman with amenorrhea. The incidence of ectopic pregnancy with Mirena is approximately 0.1% per year. The absolute risk of ectopic pregnancy in women using Mirena is low. However, if a woman with Mirena installed becomes pregnant, the relative likelihood of an ectopic pregnancy is higher.
Loss of threads. If, during a gynecological examination, the threads for removing the IUD cannot be detected in the cervical area, it is necessary to exclude pregnancy. The threads can be drawn into the uterine cavity or cervical canal and become visible again after the next menstruation. If pregnancy is ruled out, the location of the threads can usually be determined by careful probing with an appropriate instrument. If the threads cannot be detected, the IUD may have expelled from the uterine cavity. Ultrasound can be used to determine the correct placement of the system. If it is unavailable or unsuccessful, X-ray examination is used to determine the location of Mirena.
Delayed follicular atresia. Since the contraceptive effect of Mirena is due mainly to its local action, women of childbearing age usually experience ovulatory cycles with rupture of follicles. Sometimes follicular atresia is delayed and follicular development may continue. Such enlarged follicles cannot be clinically distinguished from ovarian cysts. Enlarged follicles were found in 12% of women using Mirena. In most cases, these follicles do not cause any symptoms, although sometimes they are accompanied by pain in the lower abdomen or during sexual intercourse. In most cases, enlarged follicles disappear on their own within two to three months of observation. If this does not happen, it is recommended to continue monitoring with ultrasound, as well as therapeutic and diagnostic measures. In rare cases, it is necessary to resort to surgical intervention.
Influence on the ability to drive a car and operate machinery. Not observed.
Conditions for dispensing from pharmacies
On prescription.
Storage conditions
List B.: In a dry place, protected from direct sunlight, at a temperature of 15-30 °C.Currently, 2nd and 3rd generation contraceptives are recommended for the installation of an intrauterine contraceptive device.
BRIEF HISTORY OF THE DEVELOPMENT OF INTRAUTERINE CONTRACEPTION Modern science does not have reliable information about the time of the first use of intrauterine contraception. It is believed that Hippocrates could have used in his practice some devices introduced into a woman’s uterine cavity, which protected her from pregnancy. The first intrauterine device, which became the predecessor of modern contraception, was invented in Germany in 1902, but since gonorrhea was widespread and poorly treated at that time, doctors reacted negatively to such IUDs. It is believed that intrauterine contraception has been thoroughly explored since 1909, when Dr. Richter from Waldenburg published the article “A New Method for Preventing Pregnancy” in a popular German medical journal. The author proposed using a contraceptive made of two silk threads and a bronze thread connecting them, twisted into a ring, which was inserted into the uterine cavity through a metal catheter (Richter R., 1909). However, Richter's invention was not widely used. The next gynecologist who made a major contribution to the creation and improvement of the IUD is considered to be Grafenberg, known as the author of the first study on determining the time of ovulation (Thiery M., 1997). Since 1920, he began working on the creation of a new intrauterine device. At first, Grafenberg experimented with various designs made from silkworm threads (1924); later, as a result of creative research, the famous Grafenberg ring appeared from silk threads braided with German silver wire (an alloy of copper, nickel and zinc). Publications 1928-1930 made the invention famous outside of Germany. In 1929, the London Commission for the Safety of Medicines found the Grafenberg silver ring acceptable for contraception in women with psychosexual disorders. After the introduction of such a contraceptive, stress due to fear of pregnancy was relieved, but a high percentage of expulsions was observed, which was a serious drawback of the Grafenberg ring and was eliminated in 1934 by the Japanese Ota, who improved the intrauterine ring. The Grafenberg and Otha rings were forgotten during the Second World War. However, in the first decade after it, the population in many countries grew rapidly, and this provided an incentive to continue scientific developments in the field of contraception, as a result of which it was possible to significantly improve the design of the IUD and reduce the likelihood of side effects.
in 1961, Lipps created an IUD with a serpentine configuration in the form of a double letter S, which was later named after the author (Lipps loop). This device was made of ethylene-vinyl acetate copolymer, had elasticity and flexibility, and was easily inserted into the syringe guide and then into the uterine cavity without dilating the cervical canal. It was the first device to have a nylon thread attached to the bottom of the device to make it easier to remove the IUD and also make it easier to monitor its presence in the uterine cavity. The rounded and thickened top tip of the loop reduced the risk of perforation. In subsequent years, several more IUDs were invented, differing in size, shape, material and other parameters. All of these non-medicated, plastic IUDs were classified as first generation. In 1969, the second generation of IUDs appeared - copper-containing coils. In 1976, the third generation IUDs entered the pharmaceutical market - hormone-releasing intrauterine systems, which today are considered one of the best intrauterine contraceptives. |
- The second generation of intrauterine contraceptive devices is intrauterine devices containing copper (Cu), silver (Ag) and gold (Au).
The second generation of IUDs appeared in 1969, when a group of scientists led by Zipper J. discovered the contraceptive effect of copper during experiments on rabbits, which was added by Tatum N. to the core of the spiral of a plastic IUD. In the course of further research, scientists came to the conclusion that the use of a silver core in the copper rod of the spiral slows down the corrosion processes of copper, while increasing the spermatotoxic effect and the duration of the IUD. This discovery has been put into practice in new models of IUDs with the additional inclusion of silver.
Currently, there are a large number of different IUD models that differ from each other By form: T-shaped
T-shaped IUDs are made of polyethylene with the addition of barium sulfate. The leg of the contraceptive, in some models and the hanger of the contraceptive, is wrapped with copper wire. Conductor diameter 4.4 mm. Introduction: the "withdrawal" technique. F-shaped
F-shaped IUDs have a smaller horizontal dimension than other IUDs, have increased flexibility and do not irritate the uterine angles. Subtle-shaped protrusions on the shoulders of the contraceptive reduce the percentage of expulsions, fix the contraceptive in the highest possible position and do not stretch the uterus. These include Multiload (Multiload Cu 250, Multiload Cu 375). The diameter of the pistonless conductor is 12 mm (the shoulders remain outside the conductor). Introduction: "retraction" technique. ring-shaped
A ring-shaped IUD is an intrauterine contraceptive device in the form of a plastic closed ring with an internal rod around which copper is placed. There are modifications with a silver core as a copper protector, which increases the service life to 7-8 years. At the lower pole of the ring there is a loop for attaching control threads. Conductor with a diameter of 4 mm. Introduction: the “retraction” technique, in the presence of a piston - “withdrawal”.
