Comparison of Dydrogesterone and Micronized Progesterone Treatments in the Treatment of Threatened Miscarriage.

September 13, 2022 updated by: Hasan Ali Inal, MD, Konya Meram State Hospital
In this study, we aimed to compare the effects of two drugs used for the threated miscarriage on the miscarriage rate.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 26 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pregnant women with threated miscarriage in the first trimester.

Exclusion Criteria:

  • - pregnant women with abortus incipiens.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Miscarriage rate
Time Frame: One year
Effects of two drugs to be used on live birth rate in pregnant women with threated miscarriage
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konya Meram State Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

September 9, 2022

First Submitted That Met QC Criteria

September 13, 2022

First Posted (Actual)

September 15, 2022

Study Record Updates

Last Update Posted (Actual)

September 15, 2022

Last Update Submitted That Met QC Criteria

September 13, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 351508

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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