Gemeprost Versus Dinoprostone in First Trimester Miscarriages

Phase 2

Recruiting

• Conditions: Incomplete Abortion; Missed Abortion; Medical; Abortion, Fetus
• Interventions: Drug: Gemeprost 1 Mg Vaginal Pessary; Drug: Dinoprostone 3 mg

• Registration Number: NCT05342467
• Lead Sponsor: National University of Malaysia

Brief Summary

Comparison between gemeprost and dinoprostone to evacuate first trimester miscarriages.

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 Timeline

• Study Start: 2021-11-11
• Study First Submitted: 2022-04-17
• Study First Submitted QC: 2022-04-17
• Study First Posted: 2022-04-22
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23
• Primary Completion: 2025-11-10
• Study Completion: 2025-11-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 174

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dinoprostone	Gemeprost 1 Mg Vaginal Pessary	Dinoprostone 3 mg inserted 4 hourly for maximum of 3 doses in 24 hours.
Dinoprostone	Dinoprostone 3 mg	Dinoprostone 3 mg inserted 4 hourly for maximum of 3 doses in 24 hours.
Gemeprost	Gemeprost 1 Mg Vaginal Pessary	Gemeprost 1 mg inserted 3 hourly for maximum of 5 doses in 24 hours.
Gemeprost	Dinoprostone 3 mg	Gemeprost 1 mg inserted 3 hourly for maximum of 5 doses in 24 hours.

Primary Outcome Measures

Name	Time	Method
Percentage of women who achieved complete evacuation	from recruitment until up to one week after commencement of treatment	Complete expulsion of product of conception

Secondary Outcome Measures

Name	Time	Method
Percentage of women who experienced side effects	from recruitment until up to one week after commencement of treatment	side effects towards each drug such as fever, gastrointestinal upset

Trial Locations

Locations (2)

UKM Medical Centre; 🇲🇾 Kuala Lumpur, W.Persekutuan, Malaysia

UKM Medical Center; 🇲🇾 Kuala Lumpur, W.Persekutuan, Malaysia