The ring-shaped form of the contraceptive practically eliminates its expulsion, which makes it possible to recommend widespread use immediately after an abortion, in the postpartum period, with ICI, as well as in women with expulsion of IUDs of other models in the past. in the form of number 7
The intrauterine contraceptive in the form of the number 7 - Cu 7 Gravigard - was produced in two sizes: standard (26x36 mm) and mini (22x28 mm) To size: standard short mini type
Multiload Cu-250 is available in three types: standard - for the uterus with a probe length of 6-9 cm; short - for a uterus 5-7 cm long; mini-type - for a uterus less than 5 cm long. The vertical size of these products is 35, 29 and 24 mm, respectively.
Multiload Cu-375 is available in two types: standard - for a uterus with a probe length of 6-9 cm and mini-type - for a uterus with a length of 5-8 cm. The length of the first IUD is 35 mm, the second - 29 mm.
The ring-shaped IUD Juno Bio-T is available in two sizes: ring diameter No. 1 - 18 mm (for nulliparous women), No. 2 - 24 mm (for women who have given birth). By amount of copper:(the numbers in the name of the intrauterine contraceptive device indicate the amount of copper surface area in mm2) with a relatively low copper content with a large amount of copper (more than 300 mm2) On the inclusion of silver and gold in the contraceptive with silver core
Despite the creation of more than 100 models of IUDs, at present, in order to increase the efficiency and duration of use, reduce complications and adverse reactions, the search for optimal shapes, sizes, surface areas of copper and other inclusions in IUDs continues.
- Intrauterine contraceptives containing an analogue of the female sex hormone are the third generation of intrauterine contraceptives.
These drugs emerged as a result of attempts to combine the advantages of hormonal and intrauterine contraception, on the basis of which hormone-releasing intrauterine contraceptive systems were created. As a result, Progestasert entered the market in 1976 (Alza Corporation, USA). However, this system did not become popular due to the short duration of the hormone’s action. It was later replaced by a levonorgestrel-releasing intrauterine system (LNG-IUS), registered in Russia under the name Mirena (another name for Levonov). Currently, this system is recognized as one of the best means of intrauterine contraception. The diameter of the system conductor is 4.75 mm, the dimensions of the system are 32x32 mm. Introduction: the "withdrawal" technique.
Indications |
Contraindications |
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The ideal IUD user is a parous woman with a monogamous sexual relationship and a low risk of contracting an STD, regardless of her age. Nota bene! Serial monogamy increases the risk of contracting an STD, and the presence of an IUD increases the risk of developing pelvic inflammatory disease and subsequent adhesions in the fallopian tubes. |
absolute (first 4) and relative, quite a wide range
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Benefits of the IUD
- High efficiency. The pregnancy rate is very low - 0.3 per 100 woman-years.
- Relatively cheap contraceptive
- Effective for 5-8 years.
- Women over 40 years of age may not have their IUD removed until one year after menopause without adverse effects.
- Ease of administration - usually during menstruation.
- Can be used as emergency contraception on the 5th day after possible ovulation - the 19th day of the menstrual cycle.
- Low incidence of ectopic pregnancy with IUD
Negative properties of the IUD
- Pain - insertion of the IUD may be painful; in such cases, local paracervical anesthesia is performed.
- Menstruation - a moderate increase in monthly blood loss, but no changes in the iron content in the blood are observed. Rarely - intermenstrual and postcoital bleeding.
- Loss of IUD threads - in most cases, they can be removed from the cervical canal using special curved forceps. Only 4% of women need pain relief to remove the IUD. It is advisable to have an ultrasound to determine the location of the IUD.
- Inflammatory diseases of the pelvic organs - clinical studies have shown that the risk of these diseases after insertion of an IUD is only 0.2%.
- Need to remember:
- The IUD must be inserted under sterile conditions;
- Patients should not show signs of infection, since microorganisms during the insertion of an IUD can ascend to infect the genitals. Chlamydial infection is detected in 6-8% of patients attending family planning clinics, but since it can occur without clinical symptoms, a screening examination is necessary to detect chlamydia before insertion of an IUD;
- the group at increased risk of infectious diseases are young, sexually active women, as well as those who have many partners;
- Prophylactic antibiotics should be used when chlamydial infection is suspected or emergency contraception is indicated. Over the next 6 weeks, an examination is necessary to identify any other inflammatory diseases of the pelvic organs. Most often, complications associated with inflammatory diseases occur within 20 days after insertion of the IUD.
- If actinomycosis is detected and
- the patient has no symptoms of the disease, removal of the IUD and re-insertion after 3 months is indicated if the results of the smear examination are normal; antibiotics are not indicated;
- the patient has symptoms (pain in the pelvic organs), the IUD is removed and cultures are taken from the cervical canal, and antibiotic therapy is administered. Cervical smears are recommended 6 months after IUD insertion and then annually to screen for actinomycosis-like organisms.
- Pregnancy. If pregnancy occurs due to an IUD, careful removal of the intrauterine device in the early stages of pregnancy is indicated. This reduces the rate of spontaneous miscarriages and complications from 54 to 20%. Ectopic pregnancy must be excluded.
- Perforation. This occurs rarely (1:1000 injections) and is usually painless. The IUD threads disappear and ultrasound is indicated to determine the location of the IUD. To remove the IUD, it is necessary to perform laparoscopy or laparotomy.
Preparation for insertion of the IUD and conditions for insertion of the IUD
- Bimanual examination and ultrasound of the pelvic organs to determine the topography, size of the uterus and the distance between the angles. The difference between the length of the uterine cavity and the length of the intrauterine contraceptive device being placed should not exceed 1.5 cm (1.25-1.75).
- Study of the degree of purity of vaginal contents and discharge from the cervical canal
- The condition for administration is I-II degree of purity, absence of inflammatory process in the genitourinary organs and intestines
- No pregnancy
Introduction dates
- The optimal time for inserting an IUD is the last days of menstruation or the first days after its end. This is done in order to exclude the possibility of using an IUD against the background of an existing, undiagnosed pregnancy.
- After an uncomplicated artificial medical abortion, it is administered immediately (after 10 minutes) or no earlier than after 6 weeks.
- After normal spontaneous birth - immediately (after 10 minutes) or after 4-6 weeks (only Copper-T 380A), as well as after 5-6 months, if a woman uses the lactational amenorrhea method for contraception.
