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NCT05342467 Clinical Trial

Gemeprost Versus Dinoprostone in First Trimester Miscarriages

Missed Abortion Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05342467
Other study ID # FF-2021-504
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date November 11, 2021
Est. completion date November 10, 2025

Study information
Verified date January 2024
Source National University of Malaysia
Contact Rahana Abd Rahman
Phone +60122719985
Email drrahana@ppukm.ukm.edu.my
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Comparison between gemeprost and dinoprostone to evacuate first trimester miscarriages.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 174
Est. completion date November 10, 2025
Est. primary completion date November 10, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Malaysia UKM Medical Center Kuala Lumpur W.Persekutuan
Malaysia UKM Medical Centre Kuala Lumpur W.Persekutuan

Sponsors (1)
Lead Sponsor Collaborator
National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of women who achieved complete evacuation Complete expulsion of product of conception from recruitment until up to one week after commencement of treatment
Secondary Percentage of women who experienced side effects side effects towards each drug such as fever, gastrointestinal upset from recruitment until up to one week after commencement of treatment
See also
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Recruiting NCT03628625 - Letrozole Pretreatment With Misoprostol fInduction of Abortion In First-Trimester Missed Miscarriage Phase 2
Completed NCT03584698 - Evening Primrose Oil to Misoprostol During Induction of Second-trimester Missed Miscarriage Phase 4
Active, not recruiting NCT05516810 - The Accuracy of Ultrasound Diagnosis of Hydatidiform Moles
Not yet recruiting NCT04590482 - Letrozole Pretreatment With Misoprostol Induction of Abortion in First Trimester Missed Abortion Phase 4
Recruiting NCT03698734 - Evening Primrose Oil Efficacy in Second Trimester Abortion Phase 3
Terminated NCT01615224 - Repeated Doses of Misoprostol for Medical Treatment of Missed Miscarriage Phase 2/Phase 3
Completed NCT05216952 - Ulipristal Acetate for Use in Early Pregnancy Loss Phase 2
Recruiting NCT03081104 - Operative Hysteroscopy and Ultrasound Guided Vacuum Aspiration Versus Blind Vacuum Aspiration for the Treatment of Missed Abortion N/A
Completed NCT00892229 - Buccal Versus Vaginal Misoprostol in Surgical Termination of the First Trimester Missed Abortion in Erbil Phase 2
Active, not recruiting NCT04981457 - Comparative Study Between Combined Vaginal Misoprostol Phase 1
Not yet recruiting NCT06469203 - Oxytocin Effectiveness in First Trimester Dilatation and Curettage - a Double Blind Placebo Controlled Randomized Trial N/A
Recruiting NCT02573051 - Termination Of Anembryonic Pregnancy Phase 2
Not yet recruiting NCT04215835 - Letrozole Pretreatment With Misoprostol Induction of Abortion In First-Trimester Missed Miscarriage Phase 4
Not yet recruiting NCT04217265 - Letrozole Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion Phase 4
Recruiting NCT04705324 - Dilation and Curettage Versus Operative Hysteroscopy for Missed Abortion N/A
Completed NCT02686840 - Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage Phase 3
Terminated NCT02342002 - Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial Phase 4
Recruiting NCT01775917 - The Role of Uterine Artery Doppler Parameters in the Management of Retained Products of Conception. N/A
Active, not recruiting NCT04593108 - Misoprostol With or Without Letrozole in Treatment of Missed Miscarriage