Pregnancy Clinical Trial
Official title:
Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial
Verified date | November 2018 |
Source | Gynuity Health Projects |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the proposed study is to compare - in a randomized, placebo-controlled, double-blinded trial - a combination of mifepristone and misoprostol to misoprostol used alone for missed abortion.
Status | Terminated |
Enrollment | 416 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 49 Years |
Eligibility |
Inclusion Criteria: - Ultrasound examination demonstrating: 1. Evidence of fetal demise (no fetal cardiac activity despite recognizable embryo and dates consistent with the likelihood of visible pregnancy) OR 2. Empty gestational sac with no evidence of incomplete abortion or growth over a 7-day period confirmed by two ultrasounds performed one week apart. - If fetus exists, fetal size less than 12 weeks+6 days - Closed cervical os - Eligible to consent for research according to local regulations Exclusion Criteria: - Active bleeding at enrollment and/or history of bleeding within the prior week - Allergies or other contraindications to the use of mifepristone or misoprostol - Suspected ectopic pregnancy - History of trophoblastic disease - Coagulation disorder and/or currently taking anticoagulants - Any serious medical condition |
Country | Name | City | State |
---|---|---|---|
Argentina | Hospital Nacional Profesor Alejandro Posadas | Buenos Aires | |
Gabon | CHU Libreville | Libreville | |
Mexico | Hospital General Valle Ceylan | Tlalnepantla | |
Pakistan | Agha Khan University Hospital | Karachi |
Lead Sponsor | Collaborator |
---|---|
Gynuity Health Projects |
Argentina, Gabon, Mexico, Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of successful evacuation of the uterus | uterine evacuation without the need for uterine aspiration or other surgery | 1 week after treatment | |
Secondary | Rate of successful evacuation without any additional intervention | uterine evacuation without the need for vacuum aspiration, additional uterotonics or other intervention | 1 week after treatment | |
Secondary | Excessive bleeding or a complication for which a woman received treatment | 30 days after treatment | ||
Secondary | Induction expulsion interval after misoprostol administration | time interval between misoprostol administration and the expulsion | one week follow-up | |
Secondary | Acceptability of assigned method to women | one week follow-up |
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