- After caesarean section - no earlier than 12 weeks.
- In case of emergency contraception, it prevents the onset of three out of four pregnancies; can be administered within 5 days after ovulation, regardless of the number of sexual intercourses. The IUD may remain in the uterus to continue contraception or be removed during the next menstrual period.
Pain relief methods
In most cases, it is performed without anesthesia. Paracervical blockade can be used when inserting the Mirena IUD, as well as when installing an IUD in nulliparous women.
IUD insertion technique
The installation technique for different types of IUDs is different (different insertion tubes, conductor piston, type of packaging), so you should read and follow the instructions on the technique for inserting the contraceptive each time. Depending on the IUD model, various techniques are used for filling the contraceptive into the conductor and various techniques for its insertion: 1) the “withdrawal” technique - used when installing T-shaped and ring-shaped IUDs, 2) the “retraction” technique - used when inserting F-shaped IUDs.
In general, the introduction method is as follows. Before the procedure, the woman empties her bladder and sits on a chair. A bimanual examination is performed to determine the size and position of the uterus. Then the external genitalia is treated, the cervix is exposed in the speculum and treated with an antiseptic solution. Then, under aseptic conditions, the cervix is taken with bullet forceps (fixed by the front lip with bullet forceps) and lowered to straighten the canal. The length of the uterus is determined using a probe and intrauterine pathology is excluded, if necessary, local anesthesia and dilation of the cervical canal 5 minutes after the administration of the anesthetic.
An index ring is installed on the guidewire in accordance with the length of the uterus along the probe. A guidewire with an intrauterine device is inserted into the cervical canal and advanced into the uterine cavity. During advancement, gentle traction of the conductor is performed.
After insertion of the conductor, the latter is slightly removed from the uterine cavity using the “withdrawal” technique. The piston remains motionless and supports the contraceptive. At this time, the horizontal branches of the T-shaped contraceptive open into the uterine cavity, which ensures the correct position of the IUD and eliminates the risk of perforation.
Then, by upward traction, the conductor returns to its original position with the piston stationary. This ensures the final location of the contraceptive at the fundus of the uterus. After which the piston and conductor are removed from the uterine cavity, the control threads are cut at a distance of 2-3 cm from the external os of the cervix. Bullet forceps are removed from the cervix, the vaginal walls and cervix are treated with a disinfectant solution and the speculum is removed from the vagina.
When using the “retraction” technique, the guidewire with the IUD is inserted into the uterine cavity with upward traction until the index ring comes into contact with the cervix. After which the guide is removed, the control threads are cut 2-3 cm from the cervix.
Nota bene! When performing the manipulation, it is unacceptable to touch the uterine probe and the IUD guide to the vaginal walls and speculum. Technique for inserting the Mirena T-shaped intrauterine system [show]
Instructions for inserting Mirena
Installed only by a doctor!
Mirena is supplied in sterile packaging. Mirena is sterilized with ethylene oxide. Do not unpack to avoid compromising sterility. For single use only. Do not use Mirena if the inner packaging is damaged or opened. Use by date indicated. Using a guide, Mirena is inserted (Diagram 1) into the uterine cavity within 7 days from the start of menstruation or immediately after medical termination of pregnancy, carefully following the attached instructions. Mirena can be replaced with a new IUD on any day of the menstrual cycle.
Preparing for the introduction
Carry out an examination to determine the size and position of the uterus and to exclude acute cervicitis, pregnancy or other gynecological contraindications.
Visualize the cervix using speculums and completely clean the cervix and vagina with a suitable antiseptic solution.
If necessary, use the help of an assistant.
Grasp the upper lip of the cervix with forceps. Using gentle traction with forceps, straighten the cervical canal. The forceps should be in this position during the entire insertion of the Mirena to ensure gentle traction of the cervix towards the inserted instrument.
Carefully moving the uterine probe through the cavity to the fundus of the uterus, determine the direction of the cervical canal and the depth of the uterine cavity (the distance from the external os to the fundus of the uterus), exclude septa in the uterine cavity, synechiae and submucosal fibroids. If the cervical canal is too narrow, expansion of the canal is recommended and the use of analgesics/paracervical blockade is possible.
Introduction
Technique for inserting the Mirena IUD (schematic demonstration)
IMPORTANT INFORMATION!
If you have doubts that the system is installed correctly, check the position of the Mirena, for example, using ultrasound or, if necessary, remove the system and insert a new, sterile one. Remove the system if it is not completely in the uterine cavity. The removed system should not be reused.
Technique for inserting a T-shaped intrauterine device [show]
The technique for inserting a T-shaped intrauterine device is similar to the technique for inserting a T-shaped intrauterine system. It is carried out using the “withdrawal” method: the prepared intrauterine contraceptive is inserted into the uterine cavity up to the index ring. The guidewire and piston are inserted simultaneously. After which the conductor is fed back to the ring on the piston. The piston is motionless. Next, the conductor, with the piston stationary, is returned to its original position, which ensures the final placement of the contraceptive in the correct position at the fundus of the uterus. After which the piston and conductor are removed, the control threads are cut at a distance of 2-3 cm.
Insertion technique for the T380A copper IUD
(video from WHO website)
Technique for inserting a ring-shaped and F-shaped IUD [show]
Complications
- Pain syndrome. In nulliparous and emotional women, when an IUD is inserted, a vasovagal reaction may develop, the causes of which are the narrowness of the cervical canal, the relatively small size of the uterus, and emotional reactions. Some patients may experience lower abdominal pain and nausea immediately after IUD insertion. To prevent vasovagal reaction and pain during installation (especially the Mirena intrauterine system), paracervical anesthesia is recommended: 1-2 ml of a 1% lidocaine solution is administered paracervically at 4 and 8 hours. Pain relief occurs within 2-5 minutes. When performing anesthesia, it is necessary to monitor the possible appearance of symptoms of allergy and intoxication (nausea, headache, dizziness, tinnitus, tingling in the lips).
If a vasovagal reaction or severe pain occurs immediately after the introduction of a contraceptive, it is necessary to use painkillers and antispasmodics. In the future, the woman can take non-steroidal anti-inflammatory drugs for 1-2 days.
Severe pain immediately after installation may occur when using a larger contraceptive or due to improper opening in the uterine cavity. In these situations, it is necessary to conduct an ultrasound and further decisions based on its results. It is possible to remove the IUD and reinsert a smaller IUD with strict adherence to the insertion technique.
