Pr-conceptional Progesterone for Unexplained Recurrent Miscarriage

April 3, 2016 updated by: alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt
In women with unexplained recurrent miscarriages, progesterone (400 mg pessaries, twice daily), started soon as possible at luteal phase and after a positive pregnancy test and continued to 28 weeks of gestation, compared to placebo, ).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Progesterone improves secondary outcomes such as gestation at delivery, on-going pregnancy at 12 weeks, survival at 28 days of neonatal life.

. Progesterone, compared to placebo, does not incur substantial adverse effects to the mother or the neonate.

Explore differential or subgroup effects of progesterone in prognostic subgroups.

. Perform an economic evaluation for cost-effectiveness.

Study Type

Interventional

Enrollment (Actual)

700

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
      • Assiut, Egypt
        • Women's Health Hospital

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 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Women with unexplained recurrent miscarriages (2 or more consecutive first trimester miscarriages).
  2. Age 18-39 years at randomisation (likelihood of miscarriages due to chromosomal aberrations is higher in older women; such miscarriages are unlikely to be prevented by progesterone therapy).
  3. Spontaneous conception (as confirmed by urinary pregnancy tests).
  4. Willing and able to give informed consent.

Exclusion Criteria:

  1. Age less than twenty or above forty years old.
  2. Antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies [IgG or IgM]); other recognised thrombophilic conditions (testing according to usual clinic practice)
  3. Intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy).
  4. Fibroids distorting uterine cavity.
  5. Abnormal parental karyotype.
  6. Other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (SLE).

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
Active Comparator: Progesterone group
progesterone (400 mg pessary, once daily)
Drug: Progesterone
Placebo Comparator: Placebo group
Placebo (pessary, once daily)
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients continued the pregnancy beyond 20 weeks gestation.
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of miscarriages
Time Frame: 2 years
2 years

Other Outcome Measures

Outcome Measure
Time Frame
Number of Live Birth
Time Frame: 2 years
2 years
Number of preterm delivery
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

Woman's Health University Hospital, Egypt

Investigators

  • Principal Investigator: Alaa M Ismail, M D, Faculity of medicine,Assiut 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

September 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

August 17, 2012

First Submitted That Met QC Criteria

August 21, 2012

First Posted (Estimate)

August 22, 2012

Study Record Updates

Last Update Posted (Estimate)

April 5, 2016

Last Update Submitted That Met QC Criteria

April 3, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPROURM

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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