Progesterone and Second Trimester Bleeding

June 5, 2018 updated by: Raed Salim, HaEmek Medical Center, Israel

The Impact of Progesterone on the Risk of Preterm Birth Among Women With Second Trimester Bleeding. A Double Blind Placebo Controlled Trial

Working hypothesis and aims:

To investigate whether progesterone treatment affects the incidence of preterm labor compared to placebo, among women with 2nd trimester bleeding.

The participants will be allocated through randomization to a study or control group. Women in the study group will receive micronized progesterone 200 mg (Utrogestan, company) with an intra-vaginal tablet once daily while the control group will receive placebo. Both women and medical staff will be blinded to group allocation. Treatment will commence on the day of inclusion to the study, but not before 16 weeks and will continue until 36 weeks gestation. Data will be collected after the conclusion of pregnancy regarding the maternal and neonatal outcome.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

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

  • Israel
      • Afula, Israel, 18101
        • Emek Medical Center
      • Hadera, Israel
        • dEP ob/gyn, Hillel Yaffe Medical Center.
      • Nazareth, Israel
        • Dep. OB/GYN, The Nazareth Hospital, E.M.M.S

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Viable pregnancy
  • Gestational age between 13 to 26 weeks
  • Vaginal bleeding from uterine origin
  • Singleton pregnancy
  • Normal clotting tests
  • Hemodynamically stable woman

Exclusion Criteria:

  • Water leak
  • Signs of preterm labor
  • Fetal malformations incompatible with life
  • Uterine malformations and other maternal conditions, i.e. liver disease, breast cancer, active thromboembolic state
  • Past preterm birth

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: placebo
placebo 200mg vaginal tablets
Active Comparator: Utrogestan
Drug: micronized progesterone 200 mg (Utrogestan)
micronized progesterone 200 mg (Utrogestan, company) as an intra-vaginal tablet once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of spontaneous preterm birth - before 37 weeks.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Maternal and fetal outcomes
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Sponsor

HaEmek Medical Center, Israel

Investigators

  • Principal Investigator: RAED SALIM, MD, HaEmek medical center affiliated to the Rappaport faculty of medicine, Technion, Haifa, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

March 1, 2011

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

January 3, 2011

First Submitted That Met QC Criteria

January 3, 2011

First Posted (Estimate)

January 4, 2011

Study Record Updates

Last Update Posted (Actual)

June 6, 2018

Last Update Submitted That Met QC Criteria

June 5, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0023-08-EMC

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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