Progesterone Supplementation in Threatened Abortion (Prothreat)

July 15, 2023 updated by: Ayman S Dawood, MD, Tanta University

Progesterone Supplementation in Threatened Abortion: Is it a Sound Practice?

To decide whether progesterone supplementation in threatened abortion is a sound practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was conducted at Obstetrics and Gynecology Department, Tanta University in the period from January 2018 to December 2018. Patients: Eligible patients (n=190) were randomly allocated into 2 groups; study group who will receive progesterone supplementation (Prog.group) and control group who will receive no treatment (place.group).

Study Type

Interventional

Enrollment (Actual)

190

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt
        • Ayman Shehata Dawood

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • threatened abortion diagnosed by history and ultrasound examination
  • singleton
  • viable fetus
  • gestational age < 20 weeks
  • closed normal length cervix.

Exclusion Criteria:

  • short cervix <2 cm Multiple pregnancy
  • dead fetus
  • open cervix ≥ 2cm
  • history of cervical surgery
  • refusal to participate.

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Progesterone
received rectal progesterone suppositories 400 mg once daily
Drug: Progesterone
received rectal progesterone suppositories 400 mg once daily
Placebo Comparator: Control group
received placebo suppositories rectally once daily.
Drug: Placebos
received placebo suppositories rectally once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
relief of pain
Time Frame: 3 weeks
questionnaire fulfilled by patient with yes or no questions
3 weeks
completion of pregnancy beyond 20 weeks
Time Frame: 12 weeks
passing the age 20 weeks
12 weeks
Stoppage of bleeding
Time Frame: 3 weeks
Cessation of bleeding
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
abortion less than 20 weeks.
Time Frame: 12 weeks
Abortion
12 weeks

Collaborators and Investigators

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

Sponsor

Tanta University

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 (Actual)

January 1, 2018

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

April 20, 2019

First Submitted That Met QC Criteria

April 25, 2019

First Posted (Actual)

April 29, 2019

Study Record Updates

Last Update Posted (Actual)

July 18, 2023

Last Update Submitted That Met QC Criteria

July 15, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prog133077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

2 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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