Mifepristone-misoprostol vs. Misoprostol Alone for Second Trimester Fetal Death

Mifepristone and Misoprostol Versus Misoprostol Alone for Treatment of Fetal Death at 14-28 Weeks of Pregnancy: A Randomized, Placebo-controlled Double-blinded Trial

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02633761

Enrollment

200

Registered

2015-12-17

Start date

2015-04-01

Completion date

2018-12-30

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Death

Keywords

Fetal death, mifepristone, misoprostol

Brief summary

The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of intrauterine fetal demise between 14 and 28 weeks LMP.

Detailed description

The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of intrauterine fetal demise between 14 and 28 weeks LMP. This will be a randomized controlled double-blinded trial of 150 women comparing misoprostol alone to mifepristone plus misoprostol for evacuation of the uterus after fetal demise in the second and third trimester. All women in the trial will undergo routine screening 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 repeated doses of 200mcg buccal misoprostol given every 3 hours; 2. STUDY GROUP TWO: placebo followed in 24 hours by 200mcg buccal misoprostol given every three hours.

Interventions

DRUGMifepristone

200mg mifepristone followed in 24 hours by 200mcg buccal misoprostol every 3 hours.

DRUGPlacebo

placebo followed in 24 hours by 200mcg buccal misoprostol every 3 hours.

DRUGMisoprostol 200mcg

Buccal misoprostol 200mcg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 64 Years

Healthy volunteers

Yes

Inclusion criteria

* Demised fetus of between 14 to 28 weeks duration confirmed by ultrasound * Have no contraindications to study procedure, according to provider * Be able to consent to procedure, either by reading consent document or by having consent document read to her * Be willing to follow study procedures.

Exclusion criteria

* Allergies or other contraindications to the use of mifepristone or misoprostol; * Placental abruption with active hemorrhage, * Complete placenta previa, extreme uterine structural anomalies, or other contradictions to vaginal delivery of the fetus; * Presentation in active labor (moderate to severe contractions every 10 minutes or less); * Transmural uterine scars; * Four or more previous deliveries.

Design outcomes

Primary

Measure	Time frame	Description
Complete uterine evacuation of the fetus and placenta without surgical intervention	48 hours	Complete uterine evacuation of fetus and placenta using study drug alone without recourse to any additional surgical intervention

Countries

Mexico, Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026