Immediate Versus Delayed Initiation of Intrauterine System

Contraception Clinical Trial

— JANESS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03708809
• Other study ID #: 4671-17-SMC
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: August 1, 2026

Study information

• Verified date: June 2023
• Source: Sheba Medical Center
• Contact: Aya Mohr Sasson, M.D
• Phone: 0523692906
• Email: mohraya[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

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) .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 270
• Est. completion date: August 1, 2026
• Est. primary completion date: August 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Device:
• Intrauterine system
13.5 mg levonorgestrel-releasing intrauterine system

Other:
• Alternative contraception to intrauterine system
Alternative contraception including contraception pills, hormonal patches, hormonal vaginal , condomsring,

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	Bayer

Country where clinical trial is conducted

Israel, 

References & Publications (5)

Apter D. Contraception options: Aspects unique to adolescent and young adult. Best Pract Res Clin Obstet Gynaecol. 2018 Apr;48:115-127. doi: 10.1016/j.bpobgyn.2017.09.010. Epub 2017 Sep 28. — View Citation

Goodman S, Hendlish SK, Reeves MF, Foster-Rosales A. Impact of immediate postabortal insertion of intrauterine contraception on repeat abortion. Contraception. 2008 Aug;78(2):143-8. doi: 10.1016/j.contraception.2008.03.003. Epub 2008 May 14. — View Citation

Heikinheimo O, Gissler M, Suhonen S. Age, parity, history of abortion and contraceptive choices affect the risk of repeat abortion. Contraception. 2008 Aug;78(2):149-54. doi: 10.1016/j.contraception.2008.03.013. Epub 2008 May 27. — View Citation

Hubacher D, Cheng D. Intrauterine devices and reproductive health: American women in feast and famine. Contraception. 2004 Jun;69(6):437-46. doi: 10.1016/j.contraception.2004.01.009. — View Citation

Lahteenmaki P, Luukkainen T. Return of ovarian function after abortion. Clin Endocrinol (Oxf). 1978 Feb;8(2):123-32. doi: 10.1111/j.1365-2265.1978.tb02160.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuation rate after one year from insertion		estimated time of one year follow up from insertion
Secondary	Expulsion rate		On first visit after menstruation from insertion, 3 month from insertion and after one year