NCT05342467

Brief Summary

Comparison between gemeprost and dinoprostone to evacuate first trimester miscarriages.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

November 11, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2024

Completed
Last Updated

June 11, 2025

Status Verified

June 1, 2025

Enrollment Period

2 years

First QC Date

April 17, 2022

Last Update Submit

June 9, 2025

Conditions

Missed AbortionMedical; Abortion, FetusIncomplete Abortion

Keywords

miscarriagesfirst trimestermedical treatment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Percentage of women who experienced side effects

    from recruitment until up to one week after commencement of treatment

Study Arms (2)

Gemeprost

ACTIVE COMPARATOR

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

Drug: Gemeprost 1 Mg Vaginal PessaryDrug: Dinoprostone 3 mg

Dinoprostone

ACTIVE COMPARATOR

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

Drug: Gemeprost 1 Mg Vaginal PessaryDrug: Dinoprostone 3 mg

Interventions

Gemeprost 1 Mg Vaginal PessaryDRUG

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

DinoprostoneGemeprost
Dinoprostone 3 mgDRUG

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

DinoprostoneGemeprost

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • missed miscarriages
  • incomplete miscarriages
  • first trimester

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UKM Medical Center

Kuala Lumpur, W.Persekutuan, 56000, Malaysia

Location

UKM Medical Centre

Kuala Lumpur, W.Persekutuan, 56000, Malaysia

Location

MeSH Terms

Conditions

Abortion, MissedAbortion, IncompleteAbortion, Spontaneous

Interventions

gemeprostSuppositoriesDinoprostone

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical PreparationsProstaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Rahana Abd Rahman

    National University of Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Comparison between intravaginal gemeprost and dinoprostone.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2022

First Posted

April 22, 2022

Study Start

November 11, 2022

Primary Completion

October 28, 2024

Study Completion

October 28, 2024

Last Updated

June 11, 2025

Record last verified: 2025-06

Locations

MY(2)