- Expulsion - more often in non-pregnant and young people; sometimes the insertion of the IUD is not deep enough. Careful selection of IUD size; use of bullet forceps during manipulation, insertion of an IUD when the conductor reaches the uterine fundus
- Bloody or serous discharge in the first days after administration - often; no treatment required
- Intermenstrual moderate bleeding, menorrhagia - less often; combined hormonal contraceptives according to a cyclic scheme for 3 cycles or Norkolut 1 tablet from the 13th to the 23rd dmc. as well as iron preparations, calcium gluconate, ascorutin, vitamin E, indomethacin. When using Mirena, intermenstrual bleeding and menorrhagia are practically eliminated.
- Very profuse menorrhagia that cannot be treated is rare; spiral removal
- Inflammation of the genitals - 0.4-4.4%, with copper-containing IUDs inflammation is less common, in young people it is more common; Antibiotic therapy or removal of the IUD - decided individually
- Perforation of the uterus - during insertion of an IUD occurs in less than three cases per 1000, the risk is inversely proportional to clinical experience and directly proportional to the time after birth (insert no earlier than 6 months after birth).
Perforation of the uterus also occurs long after insertion of the IUD. When perforation occurs in a direction other than the plane of insertion (including when the vertical base of the IUD perforates the cervix), it can be assumed that the cause was strong uterine contractions aimed at expelling the IUD. If perforation occurs in the plane of insertion of the IUD, it is most often a consequence of partial perforation during insertion.
Often signs of partial or complete perforation of the uterus are the “loss” of the IUD thread and difficulty in removing it. In other cases, women experience pain in the abdomen or pelvic area, and bleeding occurs. If attempts to detect the IUD using ultrasound fail, the position of the IUD must be determined using x-ray. Transsection or laparoscopic removal of the IUD is indicated. The scope of the operation is individual.
- The occurrence of pregnancy due to an IUD - there is no need to recommend its termination on the basis that abnormal development of the fetus is possible. The risk is very low. If the pregnancy is carried to term, an increase in the incidence of complications, as a rule, is not observed. The IUD is “born” along with the placenta or removed during a cesarean section. Removal of the IUD during pregnancy is not recommended, because may cause spontaneous miscarriage.
Information for a patient who has an IUD inserted
REMINDER FOR WOMEN USING INTRAUTERINE CONTRACEPTION METHOD You have chosen a modern, effective, reliable, safe, long-acting, convenient, widespread method in the world to prevent pregnancy. Intrauterine contraception is the introduction of small-sized means of various shapes into the uterine cavity. The period of adaptation of the body to the IUD lasts about 3 months.
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IUD removal technique
The IUD can be removed at any time during the menstrual cycle. It is optimal to remove the IUD during menstruation, on the day of maximum bleeding. To remove it, you need to grab the thread with a forceps and carefully pull it using traction. Traction of the thread from the vagina is carried out until the IUD comes out completely.
In 2% of cases, removal of an intrauterine device (IUD) may be difficult. If the IUD does not come out easily, bullet forceps can be used to straighten the cervical canal. If removal is still difficult, an attempt can be made to dilate the cervix or (if the IUD is removed outside of menstruation) encourage the woman to return during her period, when the cervix is typically softer.
If the threads are torn off during the removal of the IUD, further removal of the contraceptive is carried out using a special hook, which is carefully inserted through the cervix into the uterine cavity and rotated 180-360 degrees. In many cases, the hook will wrap around the vertical base of the IUD, move downwards and rest against the spherical thickening at the end. The IUD can then be easily removed through the cervical canal.
If during examination it is not possible to detect the threads of the IUD and the woman denies expulsion, it is necessary to conduct an ultrasound and/or R-study to determine the presence of the IUD and its location. If perforation of the uterine wall and intraperitoneal location of the IUD is detected, it should be removed as early as possible. This is especially important with a copper IUD because copper ions can cause a local inflammatory response. Most intra-abdominal IUDs can be removed laparoscopically. However, the woman must be notified of the possible need for laparotomy to remove the IUD or in the case of intra-abdominal complications, including omental adhesions and intestinal perforations.
Method of restoring the normal position of the IUD
Outpatient hysteroscopy, before the introduction of new forms of hysteroscopes (especially fiberscopes), classified as diagnostic, began to become more widespread with the development of technical capabilities, and is now called “office hysteroscopy.” The introduction of office hysteroscopy into clinical practice has significantly expanded the possibilities of diagnosing and treating intrauterine pathology on an outpatient basis without dilating the cervical canal and without anesthesia, which has increased the comfort of the procedure for women and reduced the need for hospitalization of patients.
Office hysteroscopy was thus an indispensable way to combine diagnostic and therapeutic hysteroscopy and transfer them to the category of therapeutic hysteroscopy, which corresponds to the concept of “See and treat”. This approach made it possible to reduce the number of cases of premature removal of the IUD and improve the quality of intrauterine contraception by restoring the normal position of the IUD in the uterine cavity. The technique of restoring the normal position of the IUD in the uterine cavity, as well as removing a polyp in the presence of an IUD in the uterine cavity, can be found in the video materials of Czech authors:
- MUDr. David Kuzel, CSc., Gynekologicko-porodnicka clinic 1. LV UK a VN Praha, Apolinarska 18, 128 51, Praha 2, Ceska Republika
- MUDr. Petr Kovar, Gynprenatal s.r.o., Pracoviste ambulantni hysteroskopie, Mistni 9, 736 01 Havirov, Ceska Republika
INTRAUTERINE DEVICES honey.
Advantages
High efficiency - the pregnancy rate when using intrauterine devices (IUDs) is 2-3 cases per 100 women per year
No concomitant systemic effect on metabolism
For long-term use, a single procedure (insertion of an IUD) is sufficient.
No teratogenic effect
Reversibility of contraceptive effects
Elimination of psychological discomfort associated with the need to take care of preventing unwanted pregnancy before each sexual intercourse. Flaws
A large number of contraindications
High risk of developing inflammatory processes of the uterus and its appendages
Increased blood loss during menstruation
High risk of uterine perforation. Mechanism of action
Inert (non-medicated) IUDs - the action is associated with a local aseptic inflammatory reaction caused by the presence of a foreign body in the uterus.
