Clinical trial NCT02342002: Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial
Official title: Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Missed Abortion
Pregnancy
Keywords: mifepristone
misoprostol
obstetrics
reproductive health
pregnancy
abortion
missed abortion
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2015-01-19
Enrollment: 416
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of successful evacuation of the uterus
timeFrame: 1 week after treatment
Secondary outcomes:
measure: Rate of successful evacuation without any additional intervention
timeFrame: 1 week after treatment
measure: Excessive bleeding or a complication for which a woman received treatment
timeFrame: 30 days after treatment
measure: Induction expulsion interval after misoprostol administration
timeFrame: one week follow-up
measure: Acceptability of assigned method to women
timeFrame: one week follow-up
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Nacional Profesor Alejandro Posadas
city: Libreville
country: Gabon
facility: CHU Libreville
city: Tlalnepantla
country: Mexico
facility: Hospital General Valle Ceylan
city: Karachi
country: Pakistan
facility: Agha Khan University Hospital
Study officials:
affiliation: Gynuity Health Projects
name: Hillary Bracken, PhD
role: PRINCIPAL_INVESTIGATOR
References: