Misoprostol for Treatment of Fetal Death at 14-28 Weeks of Pregnancy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the proposed study is to test - in a randomized, blinded trial - two different doses of the prostaglandin E1 analogue misoprostol administered buccally as a treatment for fetal death at 14 - 28 weeks, inclusive, of pregnancy. At such an advanced stage of pregnancy, the nonviable fetus is often not spontaneously evacuated, and yet timely evacuation is vital in order to avoid the possibility of, among other things, potentially life-threatening maternal coagulopathies. Current approaches to uterine evacuation in these cases include dilatation and evacuation (D\&E) surgery (in less advanced pregnancies) and labor induction with a variety of products. Misoprostol has been demonstrated to be as effective as, or more effective than, either oxytocin or prostaglandin E2 analogues for this indication in a number of small, non-FDA-approved trials which have been published in the peer-reviewed literature. In the absence of more formal study of this treatment, however, dosages are not standardized, pathways of administration vary, and other uncertainties linger. The purpose of the protocol proposed herein is to formally establish, via a randomized, double-blinded study, the safety and effectiveness of misoprostol for this indication, and to compare the value of two distinct doses, so that providers may henceforward proceed with greater authority and confidence.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02633761

Fetal Death

TERMINATED PHASE3

MisOpRostol Effect on Second Trimester Abortion Blood Loss

NCT06078501

Blood Loss, Surgical Second Trimester Abortion

TERMINATED PHASE3

Mifepristone Induction for Fetal Demise

NCT02620904

Intrauterine Fetal Demise Fetal Death

TERMINATED PHASE4

Misoprostol 400 µg Versus 200 µg for Cervical Ripening in 1st Trimester Miscarriage

NCT02957305

Miscarriage in First Trimester

COMPLETED PHASE4

Misoprostol for Management of Women With an Incomplete Miscarriage

NCT05088720

Miscarriage

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intrauterine Fetal Demise

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

2

Women in Group 1 will be administered two tablets (2 100 mcg misoprostol tablets), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

200 mcg buccal misoprostol administered every 6 hours for up to 48 hours until fetus is delivered.

1

Women in Group 1 will be administered two tablets (a 100 mcg misoprostol tablet and a placebo tablet made to resemble a 100 mcg misoprostol tablet), which she will be instructed to hold in her cheeks for 200 minutes, after which she will swallow any medication that remains. In cases where cervical dilation is not complete after six hours, women will be given a second dose of study drug. Study drug will continue to be administered at 6-hourly intervals through hour 42 after the study dose.

Group Type PLACEBO_COMPARATOR

Misoprostol

Intervention Type DRUG

100 mcg buccal misoprostol administered every 6 hours for upto 48 hours

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Misoprostol

200 mcg buccal misoprostol administered every 6 hours for up to 48 hours until fetus is delivered.

Intervention Type DRUG

Misoprostol

100 mcg buccal misoprostol administered every 6 hours for upto 48 hours

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Women presents with spontaneous fetal death
* Gestational age of fetus between 14-28 weeks

Exclusion Criteria

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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No