Contractions of the myometrium, increased peristalsis of the fallopian tubes - the fertilized egg passes through faster
fallopian tubes and enters the uterine cavity before the conditions for its implantation arise.
Inflammation of the endometrium (not always), which also prevents implantation. The addition of copper enhances the inflammatory response.
After removal of both copper-coated and non-copper IUDs, the inflammatory reaction quickly disappears, followed by restoration of fertilization ability.
Spermatotoxic and ovotoxic effects of copper ions.
Medicinal IUDs with progesterone exert their contraceptive effect locally in the endometrium and cervix - the endometrium does not undergo the changes necessary for implantation, changes in the cervical mucus make it difficult for sperm to penetrate.
Types
Copper-containing products should be replaced every 6 years due to the gradual dissolution of copper
TSi-380A: service life - 5 years
TCu-220, TCu-220B - 3 years
TCu-200Ag - 3 years
TCu-380Ag - 4 years
Multiload C 375 - 5 years
Progestin-containing T-shaped IUDs should be replaced every year; Progesterone reserves are depleted after 12 months (Progestasert-T, Levonorgestrel-20). IUD insertion technique
Possibly on any day of the menstrual cycle
Before insertion, it is necessary to carefully collect anamnesis, conduct a vaginal examination, and assess the degree of cleanliness of the vaginal discharge, cervical canal and urethra.
When inserting an IUD, excessive pressure using force is unacceptable.
The insertion of an IUD should only be carried out by a specialist with the appropriate equipment.
IUD removal technique. The cervix and vagina are treated with an antiseptic solution, the IUD threads are grabbed with a forceps or tweezers. Remove carefully and slowly. If resistance appears, it is necessary to probe the uterine cavity, expand the cervical canal, after which the IUD threads should be pulled again. If the above measures are ineffective, it is necessary to remove the IUD using diagnostic curettage of the uterine cavity in an inpatient setting.
Indications. The IUD is considered the optimal method of contraception for women who have given birth and have one sexual partner. Contraindications
Absolute
Pregnancy
Acute and subacute inflammatory processes of the external and internal genital organs
No history of childbirth
Adolescence
Relative: abnormalities of the reproductive system, infantile uterus (uterine cavity length less than 6 cm), cervical deformation, cervical erosion, suspicion of endometrial hyperplastic process, menstrual irregularities, recurrent inflammatory processes of the uterus and its appendages, blood diseases (including including anemia), extragenital diseases (subacute endocarditis, diabetes mellitus, chronic inflammatory extragenital diseases with frequent exacerbations), allergy to copper, history of ectopic pregnancy, presence of more than one sexual partner, frequent sexual intercourse (more than 5 times a week), stenosis cervical canal.
Recommendations for patients
Sexual activity should be resumed only after the first examination, carried out 3-5 days after insertion of the IUD
Follow-up examinations should be performed every 3-6 months
After the end of menstruation, the position of the IUD threads should be checked (procedure
conducted by a woman)
Situations requiring consultation with a doctor:
Absence of IUD threads when checked after the end of menstruation
Increased body temperature, the appearance of pain in the lower abdomen, pathological discharge from the genital tract, changes in the nature or delay of menstruation. Complications
Menstrual irregularities are the main reason for IUD removal
Hyperpolymenorrhea (3.7-9.6%) - for correction, it is recommended to take prostaglandin synthesis inhibitors during the first 3 menstruation
Acyclic uterine bleeding (5-15%) - if other pathological processes are excluded, hemostatic agents or combined oral contraceptives are prescribed for 1-3 cycles
If bleeding continues, the IUD must be removed.
Perforation of the uterine fundus
Primary perforation during insertion occurs in approximately 1 case per 1000 insertions.
Perforation of the uterine fundus must be excluded if, during examination, the doctor does not detect telltale threads in the cervix, and the woman does not notice the IUD falling out
The IUD may rotate and the thread may be pulled into the uterine cavity.
If an IUD is found outside the uterus, it must be removed to avoid possible complications (for example, adhesions and intestinal obstruction).
Infection.
The incidence of pelvic infection is highest during the first 2 weeks. Factors that increase the risk of infection:
History of pelvic inflammatory disease
No obstetric history of childbirth
Age less than 25 years
A large number of sexual partners.
The incidence of salpingitis in IUD users is 3 times higher than in those who use diaphragms or oral contraceptives. The risk is especially high in nulliparous women under 25 years of age.
Treatment
Removal of the IUDAntibiotic therapy A unilateral tubo-ovarian abscess, which sometimes occurs in women with an IUD, can be removed without general sanitation of the pelvic organs. Such an abscess develops only after the use of an IUD.
Expulsion (spontaneous loss of the IUD from the uterine cavity) - 2-16%. When re-expulsing the IUD, you should resort to a different method of contraception.
Pregnancy (1-1.8%).
Pain (3.6%) - causes may be expulsion of the IUD, inflammatory processes, spontaneous abortion, increased secretion of prostaglandins, ectopic pregnancy. Complications that arise during pregnancy
Spontaneous abortion occurs in about 50% of cases with an IUD. If pregnancy occurs, it is recommended to remove the IUD to avoid infection. When an IUD is removed early in pregnancy, the rate of spontaneous abortion is approximately 20-30%
Ectopic pregnancy - chance is 3 to 7% compared to 1 to 2% for women without an IUD
Prematurity is premature birth in 12-15% of all pregnancies that result in the birth of a live child. Premature birth may be associated with IUD-induced irritation of the myometrium in the third trimester of pregnancy.
HORMONAL CONTRACEPTION Hormones for contraception began to be used in the late 50s. Currently, more than 120 million women use hormonal contraception.
Hormonal contraception and neoplasms. There is no statistically reliable data on the relationship between the use of oral contraceptives and the development of neoplasms of the breast, cervix, endometrium or ovaries.
Breast
Progestins counteract the stimulating effects of estrogens on breast tissue
Benign breast diseases occur less frequently in women using oral contraceptives
The incidence of breast cancer has not changed over the past 15-20 years, despite the widespread use of oral contraceptives.
Oral contraceptives do not affect the incidence of cervical carcinoma, but they do not prevent the penetration of potentially carcinogenic factors, such as human papillomaviruses and herpes simplex.
Endometrium
Progestins compete with estrogens for binding sites in endometrial cells
Progestins reduce the stimulating effect of estrogens and prevent the transition of normal endometrial proliferation to hyperplasia
The suppressive effect of progestins on the endometrium has led to their use as a therapeutic agent in the treatment of some cases of adenomatous hyperplasia.
