Vaginal Progesterone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With Sonographic Short Cervix

January 13, 2015 updated by: Mohamed Sayed Abdelhafez
To evaluate the value of vaginal progesterone therapy for reduction of preterm labor in asymptomatic twin pregnancies who have sonographic short cervix

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Women with twin pregnancy with transvaginal sonographic cervical length of 20-25 mm at 20-24 weeks gestational age without symptoms, signs or other risk factors of preterm labor will be included in the study. All women will be randomly divided into two groups; one group (study group) received vaginal progesterone suppositories in a dose of 400 mg daily beginning at 20-24 weeks gestational age (study group) and the other group received no treatment (control group)

Study Type

Interventional

Enrollment (Actual)

182

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
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35111
        • Obstetrics and Gynecology Department in Mansoura University Hospital
      • Mansoura, Dakahlia, Egypt
        • Private practice settings

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:

  • Women pregnant in dichorionic twins.
  • Transvaginal sonographic cervical length is 20-25 mm at 20-24 weeks gestational age.
  • No symptoms, signs or other risk factors for preterm labor.

Exclusion Criteria:

  • Age < 20 years or > 35 years.
  • Known allergy or contraindication (relative or absolute) to progesterone therapy.
  • Pregnancy by in vitro fertilization (IVF) / intracytoplasmic sperm injection (ICSI).
  • Monochorionic twins.
  • Known major fetal structural or chromosomal abnormality.
  • Intrauterine death of one fetus or death of both fetuses.
  • Fetal reduction in current pregnancy.
  • Cervical cerclage in current pregnancy.
  • Medical conditions that may lead to preterm delivery.
  • Rupture of membranes.
  • Vaginal bleeding.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Progesterone group
Women received vaginal progesterone suppositories
Drug: Progesterone
Women received vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) in a dose of 400 mg daily beginning at 20-24 weeks gestational age
Other Names:
  • Cyclogest
No Intervention: No treatment group
Women received no treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Preterm labor before 34 weeks
Time Frame: Up to 34 weeks gestational age
Up to 34 weeks gestational age

Secondary Outcome Measures

Outcome Measure
Time Frame
Neonatal respiratory distress syndrome (RDS)
Time Frame: At birth
At birth
Early neonatal death (END).
Time Frame: One month after birth
One month after birth

Collaborators and Investigators

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

Sponsor

Mohamed Sayed Abdelhafez

Investigators

  • Study Chair: Ahmed M Badawy, Prof, Mansoura University
  • Principal Investigator: Waleed El-refaie, Dr, Mansoura 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

June 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

December 24, 2014

First Submitted That Met QC Criteria

January 11, 2015

First Posted (Estimate)

January 14, 2015

Study Record Updates

Last Update Posted (Estimate)

January 15, 2015

Last Update Submitted That Met QC Criteria

January 13, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WR1

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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