Gemeprost Versus Dinoprostone in First Trimester Miscarriages

NCT05342467 — Phase 2, Completed, 101 participants, National University of Malaysia

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

Registry	NCT05342467
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	101 (Actual)
Sponsor	National University of Malaysia (Other)
Conditions	Missed Abortion, Medical; Abortion, Fetus, Incomplete Abortion
Interventions	Gemeprost 1 Mg Vaginal Pessary, Dinoprostone 3 mg (Drug)
Dates	start 2022-11-11, primary completion 2024-10-28, completion 2024-10-28, first posted 2022-04-22, last updated 2025-06-11
Locations	2 sites in Malaysia

-Summary

Comparison between gemeprost and dinoprostone to evacuate first trimester miscarriages.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Gemeprost	Active comparator	Drug: Gemeprost 1 Mg Vaginal Pessary; Drug: Dinoprostone 3 mg	Gemeprost 1 mg inserted 3 hourly for maximum of 5 doses in 24 hours.
Dinoprostone	Active comparator	Drug: Gemeprost 1 Mg Vaginal Pessary; Drug: Dinoprostone 3 mg	Dinoprostone 3 mg inserted 4 hourly for maximum of 3 doses in 24 hours.

Gemeprost 1 Mg Vaginal Pessary (Drug): Intravaginal gemeprost 1 mg inserted 3 hourly for maximum of 5 doses in 24 hours
Dinoprostone 3 mg (Drug): Intravaginal dinoprostone 3 mg inserted 4 hourly for maximum of 3 doses in 24 hours

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: Female, ages: 18 Years to 50 Years, 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

+Locations (2)

Facility	City	Country	Status
UKM Medical Center	Kuala Lumpur, W.Persekutuan	Malaysia
UKM Medical Centre	Kuala Lumpur, W.Persekutuan	Malaysia

+Investigators

Rahana Abd Rahman, Principal investigator, National University of Malaysia

My Notes

Public

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