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

Phase 4TerminatedNCT02342002

Gynuity Health Projects416 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

416

Conditions

Missed Abortion Pregnancy

Interventions

MifepristoneDRUG

Mifepristone for treatment of missed abortion

MisoprostolDRUG

Misoprostol for treatment of missed abortion

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Rate of successful evacuation of the uterus

uterine evacuation without the need for uterine aspiration or other surgery

Time frame: 1 week after treatment

Secondary Outcomes

Rate of successful evacuation without any additional intervention

uterine evacuation without the need for vacuum aspiration, additional uterotonics or other intervention

Time frame: 1 week after treatment

Excessive bleeding or a complication for which a woman received treatment

Time frame: 30 days after treatment

Induction expulsion interval after misoprostol administration

time interval between misoprostol administration and the expulsion

Time frame: one week follow-up

Acceptability of assigned method to women

Time frame: one week follow-up

Data from ClinicalTrials.gov

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