Comparison of Dydrogesterone and Micronized Progesterone Treatments in the Treatment of Threatened Miscarriage.
Sponsor
Konya Meram State Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05542797
Collaborator
(none)
140
2
25
Study Details
Study Description
Brief Summary
In this study, we aimed to compare the effects of two drugs used for the threated miscarriage on the miscarriage rate.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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
Study Type:
Interventional
Anticipated Enrollment
:
140 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Comparison of Dydrogesterone and Micronized Progesterone Treatments in the Treatment of Threatened Miscarriage.
Anticipated Study Start Date
:
Oct 1, 2022
Anticipated Primary Completion Date
:
Oct 1, 2023
Anticipated Study Completion Date
:
Nov 1, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Micronised progesterone Micronized progesterone will be given to 70 pregnant women with threated miscarriage. |
Drug: Duphastone
dydrogesterone hormone
|
| Experimental: Dydrogesterone Dydrogesterone will be given to 70 pregnant women with threated miscarriage. |
Drug: Duphastone
dydrogesterone hormone
|
Outcome Measures
Primary Outcome Measures
- Miscarriage rate [One year]
Effects of two drugs to be used on live birth rate in pregnant women with threated miscarriage
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 30 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- pregnant women with threated miscarriage in the first trimester.
Exclusion Criteria:
-
- pregnant women with abortus incipiens.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Konya Meram State Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hasan Ali Inal, MD,
obstetrics and gynecology,
Konya Meram State Hospital
ClinicalTrials.gov Identifier:
NCT05542797
Other Study ID Numbers:
- 351508
First Posted:
Sep 15, 2022
Last Update Posted:
Sep 15, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: