CClinicalTrials.gg
CompletedNCT05342467Updated Jun 11, 2025

Gemeprost Versus Dinoprostone in First Trimester Miscarriages

A Phase 2 interventional study of Gemeprost 1 Mg Vaginal Pessary and Dinoprostone 3 mg in Missed Abortion, Medical; Abortion, Fetus and Incomplete Abortion, sponsored by National University of Malaysia. Completed at 2 sites in Malaysia. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-11.

Sponsored by National University of Malaysia · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
101
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study summary

Comparison between gemeprost and dinoprostone to evacuate first trimester miscarriages.

Read the 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.

02

Conditions studied

  • Missed Abortion
  • Medical; Abortion, Fetus
  • Incomplete Abortion

Keywords

  • miscarriages
  • first trimester
  • medical treatment
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • missed miscarriages
  • incomplete miscarriages
  • first trimester

Exclusion criteria

Exclusion Criteria:

  • coagulopathy
  • Rhesus negative
  • suspected ectopic pregnancy or pregnancy of unknown location
  • on anticoagulation drug
  • septic miscarriages
  • hemodynamically unstable
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
101 participants (actual)

Study arms

  • Active comparator
    Gemeprost

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

    Drug: Gemeprost 1 Mg Vaginal Pessary · Drug: Dinoprostone 3 mg

  • Active comparator
    Dinoprostone

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

    Drug: Gemeprost 1 Mg Vaginal Pessary · Drug: Dinoprostone 3 mg

Interventions

  • DrugGemeprost 1 Mg Vaginal Pessary

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

  • DrugDinoprostone 3 mg

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

05

What researchers measure

Primary outcomes

  1. Percentage of women who achieved complete evacuation

    Complete expulsion of product of conception

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

Secondary outcomes

  1. Percentage of women who experienced side effects

    side effects towards each drug such as fever, gastrointestinal upset

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

06

Study locations

2 sites
  • UKM Medical Center
    Kuala Lumpur, W.Persekutuan 56000, Malaysia
  • UKM Medical Centre
    Kuala Lumpur, W.Persekutuan 56000, Malaysia
07

References and documents

Individual participant data

Plan to share: Undecided — Yes

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05342467
Lead sponsor
National University of Malaysia
Responsible party
Sponsor
First posted
Apr 22, 2022
Start date
Nov 11, 2022
Primary completion
Oct 28, 2024
Completion
Oct 28, 2024
Last update
Jun 11, 2025

Study contacts

Rahana Abd Rahman
principal investigator · National University of Malaysia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion