Immediate Versus Delayed Initiation of Intrauterine System (JANESS)

Sheba Medical Center

Status: Withdrawn

Conditions: Contraception

Treatments: Device: Intrauterine system; Other: Alternative contraception to intrauterine system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03708809

4671-17-SMC

Details and patient eligibility

About

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)

Full description

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) .

Sex: Female

Ages: 18 to 42 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Immediate insertion

Experimental group

Description:

The intrauterine system will be inserted immediately after surgical termination of pregnancy, before awakening from anesthesia

Treatment:

Device: Intrauterine system

Delayed insertion

Experimental group

Description:

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.

Treatment:

Device: Intrauterine system

Control

Other group

Description:

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.

Treatment:

Other: Alternative contraception to intrauterine system