Study Stopped
could not be funded
Immediate Versus Delayed Initiation of Intrauterine System
JANESS
1 other identifier
interventional
N/A
1 country
1
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2018
CompletedFirst Posted
Study publicly available on registry
October 17, 2018
CompletedStudy Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
November 14, 2024
November 1, 2024
2.7 years
October 14, 2018
November 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Continuation rate after one year from insertion
estimated time of one year follow up from insertion
Secondary Outcomes (1)
Expulsion rate
On first visit after menstruation from insertion, 3 month from insertion and after one year
Study Arms (3)
Immediate insertion
EXPERIMENTALThe intrauterine system will be inserted immediately after surgical termination of pregnancy, before awakening from anesthesia
Delayed insertion
EXPERIMENTALThe 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.
Control
OTHERWomen 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.
Interventions
13.5 mg levonorgestrel-releasing intrauterine system
Alternative contraception including contraception pills, hormonal patches, hormonal vaginal , condomsring,
Eligibility Criteria
You may qualify if:
- Women that are about to go through surgical termination of first trimester pregnancy
- Age ≥ 18 years
- Nulliparous
You may not qualify if:
- structural uterine abnormality
- submucosal fibroids
- suspected uterine or cervical neoplasia
- acute pelvic inflammatory disease
- acute liver disease or previous breast cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sheba Medical Centerlead
- Bayercollaborator
Study Sites (1)
Sheba Medical Center
Ramat Gan, Israel
Related Publications (5)
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.
PMID: 18672117RESULTApter 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.
PMID: 29032945RESULTHubacher 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.
PMID: 15157788RESULTGoodman 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.
PMID: 18672116RESULTLahteenmaki 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.
PMID: 630723RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Aya Mohr Sasson, M.D
Sheba Medical Center, Tel-Hashomer
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 14, 2018
First Posted
October 17, 2018
Study Start
December 1, 2023
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
November 14, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share