Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial

Phase 4

Terminated

• Conditions: Pregnancy; Missed Abortion
• Interventions: Drug: Mifepristone; Drug: Misoprostol

• Registration Number: NCT02342002
• Lead Sponsor: Gynuity Health Projects

Brief Summary

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.

Detailed Description

The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of missed abortion. This will be a randomized controlled double-blinded trial of 416 women comparing misoprostol alone to mifepristone plus misoprostol for treatment of missed abortion less than 13 weeks+ 0 days LMP. All women in the trial will undergo routine screening (including ultrasound) and pre-medical induction care per standard practice at the hospital. All eligible women agreeing to participate in the study will be randomized to receive one of the following regimens: 1) STUDY GROUP ONE: 200mg mifepristone followed in 24 hours by 800mcg sublingual misoprostol; 2) STUDY GROUP TWO: placebo followed in 24 hours by 800mcg sublingual misoprostol.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-09
• Study First Submitted QC: 2015-01-14
• Study First Posted: 2015-01-19
• Status Verified: 2018-11
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Last Update Submitted: 2019-01-11
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 416

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mifepristone-misoprostol regimen	Misoprostol	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.
Mifepristone-misoprostol regimen	Mifepristone	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.
Misoprostol alone regimen	Misoprostol	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.

Primary Outcome Measures

Name	Time	Method
Rate of successful evacuation of the uterus	1 week after treatment	uterine evacuation without the need for uterine aspiration or other surgery

Secondary Outcome Measures

Name	Time	Method
Induction expulsion interval after misoprostol administration	one week follow-up	time interval between misoprostol administration and the expulsion
Acceptability of assigned method to women	one week follow-up
Rate of successful evacuation without any additional intervention	1 week after treatment	uterine evacuation without the need for vacuum aspiration, additional uterotonics or other intervention
Excessive bleeding or a complication for which a woman received treatment	30 days after treatment

Trial Locations

Locations (4)

Hospital Nacional Profesor Alejandro Posadas; 🇦🇷 Buenos Aires, Argentina

CHU Libreville; 🇬🇦 Libreville, Gabon

Hospital General Valle Ceylan; 🇲🇽 Tlalnepantla, Mexico

Agha Khan University Hospital; 🇵🇰 Karachi, Pakistan