Mifepristone and Misoprostol for Fetal Demise

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

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

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-09-30

Brief Summary

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

This is a pilot clinical trial to evaluate whether the medical management of early pregnancy failure with mifepristone and misoprostol is an effective and acceptable treatment. Subjects with early pregnancy failure receive mifepristone followed 24 hours later by vaginal misoprostol for medical management. Subjects then return on study day 3 for a repeat ultrasound to assess passage of pregnancy tissue. subjects who still have a gestational sac present at Day 3 receive a second dose of vaginal misoprostol. All subjects have a follow-up at Day 15, by phone for those who passed the pregnancy with the first dose of misoprostol, and in person for those who received a second dose. Questionnaires are administered at the beginning and end of the study to determine acceptability.

Related Clinical Trials

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

Mifepristone and Misoprostol Versus Misoprostol Alone in the Medical Management of Missed Miscarriage

NCT03065660

Missed Miscarriage

COMPLETED PHASE3

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

NCT02633761

Fetal Death

TERMINATED PHASE3

Comparative Effectiveness of Pregnancy Failure Management Regimens

NCT02012491

Spontaneous Abortion

COMPLETED PHASE3

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

NCT02342002

Missed Abortion Pregnancy

TERMINATED PHASE4

Mifepristone Induction for Fetal Demise

NCT02620904

Intrauterine Fetal Demise Fetal Death

TERMINATED PHASE4

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.

Anembryonic Pregnancy Gestation Abnormality Intrauterine Fetal Demise Term

Study Design

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

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

1

Mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally

Group Type EXPERIMENTAL

mifepristone/misoprostol

Intervention Type DRUG

mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally

Interventions

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

mifepristone/misoprostol

mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Mifeprix/Cytotec

Eligibility Criteria

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

Inclusion Criteria

\-

Exclusion Criteria

* orthostatic hypotension, contraindication to either mifepristone or misoprostol, treatment during current pregnancy to provide surgical or medical evacuation of the uterus, evidence of ovarian hyperstimulation syndrome, known or suspected pelvic infection,known or suspected clotting defect or receiving anticoagulants, cardiovascular disease, current breastfeeding, pregnancy with and IUD in situ, current participation in another clinical trial, prior participation in this trial, suspected or confirmed endometrial AV malformation, clinical indication requiring the karyotyping of products of conception

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes