Miscarriage ThreateningPhase 4NCT05542797
Comparison of Dydrogesterone and Micronized Progesterone Treatments in the Treatment of Threatened Miscarriage.
A Phase 4 study testing Duphastone in people with Miscarriage Threatening, run by Konya Meram State Hospital.
Trial summary
In this study, we aimed to compare the effects of two drugs used for the threated miscarriage on the miscarriage rate. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Miscarriage Threatening
- What is being tested?
- Duphastone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Nov 2024
- Phase
- Phase 4
- 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 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant women with threated miscarriage in the first trimester.
Who cannot join
- - pregnant women with abortus incipiens.
About this study
In this study, we aimed to compare the effects of two drugs used for the threated miscarriage on the miscarriage rate.
Read the detailed description
About 140 pregnant women who applied to our clinic due to the threated miscarriage in the first trimester will be randomly given micronized progesterone to half and dydrogesterone to the other half. After the treatment, the miscarriage rates in the groups will be compared.
- Conditions
- Miscarriage Threatening
- Being tested
- Duphastone
- Medical subject headings
- Abortion, Threatened
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuphastoneDrug
dydrogesterone hormone
| Study group | Role | What they receive |
|---|---|---|
| Micronised progesterone | Experimental | Micronized progesterone will be given to 70 pregnant women with threated miscarriage. Receives: Drug: Duphastone |
| Dydrogesterone | Experimental | Dydrogesterone will be given to 70 pregnant women with threated miscarriage. Receives: Drug: Duphastone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Miscarriage rate
Effects of two drugs to be used on live birth rate in pregnant women with threated miscarriage
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study startOct 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Miscarriage ThreateningStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Ali Inal, MD, Konya Meram State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542797
- Sponsor's protocol ID
- 351508
- Status last verified
- Sep 2022
- First submitted
- 9 Sep 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dydrogesterone and Micronized Progesterone Treatments in the Treatment of Threatened Miscarriage.
- ClinicalTrials.gov ID
- NCT05542797
- Acronym / sponsor ID
- 351508
- Conditions
- Miscarriage Threatening
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 15 Sep 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.
In this study, we aimed to compare the effects of two drugs used for the threated miscarriage on the miscarriage rate.
Detailed description
About 140 pregnant women who applied to our clinic due to the threated miscarriage in the first trimester will be randomly given micronized progesterone to half and dydrogesterone to the other half. After the treatment, the miscarriage rates in the groups will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micronised progesterone | Experimental | Drug: DuphastoneMicronized progesterone will be given to 70 pregnant women with threated miscarriage. |
| Dydrogesterone | Experimental | Drug: DuphastoneDydrogesterone will be given to 70 pregnant women with threated miscarriage. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pregnant women with threated miscarriage in the first trimester.
Key exclusion criteria (1 listed)
- - pregnant women with abortus incipiens.
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 |
|---|---|---|
| Duphastonedydrogesterone hormone | Drug | Dydrogesterone, Micronised progesterone |
Primary outcome
Miscarriage rate
Time frame: One year
Effects of two drugs to be used on live birth rate in pregnant women with threated miscarriage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Miscarriage Threatening
Not yet recruitingObservational study
Serum Progesterone and Threatened Abortion During Lactation
Threatened Abortion
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Duphastone in people with Miscarriage Threatening, run by Konya Meram State Hospital.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Miscarriage rate (time frame: One year). 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 15 Sep 2022.