Gemeprost Versus Dinoprostone in First Trimester Miscarriages

Sponsor

National University of Malaysia (Other)

Overall Status

Recruiting

CT.gov ID

NCT05342467

Collaborator

(none)

174

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Comparison between gemeprost and dinoprostone to evacuate first trimester miscarriages.

Condition or Disease	Intervention/Treatment	Phase
Missed Abortion Medical; Abortion, Fetus Incomplete Abortion	Drug: Gemeprost 1 Mg Vaginal Pessary Drug: Dinoprostone 3 mg	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

174 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Comparison between intravaginal gemeprost and dinoprostone.Comparison between intravaginal gemeprost and dinoprostone.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 11, 2021

Anticipated Primary Completion Date :

Nov 10, 2023

Anticipated Study Completion Date :

Nov 10, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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 Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UKM Medical Center	Kuala Lumpur	W.Persekutuan	Malaysia	56000
2	UKM Medical Centre	Kuala Lumpur	W.Persekutuan	Malaysia	56000

Sponsors and Collaborators

National University of Malaysia

Investigators

Principal Investigator: Rahana Abd Rahman, National University of Malaysia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National University of Malaysia

ClinicalTrials.gov Identifier:

NCT05342467

Other Study ID Numbers:

FF-2021-504

First Posted:

Apr 22, 2022

Last Update Posted:

May 2, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by National University of Malaysia

miscarriages

first trimester

medical treatment

Additional relevant MeSH terms:

Abortion, Spontaneous

Study Results

No Results Posted as of May 2, 2022