Ovaries
Functional cysts occur less frequently when taking oral contraceptives
A reduction in the incidence of ovarian cancer is suggested, but not considered proven.
Classification
Combined estrogen-gestagen drugs (single- and multiphase)Mini-pills (progestogens)
Injectable (long-acting) hormonal contraceptives
Subcutaneous implants. Combined estrogen-protestogen drugs
The composition includes an estrogenic component (most often ethini-estradiol, less often mestranol) and a progestogen component. Preparations of different generations contain progestogens of different chemical structures (third generation drugs are optimal). The content of the estrogen component is considered to be 30-35 mcg, the progestogen component - 50-150 mcg, for a contraceptive effect. Drugs with higher contents should be used in the treatment of various gynecological diseases.
Mechanism of contraceptive action
Suppression of ovulation - estrogens and progestogens suppress the synthesis of gonadotropins and prevent ovulation
Cervical mucus becomes thick and viscous, which prevents sperm from moving through the cervical canal.
The endometrium under the influence of progestogens does not undergo the changes necessary for implantation of a fertilized egg.
Classification and regimen
Monophasic
The dose of hormones in each tablet is constant, regardless of the day of the menstrual cycle. Number of tablets per package - 21
Drugs: Demoulen, Diane-35, Miniziston, Rigevidon, Silest, Femoden, Marvelon
Dosage regimen: must be taken from the first day of the menstrual cycle (the day menstruation begins) for 21 days, then take a break for 7 days
If taking the drug begins on the 5th day of the cycle, then for 7 days it is necessary to use additional methods of contraception (for example, barrier).
Polyphase
The concentration of estrogen is constant, and the content of progesterone increases by 2 or 3 times (two- and three-phase preparations, respectively)
Preparations: two-phase - Anteovin (taken from the 5th day of the menstrual cycle for 21 days with a 7-day interval), three-phase - Triregol, Triziston, Triquilar, Trinovum, Trinordiol 21, Sinphase - from the 1st day of the menstrual cycle for 21 days from 7- daily interval (it is necessary to warn the patient that the first menstruation while taking the drug will occur on the 23-24th day)
Some companies produce packages of 28 tablets - 21 tablets contain hormonal substances, the remaining 7 are placebo (sometimes contain iron supplements).
Note
The most optimal for contraception are triphasic drugs and monophasic ones containing third-generation progestogens (Marvelon, Mercilon, Silest).Contraceptive effectiveness - 0-1 pregnancy per 100 women per year.
Indications
The need for reliable contraception
The need for contraception for young nulliparous women (multiphasic drugs are not recommended for adolescents; monophasic drugs containing third-generation progestogens are considered optimal for this age group)
Ensuring adequate spacing between births
Contraception with a family history of ovarian cancer
Therapeutic indications (menstrual dysfunction, algomenorrhea, premenstrual syndrome, functional ovarian cysts, menopausal syndrome, posthemorrhagic anemia, resolution of inflammatory processes of the uterus and its appendages, rehabilitation after ectopic pregnancy, rosacea, oily seborrhea,).
Note
When using hormonal contraceptives, it is necessary to exclude active smoking (more than 10-12 cigarettes/day).
Contraindications
Absolute: pregnancy, thromboembolic diseases, cerebral vascular damage, malignant tumors of the genital organs or mammary glands, severe liver dysfunction, cirrhosis. The listed somatic pathology is considered an absolute contraindication, even if there is a history of it.
Relative: severe toxicosis of the second half of pregnancy, history of idiopathic jaundice, herpes in pregnant women, severe depression, psychosis, bronchial asthma, severe arterial hypertension (above 160/100 mm Hg), sickle cell anemia, severe diabetes mellitus, rheumatic heart disease, severe kidney disease, varicose veins and thrombophlebitis, calculous cholecystitis, hydatidiform mole (until the disappearance of human chorionic gonadotropin in the blood), bleeding from the genital tract of unknown etiology, obesity III-IV
degrees, active smoking (more than 10-12 cigarettes/day), especially over the age of 35 years.
Side effects
Etrogen- and gestagen-dependent. The type of side effects depends on the content of estrogens and gestagens in a particular drug, as well as on individual sensitivity to them
Estrogen-dependent: nausea, increased sensitivity of the skin of the mammary glands and/or their enlargement; fluid retention, causing cyclic weight gain; increased vaginal secretion; ectopia of the columnar epithelium of the cervix; headache; dizziness; irritability; cramps in the calf muscles; chloasma; arterial hypertension; thrombophlebitis
Gestagen-dependent (androgen-dependent): increased appetite and weight gain, depression, increased fatigue, decreased libido, rosacea, increased activity of the sebaceous glands of the skin, neurodermatitis, itching, rash, headaches, decreased duration of menstruation and decreased amount of blood released, hot flashes, vaginal dryness, candidal colpitis, cholestatic jaundice.
Early and late
Early: nausea, dizziness, enlargement and tenderness of the mammary glands, intermenstrual bleeding, abdominal pain. They usually occur in the first 3 months of drug use and go away without treatment.
Late: fatigue, irritability, depression, weight gain, decreased libido, visual disturbances, delayed menstrual-like reaction. Occurs 3-6 months after starting the drug.
Complications
Thromboembolism. Estrogens cause an increase in the concentration of a number of plasma coagulation factors, especially factor VII, presumably due to their effect on the liver. Antithrombin III levels fall during the first 10 days after starting oral contraceptives. The likelihood of thrombosis of both superficial and deep veins when using oral contraceptives is increased.
Diseases of the cardiovascular system. Women taking oral contraceptives have higher mortality rates from cardiovascular or cerebrovascular diseases (4 times). The most common cause is MI. The incidence does not depend on the duration of use of oral contraceptives
Morbidity and mortality from cardiovascular diseases associated with oral contraceptives are significantly lower when using drugs containing less than 50 mcg of estrogens
Women over 35 who smoke are at greatest risk.
Arterial hypertension - periodic measurement of blood pressure is necessary, especially when changing the drug or in cases when a woman first started using oral contraceptives
When using oral contraceptives, an increase in angiotensinogen content, plasma renin activity and angiotensin levels is noted. There is an increase in aldosterone secretion and sodium retention by the kidneys
The development of hypertension appears to be associated with the duration of oral contraceptive use; it is registered in approximately 5% of women 5 years after starting the use of oral contraceptives -c- In almost all women with arterial hypertension caused by the use of oral contraceptives, blood pressure returns to normal after stopping their use.
