Missed AbortionPhase 2NCT05342467
Gemeprost Versus Dinoprostone in First Trimester Miscarriages
A Phase 2 study testing Gemeprost 1 Mg Vaginal Pessary and Dinoprostone 3 mg in people with Missed Abortion and Medical; Abortion, Fetus, run by National University of Malaysia at 2 sites in Malaysia.
Trial summary
Comparison between gemeprost and dinoprostone to evacuate first trimester miscarriages. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Missed Abortion, Medical; Abortion, Fetus, Incomplete Abortion
- What is being tested?
- Gemeprost 1 Mg Vaginal Pessary and Dinoprostone 3 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 2 sitesMalaysia
- Study dates
- 11 Nov 2022to 28 Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- missed miscarriages
- incomplete miscarriages
- first trimester
Who cannot join
- coagulopathy
- Rhesus negative
- suspected ectopic pregnancy or pregnancy of unknown location
- on anticoagulation drug
- septic miscarriages
- hemodynamically unstable
Trial locations and contacts
2 sites in 1 country.
Malaysia2 sites
UKM Medical Center
Kuala Lumpur, W.Persekutuan, 56000
UKM Medical Centre
Kuala Lumpur, W.Persekutuan, 56000
About this study
Official title: Gemeprost Versus Dinoprostone in the Medical Management of First Trimester Miscarriages: a Randomized Controlled Study
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.
- Being tested
- Gemeprost 1 Mg Vaginal Pessary, Dinoprostone 3 mg
- Keywords
- miscarriages, first trimester, medical treatment
- Medical subject headings
- Abortion, Missed, Abortion, Incomplete, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemeprost 1 Mg Vaginal PessaryDrug
Intravaginal gemeprost 1 mg inserted 3 hourly for maximum of 5 doses in 24 hours
Dinoprostone 3 mgDrug
Intravaginal dinoprostone 3 mg inserted 4 hourly for maximum of 3 doses in 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Gemeprost | Active comparator | Gemeprost 1 mg inserted 3 hourly for maximum of 5 doses in 24 hours. Receives: Drug: Gemeprost 1 Mg Vaginal Pessary; Drug: Dinoprostone 3 mg |
| Dinoprostone | Active comparator | Dinoprostone 3 mg inserted 4 hourly for maximum of 3 doses in 24 hours. Receives: Drug: Gemeprost 1 Mg Vaginal Pessary; Drug: Dinoprostone 3 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of women who achieved complete evacuation
Complete expulsion of product of conception
Measured: 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
Measured: from recruitment until up to one week after commencement of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start11 Nov 2022
- Primary completion28 Oct 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missed AbortionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison between intravaginal gemeprost and dinoprostone.
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rahana Abd Rahman, Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342467
- Sponsor's protocol ID
- FF-2021-504
- Status last verified
- Jun 2025
- First submitted
- 17 Apr 2022
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gemeprost Versus Dinoprostone in the Medical Management of First Trimester Miscarriages: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05342467
- Acronym / sponsor ID
- FF-2021-504
- Keywords
- miscarriages, first trimester, medical treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison between gemeprost and dinoprostone to evacuate first trimester miscarriages.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison between intravaginal gemeprost and dinoprostone.
| Arm | Type | Receives |
|---|---|---|
| Gemeprost | Active comparator | Drug: Gemeprost 1 Mg Vaginal Pessary, Drug: Dinoprostone 3 mgGemeprost 1 mg inserted 3 hourly for maximum of 5 doses in 24 hours. |
| Dinoprostone | Active comparator | Drug: Gemeprost 1 Mg Vaginal Pessary, Drug: Dinoprostone 3 mgDinoprostone 3 mg inserted 4 hourly for maximum of 3 doses in 24 hours. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- missed miscarriages
- incomplete miscarriages
- first trimester
Key exclusion criteria (6 listed)
- coagulopathy
- Rhesus negative
- suspected ectopic pregnancy or pregnancy of unknown location
- on anticoagulation drug
- septic miscarriages
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemeprost 1 Mg Vaginal PessaryIntravaginal gemeprost 1 mg inserted 3 hourly for maximum of 5 doses in 24 hours | Drug | Dinoprostone, Gemeprost |
| Dinoprostone 3 mgIntravaginal dinoprostone 3 mg inserted 4 hourly for maximum of 3 doses in 24 hours | Drug | Dinoprostone, Gemeprost |
Primary outcome
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
1 secondary outcome
Percentage of women who experienced side effects
Time frame: from recruitment until up to one week after commencement of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: Undecided. Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rahana Abd Rahman principal investigator
National University of Malaysia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemeprost 1 Mg Vaginal Pessary and Dinoprostone 3 mg in people with Missed Abortion and Medical; Abortion, Fetus, run by National University of Malaysia at 2 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of women who achieved complete evacuation (time frame: from recruitment until up to one week after commencement of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.