Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial
Missed Abortion, Pregnancy
About this trial
This is an interventional treatment trial for Missed Abortion focused on measuring mifepristone, misoprostol, obstetrics, reproductive health, pregnancy, abortion, missed abortion
Eligibility Criteria
Inclusion Criteria:
Ultrasound examination demonstrating:
- Evidence of fetal demise (no fetal cardiac activity despite recognizable embryo and dates consistent with the likelihood of visible pregnancy) OR
- 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
Sites / Locations
- Hospital Nacional Profesor Alejandro Posadas
- CHU Libreville
- Hospital General Valle Ceylan
- Agha Khan University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Mifepristone-misoprostol regimen
Misoprostol alone regimen
After a woman is determined eligible and signs the informed consent document, she will receive 200 mg mifepristone and advised to swallow the pill when they arrive at home. 24 hours after administration of the mifepristone, women will administer the four tablets of 200 mcg misoprostol sublingually.
After a woman is determined eligible and signs the informed consent document, she will receive a placebo (of same shape and size of mifepristone) and advised to swallow the pill when they arrive at home. 24 hours after administration of the mifepristone, women will administer the four tablets of 200 mcg misoprostol sublingually.