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OpenTrials
Completed

NCT Number: NCT05342467

Gemeprost Versus Dinoprostone in First Trimester Miscarriages

Comparison between gemeprost and dinoprostone to evacuate first trimester miscarriages.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

UKM Medical Center, Kuala Lumpur, W.Persekutuan, Malaysia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Percentage of women who achieved complete evacuation

    Time frame: from recruitment until up to one week after commencement of treatment

    Complete expulsion of product of conception

Secondary outcomes

  1. Percentage of women who experienced side effects

    Time frame: from recruitment until up to one week after commencement of treatment

    side effects towards each drug such as fever, gastrointestinal upset

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 22, 2022
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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