Gemeprost Versus Dinoprostone in First Trimester Miscarriages

NCT ID: NCT05342467

Last Updated: 2025-06-11

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-11

Study Completion Date

2024-10-28

Brief Summary

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Comparison between gemeprost and dinoprostone to evacuate first trimester miscarriages.

Detailed Description

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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.

Conditions

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Missed Abortion Medical; Abortion, Fetus Incomplete Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Comparison between intravaginal gemeprost and dinoprostone.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gemeprost

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

Group Type ACTIVE_COMPARATOR

Gemeprost 1 Mg Vaginal Pessary

Intervention Type DRUG

Intravaginal gemeprost 1 mg inserted 3 hourly for maximum of 5 doses in 24 hours

Dinoprostone 3 mg

Intervention Type DRUG

Intravaginal dinoprostone 3 mg inserted 4 hourly for maximum of 3 doses in 24 hours

Dinoprostone

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

Group Type ACTIVE_COMPARATOR

Gemeprost 1 Mg Vaginal Pessary

Intervention Type DRUG

Intravaginal gemeprost 1 mg inserted 3 hourly for maximum of 5 doses in 24 hours

Dinoprostone 3 mg

Intervention Type DRUG

Intravaginal dinoprostone 3 mg inserted 4 hourly for maximum of 3 doses in 24 hours

Interventions

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Gemeprost 1 Mg Vaginal Pessary

Intravaginal gemeprost 1 mg inserted 3 hourly for maximum of 5 doses in 24 hours

Intervention Type DRUG

Dinoprostone 3 mg

Intravaginal dinoprostone 3 mg inserted 4 hourly for maximum of 3 doses in 24 hours

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National University of Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rahana Abd Rahman

Role: PRINCIPAL_INVESTIGATOR

National University of Malaysia

Locations

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UKM Medical Center

Kuala Lumpur, W.Persekutuan, Malaysia

Site Status

UKM Medical Centre

Kuala Lumpur, W.Persekutuan, Malaysia

Site Status

Countries

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Malaysia

Other Identifiers

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FF-2021-504

Identifier Type: -

Identifier Source: org_study_id

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