Comparison of Single and Repeated Dose of Vaginal Misoprostol for the Treatment of Early Pregnancy Failure

NCT ID: NCT02515604

Last Updated: 2016-11-01

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

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-07-31

Brief Summary

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

A randomised controlled trial assessing the efficacy of single versus repeated dose of vaginal misoprostol for the treatment of early pregnancy failure.

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.

Abortion, Missed

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

SINGLE

Outcome Assessors

Study Groups

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

Single dose group

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

Repeated dose group

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

Interventions

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

Misoprostol

Intervention Type DRUG

Other Intervention Names

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

Cytotec

Eligibility Criteria

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

Inclusion Criteria

* Women with early pregnancy failure, defined as missed abortion or blighted ovum, seeking medical treatment with misoprostol.
* Age equal or greater than 18 years
* Gestational age less than 12 complete weeks.

Exclusion Criteria

* Complete, incomplete, inevitable, or septic abortion.
* Hemodynamically unstable patients.
* Misoprostol sensitivity or contraindication.
* Multifetal pregnancies.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yossi Mizrachi

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yossi Mizrachi, MD

Role: PRINCIPAL_INVESTIGATOR

Wolfson Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wolfson Medical Center

Holon, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

References

Explore related publications, articles, or registry entries linked to this study.

Mizrachi Y, Dekalo A, Gluck O, Miremberg H, Dafna L, Feldstein O, Weiner E, Bar J, Sagiv R. Single versus repeat doses of misoprostol for treatment of early pregnancy loss-a randomized clinical trial. Hum Reprod. 2017 Jun 1;32(6):1202-1207. doi: 10.1093/humrep/dex074.

Reference Type DERIVED
PMID: 28402415 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0104-15-WOMC

Identifier Type: -

Identifier Source: org_study_id