Use of Misoprostol in Case of Insertion Failure of Intrauterine Contraceptives
Assessment of Use of Misoprostol to Facilitate the Insertion of Intrauterine Contraceptives After Failure of Insertion. A Randomized Double-blind Clinical Trial
1 other identifier
interventional
102
1 country
2
Brief Summary
To assess the usefulnes sof misoprostol versus placebo (in a double-blind placebo controlled randomized clinical trial)to facilitate the insertion of copper-IUD and the levonorgestrel-releasing intrauterine system (LNG-IUS) in cases of failure due to cervical stenosis in either nulligravidas and parous women. Additionally to evaluate the side-effects of the misoprostol. The hypothesis is that misoprostol may be better than placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2013
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2012
CompletedFirst Posted
Study publicly available on registry
December 21, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJune 4, 2015
June 1, 2015
1.9 years
December 18, 2012
June 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ease of insertion of intrauterine contraceptives
The study group will receive two doses of misoprostol (200mcg each tablet) vaginal 12 and 4 hours prior insertion and the control group will receive placebo in the same schedule. The sample will be 50 women in each group. After 24 hours of the insertion failure the women will return to the clinic and a new attempt of insertion will be done. At this time we will evaluate if the insertion was able to do or not.
12 months
Secondary Outcomes (1)
Side-effects of misoprostol
12 months
Study Arms (2)
misoprostol vaginal 200 mcg
ACTIVE COMPARATORThe study group will receive two doses of misoprostol (200mcg each tablet) vaginal 12 and 4 hours prior insertion After 24 hours of the insertion failure the women will return to the clinic and a new attempt of insertion will be done. At this time we will evaluate if the insertion was able to do or not.
placebo
PLACEBO COMPARATORThe placebo group will receive two doses of placebo vaginal 12 and 4 hours prior insertion. After 24 hours of the insertion failure the women will return to the clinic and a new attempt of insertion will be done. At this time we will evaluate if the insertion was able to do or not.
Interventions
The study group will receive two doses of misoprostol (200mcg each tablet) vaginal 12 and 4 hours prior insertion. After 24 hours of the insertion failure the women will return to the clinic and a new attempt of insertion will be done. At this time we will evaluate if the insertion was able to do or not.
Eligibility Criteria
You may qualify if:
- Women aged \> 18 and \<50 years old; Requesting insertion of and IUD or an LNG-IUS Failure of IUD insertion
You may not qualify if:
- Refuse to participate Lost to follow-up at the return visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Luis Bahamondeslead
Study Sites (2)
Family Planning Clinic, University of Campinas
Campinas, São Paulo, 13084-971, Brazil
University of Campinas
Campinas, São Paulo, Brazil
Related Publications (1)
Bahamondes MV, Espejo-Arce X, Bahamondes L. Effect of vaginal administration of misoprostol before intrauterine contraceptive insertion following previous insertion failure: a double blind RCT. Hum Reprod. 2015 Aug;30(8):1861-6. doi: 10.1093/humrep/dev137. Epub 2015 Jun 3.
PMID: 26040478DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
December 18, 2012
First Posted
December 21, 2012
Study Start
January 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
June 4, 2015
Record last verified: 2015-06