Immediate Versus Delayed Initiation of Intrauterine System

Study Overview
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Brief Summary
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Contraception for teenagers and young adults presents a huge challenge for the clinician as more than half of all unintended pregnancies occur as a result of inconsistent or discontinued use of contraceptives . Possible solution is promoting the use of long acting reversible contraception, (LARC) among them the intrauterine device (IUD). IUD provide safe, highly effective, long-term contraception. Immediate IUD insertion after the termination of pregnancy (TOP) is a very convenient way to provide contraception as it is an opportune moment to carry out this short, easy, and safe procedure. Janess is a T-shaped intrauterine delivery system that was introduced lately, which slowly releases a small amount (13.5 mg) of levonorgestrel after its installation inside the womb and provides contraception for up to three years. The aim of this study to compare insertion of 13.5 mg levonorgestrel-releasing intrauterine system after surgical abortion immediately versus delayed insertion (at menstruation)

Detailed Description
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The rate of repeat induced abortion varies from 30% to 38% in northern Europe. Young women, parous women and those with a history of abortion were found to be the main risk factors associated with recurrent termination of pregnancy. Young women may lack knowledge or access to conventional methods of preventing pregnancy, as they may be too embarrassed or frightened to seek such information. Contraception for teenagers and young adults presents a huge challenge for the clinician as more than half of all unintended pregnancies occur as a result of inconsistent or discontinued use of contraceptives . Possible solution is promoting the use of long acting reversible contraception, (LARC) among them the intrauterine device (IUD), that was found well suited even for adolescents. Because IUDs do not require active use once they have been inserted, and have a very low failure rate, their increased use has the potential to substantially reduce unintended pregnancies. IUD provide safe, highly effective, long-term contraception, but they are underused. Immediate initiation of any contraceptive method after an abortion has been linked to a reduced risk of repeat abortion. Immediate IUD insertion after the termination of pregnancy (TOP) is a very convenient way to provide contraception as it is an opportune moment to carry out this short, easy, and safe procedure. As the cervix is dilated, insertion is virtually painless. Following insertion, the woman is protected immediately, before ovulation returns, usually within 7-10 days after first-trimester abortion. Lately, a new intrauterine device directed for young women was introduced. It is a T-shaped intrauterine delivery system which slowly releases a small amount (13.5 mg) of levonorgestrel after its installation inside the womb. The system is intended for contraception for a period of up to 3 years. It works by reducing the monthly growth of the lining of the womb and thickening of the cervical mucosal layer. To the best of the investigator's knowledge this is the first study to compare insertion of 13.5 mg levonorgestrel-releasing intrauterine system after surgical abortion immediately versus delayed insertion (at menstruation) .

Official Title
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Immediate Versus Delayed Initiation of the 13.5 mg Levonorgestrel-releasing Intrauterine System Following Surgical Termination of Pregnancy

Conditions
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Contraception

Intervention / Treatment
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* Device: Intrauterine system
* Other: Alternative contraception to intrauterine system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women that are about to go through surgical termination of first trimester pregnancy Age ≥ 18 years Nulliparous Exclusion Criteria: structural uterine abnormality submucosal fibroids suspected uterine or cervical neoplasia acute pelvic inflammatory disease acute liver disease or previous breast cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate insertion<br>The intrauterine system will be inserted immediately after surgical termination of pregnancy, before awakening from anesthesia | Device: Intrauterine system<br>* 13.5 mg levonorgestrel-releasing intrauterine system<br>* Other names: Janess;|
| Experimental: Delayed insertion<br>The intrauterine system will be inserted on the first menstruation after termination of pregnancy. Women allocated to this arm will be asked to contact the study coordinator in order to visit the hospital on the proper timing for IUD insertion. | Device: Intrauterine system<br>* 13.5 mg levonorgestrel-releasing intrauterine system<br>* Other names: Janess;|
| Other: Control<br>Women who refuse to actively participate in the intervention groups will be offered consultation on other options for contraception during gynecological clinic visit after fist menstruation from termination of pregnancy. | Other: Alternative contraception to intrauterine system<br>* Alternative contraception including contraception pills, hormonal patches, hormonal vaginal , condomsring,<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuation rate after one year from insertion |  | estimated time of one year follow up from insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expulsion rate |  | On first visit after menstruation from insertion, 3 month from insertion and after one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IUD, contraception, levonogestral