Amenorrhea caused by stopping taking pills occurs in 0.2-3.1% of cases and does not depend on the duration of use of oral contraceptives
35-56% of women with amenorrhea that occurred after stopping oral contraceptives had previously had menstrual irregularities
In case of amenorrhea, in any case, it is necessary to exclude a pituitary adenoma. In case of amenorrhea associated with discontinuation of contraceptives, it is necessary to check the level of prolactin in the blood serum.
Liver tumors - hepatocellular adenoma. The risk of occurrence increases when using oral contraceptives for 5 years or more. The tumor occurs with a frequency of 3 cases per 100,000 women per year.
Flaws
The need to take the drug daily
High risk of contracting sexually transmitted diseases
Possibility of developing side effects and complications. When the estrogen content is less than 30 mcg and the use of third-generation progestogens, the risk of side effects and complications is minimal.
Patient management
Strict monitoring of contraindications.
Gynecological examination once a year (colposcopy, cytological examination).
Transvaginal ultrasound either once a year, or in case of menstrual dysfunction (intermenstrual bleeding 3 months after starting the drug, false amenorrhea).
Examination of the mammary glands 1-2 times a year.
Blood pressure measurement. When diastolic blood pressure increases to 90 mm Hg. and above, discontinuation of oral contraceptives is indicated.
Regular clinical and laboratory examination of patients with complicated heredity, unexpressed disorders of the liver and kidneys.
Management of patients with developed side effects.
Weight gain - drugs with low androgenic activity, diet, exercise; cyclical body gain - drugs with low hormone content or their withdrawal.
Visual impairment (more often occurs when wearing contact lenses) - discontinuation of oral contraceptives, temporary refusal to use contact lenses, consultation with an ophthalmologist and neurologist.
Depression - discontinuation of oral contraceptives, prescription of vitamin B6 (20 mg/day), antidepressants (if necessary), consultation with a psychiatrist.
Scanty bleeding from the genital tract. - If it appears in the first 3 cycles from the start of taking the drugs, there is no need for treatment.
- After the first 3 cycles: if discharge appears in the first phase or in the middle of the cycle, then it is necessary to select a drug containing a large dose of estrogen; if discharge appears in the second phase, then in addition to a drug containing a large dose of estrogens, in the next cycle it is necessary to take a drug containing a large dose of gestagens.
- The ineffectiveness of these measures may be due to errors in taking medications or some organic pathology.
Delayed menstrual-like reaction (it is necessary to first assume the presence of pregnancy, especially if the rules for taking the drug are not followed).
The optimal duration of hormonal contraception ranges from 12 months to several years according to various authors.
Recommendations for patients
Strictly follow the drug dosage regimen and the 7-day interval. The drug must be taken at the same time of the day (morning or evening), with milk or water to prevent nausea.
If the tablet was not taken on time, you must take it as quickly as possible (within 12 hours). Within 14 days after missing a dose, contraception is considered unreliable, which requires the use of additional methods of contraception.
If a menstrual-like reaction does not occur on time, you should continue taking the drug and consult a doctor.
The combination of oral contraceptives and broad-spectrum antibiotics, antihistamines, anticonvulsants, analgesics, nitrofurans, barbiturates leads to a decrease in the contraceptive effect. It is recommended to use other methods of contraception until the next menstrual-like reaction.
After stopping the drug, pregnancy may develop already in the first cycle (rebound effect).
It is necessary to stop taking oral contraceptives 6 weeks before planned surgery.
4 If you want to have a child, you should stop taking oral contraceptives and use another method of contraception (preferably barrier) for 3 months.
Replacing one oral contraceptive with another, with a lower hormone content, is carried out by taking a new drug the next day after taking the last tablet of the previous one; when replacing a monophasic drug with a multiphasic one, more abundant and painful menstruation may occur.
If, after taking another tablet of the drug, for some reason vomiting occurs within 3 hours, then it is necessary to take another tablet; if diarrhea lasts for several days, it is recommended to use additional methods of contraception until the next menstrual-like reaction.
The drug should be stopped if:
sudden attack of severe headache
migraine attack
chest pain
visual impairment
difficulty breathing
jaundice
increase in blood pressure more than 160/100 mm Hg.
Scanty intermenstrual flow in the first months of taking the drug - you need to take additional
a tablet from a spare package (for multiphase medications, you must take a tablet intended for the same day), then the usual regimen for taking the drug. Postcoital contraception
WHO does not recommend postcoital medications (for example, Postinor) for use, because with a high frequency of side effects (menstrual irregularities occur in 40% of cases), they do not have a high contraceptive effect.
For contraception in case of undisguised sexual intercourse (rape, rupture of a condom), the so-called. emergency contraception (high contraceptive effectiveness). In the first 72 hours after undisguised sexual intercourse, take 2-3 tablets of a monophasic oral contraceptive (total dose of estrogen - at least 100 mcg), after 12 hours the dose is repeated in the same dose. Usually after 2 days spotting appears. The emergency contraception method is not recommended for use for more than 1 r/year. As an alternative, ethinyl estradiol 5 mg can be taken for 5 days.
Danazol in tablets of 400 mg 3 times with an interval of 12 hours.
Insertion of an IUD within 5 days after sexual intercourse.
After sexual intercourse close to ovulation, you can take a morning postcoital pill (if you have not used other methods of contraception)
The drug must be taken no later than 72 hours after sexual intercourse; preferably within 24 hours
Glucocorticoids, taken in large doses immediately after ovulation, change the condition of the endometrium, preventing implantation of the egg.
Due to the possible teratogenic effect of hormones, medical abortion is recommended in case of unsuccessful postcoital contraception and pregnancy.
Mini-pills contain microdoses of progestogens.
Preparations: Continuin, Micronor, Ovret, Exluton, Femulen.
The drug is used continuously, starting from the 1st day of the menstrual cycle.
Contraceptive effectiveness is 0.3-9.6 pregnancies per 100 women per year.
Recommendations for patients.
During the first 7 days, it is necessary to use additional methods of contraception.
If the drug is delayed by 3 hours, it is necessary to use additional methods of contraception for 7 days.
If you miss 1 tablet, it must be taken as soon as possible; if you miss 2 tablets, an emergency contraception method is indicated.
