Back to resultsComparison of Dydrogesterone and Micronized Progesterone Treatments in the Treatment of Threatened Miscarriage.
Primary Purpose
Miscarriage Threatening
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Duphastone
Sponsored by
About this trial
This is an interventional treatment trial for Miscarriage Threatening
Eligibility Criteria
Inclusion Criteria:
- pregnant women with threated miscarriage in the first trimester.
Exclusion Criteria:
- - pregnant women with abortus incipiens.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Micronised progesterone
Dydrogesterone
Arm Description
Micronized progesterone will be given to 70 pregnant women with threated miscarriage.
Dydrogesterone will be given to 70 pregnant women with threated miscarriage.
Outcomes
Primary Outcome Measures
Miscarriage rate
Effects of two drugs to be used on live birth rate in pregnant women with threated miscarriage
Secondary Outcome Measures
Full Information
NCT ID
NCT05542797
First Posted
September 9, 2022
Last Updated
September 13, 2022
Sponsor
Konya Meram State Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05542797
Brief Title
Comparison of Dydrogesterone and Micronized Progesterone Treatments in the Treatment of Threatened Miscarriage.
Official Title
Comparison of Dydrogesterone and Micronized Progesterone Treatments in the Treatment of Threatened Miscarriage.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konya Meram State Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Miscarriage Threatening
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Micronised progesterone
Arm Type
Experimental
Arm Description
Micronized progesterone will be given to 70 pregnant women with threated miscarriage.
Arm Title
Dydrogesterone
Arm Type
Experimental
Arm Description
Dydrogesterone will be given to 70 pregnant women with threated miscarriage.
Intervention Type
Drug
Intervention Name(s)
Duphastone
Intervention Description
dydrogesterone hormone
Primary Outcome Measure Information:
Title
Miscarriage rate
Description
Effects of two drugs to be used on live birth rate in pregnant women with threated miscarriage
Time Frame
One year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pregnant women with threated miscarriage in the first trimester.
Exclusion Criteria:
- pregnant women with abortus incipiens.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Dydrogesterone and Micronized Progesterone Treatments in the Treatment of Threatened Miscarriage.
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