Gemeprost Versus Dinoprostone in First Trimester Miscarriages

National University of Malaysia

Status and phase: Enrolling; Phase 2

Conditions: Medical; Abortion, Fetus; Incomplete Abortion; Missed Abortion

Treatments: Drug: Gemeprost 1 Mg Vaginal Pessary; Drug: Dinoprostone 3 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05342467

FF-2021-504

Details and patient eligibility

About

Comparison between gemeprost and dinoprostone to evacuate first trimester miscarriages.

Full 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.

Enrollment: 174 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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174 participants in 2 patient groups

Gemeprost

Active Comparator group

Description:

Gemeprost 1 mg inserted 3 hourly for maximum of 5 doses in 24 hours.

Treatment:

Drug: Dinoprostone 3 mg

Drug: Gemeprost 1 Mg Vaginal Pessary

Dinoprostone

Active Comparator group

Description:

Dinoprostone 3 mg inserted 4 hourly for maximum of 3 doses in 24 hours.

Treatment:

Drug: Dinoprostone 3 mg

Drug: Gemeprost 1 Mg Vaginal Pessary