Intermenstrual bleeding in the first months - you should continue taking the drug; if intermenstrual bleeding continues, you should consult a doctor.
For prolonged diarrhea, you should resort to additional methods of contraception.
If you want to have a child, it is permissible to stop taking the drug immediately before the planned conception.
Indications
Lactation period (do not affect lactation function)
Senior reproductive age
Presence of contraindications to the use of estrogens
Obesity.
Limitations of the method
Relatively low effectiveness compared to combined oral contraceptives
Increased risk of developing ovarian cysts
Increased risk of ectopic pregnancy
Menstrual irregularities.
Injectable (long-acting) drugs. Long-acting progestogens without estrogenic and androgenic activity. The contraceptive effect is 0.5-1.5 pregnancies per 100 women per year.
The most commonly used drug is medroxyprogesterone (Depo-Provera-150): a progestin that suppresses ovulation by acting on the hypothalamic-pituitary axis. The drug also affects the condition of the endometrium and the secretion of cervical mucus (increased viscosity and fibrousness).
The usual dose is 150 mg IM every 3 months on the 5th day of the menstrual cycle (efficacy reaches 100%). Fertility restoration occurs after 4-24 months (usually after 9 months).
Indications: inability to take oral contraceptives daily, late reproductive age, lactation period, presence of contraindications to the use of estrogens, contraception in the early period after abortion.
Recommendations for patients
Additional methods of contraception should be used for 2 weeks after the first injection
Injections must be carried out every 3 months in a medical facility; the injection site must not be massaged
If you want to have a child, you should stop injections several months before the planned pregnancy.
It is necessary to consult a doctor if you have complaints of headaches, depression, weight gain, frequent urination, or heavy uterine bleeding.
Advantages: ease of use, high contraceptive effect, absence of pronounced metabolic changes (no estrogens), providing a therapeutic effect for algomenorrhea, premenstrual and menopausal syndromes, menstruation disorders, etc.
Complications: various menstrual cycle disorders (,). If they develop, it is necessary to stop taking the drug.
GnRH analogs
Superagonist buserelin is an analogue of gonadoliberin; used intranasally, causes suppression of ovulation due to reduced secretion of gonadotropic hormones caused by hyposensitivity of liberin receptors after prolonged stimulation
Daily from 400 to 600 mcg of buserelin intranasally for 3-6 months
Bleeding with long-term use of a superagonist is quite regular, menstrual-like, oligomenorrhea and amenorrhea are possible; however, dysfunctional uterine bleeding does not occur
Side effects do not appear, with the exception of disturbances in the bleeding pattern caused by anovulation. Subcutaneous implants. Levonorgestrel (norplant, nor-plant-2) is a long-acting, reversible and effective contraceptive.
Mechanism of contraceptive action: gradual release of levonorgestrel, which causes suppression of ovulation (not everyone has a change in the nature of cervical mucus (becomes more viscous), suppression of proliferative changes in the endometrium.
Contraceptive effectiveness is 0.5-1.5 pregnancies per 100 women per year.
Mode of application
Six flexible silicone rubber implants containing levonorgestrel are implanted under the skin of a woman's upper arm.
A small amount of levonorgestrel is released at a relatively constant rate over 5 years with Norplat and 3 years with Norplant-2.
Time of administration
In the first 7 days of the menstrual cycle
After a medical abortion
6-8 weeks after birth
The implant is removed under local anesthesia after its expiration date, if persistent adverse reactions develop, or at any time at the woman’s request.
Recommendations for patients
A sufficient contraceptive effect develops 24 hours after administration of the drug.
The skin wound after implantation should not be wetted until it heals.
The drug must be removed in a timely manner (after 3 or, respectively, after 5 years).
Situations that dictate the need to see a doctor:
the occurrence of an inflammatory reaction at the site of implantation
absence of menstruation or heavy uterine bleeding
pain in the lower abdomen
capsule expulsion
migraine-like headaches
visual impairment.
Indications: late reproductive age, the presence of contraindications to the use of estrogen-containing drugs, uterine fibroids up to 8 weeks of pregnancy, the need to prescribe progestogens for therapeutic purposes (fibrocystic mastopathy, hyperpolymenorrhea, algomenorrhea, ovulatory pain).
Side effect is the appearance of frequent and irregular bleeding, intermenstrual spotting or amenorrhea. If side effects do not go away after a few months, the implants must be removed.
VOLUNTARY SURGICAL STERILIZATION is the most common method of family planning. In 1990, 145 million women and 45 million men underwent surgical sterilization. The method is the most effective and economical, but provides irreversible contraception. Restoring fertility is possible, but most often difficult.
Female sterilization is the creation of a mechanical break in the fallopian tubes. Laparoscopic access is the most optimal.
Methods
Methods of ligation and division - ligation of the fallopian tubes followed by division
The mechanical method is the application of silicone rings or clamps to the fallopian tube. Advantage: Reconstructive surgeries to restore fertility are technically simpler
Coagulation method
Other methods include the introduction of special plugs and chemicals into the fallopian tubes that cause the formation of strictures.
Contraceptive effectiveness is 0.05-0.4 pregnancies per 100 women per year.
Indications
Presence of medical contraindications to pregnancy
The desire of a woman in the presence of the following conditions (according to the laws of the Russian Federation)
Age over 32 years with one child in the family
Presence of 2 or more children in the family.
Contraindications
Absolute - acute inflammatory diseases of the pelvic organs
Relative: diseases of the cardiovascular system (including the presence of arrhythmias, arterial hypertension), diseases of the respiratory system, diabetes mellitus, tumors of the pelvic organs, severe cachexia, adhesive disease, umbilical hernia. Male sterilization (vasectomy) - division of the vas deferens. The operation is relatively simple and inexpensive compared to female sterilization.
Complications: hematoma, development of inflammatory processes (most often congestive epididymitis), granuloma
The contraceptive effect is 0.1-0.5 pregnancies per 100 women per year.
Abbreviations. IUD - intrauterine device
ICD
Z30 Monitoring contraceptive useZ30.0 General advice and advice on contraception
Z30.1 Insertion of (intrauterine) contraceptive device
Z30.2 Sterilization
Z30.3 Inducing menstruation
Z30.4 Monitoring the use of contraceptive drugs
Z30.5 Monitoring the use of (intrauterine) contraceptives
Z30.8 Other type of monitoring of contraceptive use
Z30.9 Monitoring of contraceptive use, unspecified
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