Vaginal Progesterone for Treatment of Threatened Miscarriage (VPM)

February 23, 2016 updated by: Omar Mamdouh Shaaban

Vaginal Progesterone for Treatment of Threatened Miscarriage; Randomized Clinical Trial

The purpose of the study is to assess the efficacy of vaginal micronized progesterone in the treatment of threatened miscarriage. All eligible pregnant women will be randomized to either receive vaginal progesterone or no treatment.Evaluation will be two weeks after intervention, then every 4 weeks up to 28 weeks gestation or termination of pregnancy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

290

Phase

  • Not Applicable

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
      • Assiut, Egypt
        • Recruiting
        • Faculty of medicine
        • Principal Investigator:
          • Hany Abdel-Aleem, MD
        • Sub-Investigator:
          • Omar M Shaaban, MD

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

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Pregnant with gestational age less than 24 weeks
  2. Presented by bleeding with or without pain
  3. Single viable fetus (confirmed by Ultrasound examination)
  4. Accepting to have vaginal medication

Exclusion Criteria:

  1. Currently under medication for any chronic diseases (DM, thyroid, liver, renal, cardiac and autoimmune disease).
  2. Hypersensitivity to progesterone
  3. Any documented congenital fetal anomaly in the current pregnancy
  4. Women received hormonal treatment in the current pregnancy
  5. Patients conceived via ART

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I (Progesterone Group)

Complete bed rest as an in/or out- patient, according to patient's preference for first 48-72 hours.

  • Vaginal progesterone treatment as single daily dose of natural micronized progesterone (Prontogest ® 200 mg) at bedtime for 15 days.
  • If needed, a pain killer as Indomethacin 50 mg/ rectally twice daily up to control of uterine colic .
  • Complete abstaining from sexual activity or strenuous effort. Additionally, Rh-ve women with established viable fetuses and continue bleeding will be given a shot of anti-D immunoglobulin 300 ugm/IM ; after 12 weeks' gestation or if undergo surgical evacuation.
Drug: Vaginal Progesteron
Other Names:
  • Progesterone
Placebo Comparator: Group II ( Control group)
Will follow the same plan of management without progesterone support.
Drug: Vaginal Progesteron
Other Names:
  • Progesterone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Miscarriage rate up to 28 weeks of gestation
Time Frame: Completed 28th week
Completed 28th week

Secondary Outcome Measures

Outcome Measure
Time Frame
Gestational age at delivery or termination of pregnancy
Time Frame: Number of completed weeks at the time of delivery
Number of completed weeks at the time of delivery

Collaborators and Investigators

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

Sponsor

Omar Mamdouh Shaaban

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

February 1, 2016

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

February 19, 2016

First Submitted That Met QC Criteria

February 23, 2016

First Posted (Estimate)

February 24, 2016

Study Record Updates

Last Update Posted (Estimate)

February 24, 2016

Last Update Submitted That Met QC Criteria

February 23, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • treatment of miscarraige

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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