Gemeprost Versus Dinoprostone in First Trimester Miscarriages

January 22, 2024 updated by: National University of Malaysia

Gemeprost Versus Dinoprostone in the Medical Management of First Trimester Miscarriages: a Randomized Controlled Study

Comparison between gemeprost and dinoprostone to evacuate first trimester miscarriages.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Women who are diagnosed with first trimester missed miscarriages are invited to participate in the study. They will be randomised to either gemeprost or dinoprostone.

Study Type

Interventional

Enrollment (Estimated)

174

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • missed miscarriages
  • incomplete miscarriages
  • first trimester

Exclusion Criteria:

  • coagulopathy
  • Rhesus negative
  • suspected ectopic pregnancy or pregnancy of unknown location
  • on anticoagulation drug
  • septic miscarriages
  • hemodynamically unstable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Gemeprost
Gemeprost 1 mg inserted 3 hourly for maximum of 5 doses in 24 hours.
Drug: Gemeprost 1 Mg Vaginal Pessary
Intravaginal gemeprost 1 mg inserted 3 hourly for maximum of 5 doses in 24 hours
Drug: Dinoprostone 3 mg
Intravaginal dinoprostone 3 mg inserted 4 hourly for maximum of 3 doses in 24 hours
Active Comparator: Dinoprostone
Dinoprostone 3 mg inserted 4 hourly for maximum of 3 doses in 24 hours.
Drug: Gemeprost 1 Mg Vaginal Pessary
Intravaginal gemeprost 1 mg inserted 3 hourly for maximum of 5 doses in 24 hours
Drug: Dinoprostone 3 mg
Intravaginal dinoprostone 3 mg inserted 4 hourly for maximum of 3 doses in 24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of women who achieved complete evacuation
Time Frame: from recruitment until up to one week after commencement of treatment
Complete expulsion of product of conception
from recruitment until up to one week after commencement of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of women who experienced side effects
Time Frame: from recruitment until up to one week after commencement of treatment
side effects towards each drug such as fever, gastrointestinal upset
from recruitment until up to one week after commencement of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Malaysia

Investigators

  • Principal Investigator: Rahana Abd Rahman, National University of Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2021

Primary Completion (Estimated)

November 10, 2025

Study Completion (Estimated)

November 10, 2025

Study Registration Dates

First Submitted

April 17, 2022

First Submitted That Met QC Criteria

April 17, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FF-2021-504

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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