Oral Progestogen Supplementation in the Prevention of Recurrent Uterine Contraction in Preterm Labor

January 26, 2016 updated by: Vorapong Phupong, Chulalongkorn University

A Randomized, Double Blinded, Placebo Controlled Trial of Oral Progestogen Supplementation in the Prevention of Recurrent Uterine Contraction in Preterm Labor

The purpose of this study is to evaluate the effect of oral progesterone supplementation in preterm labor on the prevention of recurrent uterine contraction and prolonging pregnancy period, and its side effect.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

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

  • Thailand
      • Bangkok, Thailand, 10330
        • Faculty of Medicine, Chulalongkorn University

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

15 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Singleton pregnancy
  • Preterm labor
  • GA24-34wk
  • Intact membranes

Exclusion Criteria:

  • Maternal/fetal condition requiring immediate delivery ex. Chorioamnionitis, fetal distress
  • Placenta previa
  • medical and obstetric complications
  • allergy to dydrogesterone

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
Active Comparator: Dydrogesterone
tocolytic + corticosteroids + Dydrogesterone 10 mg/tablet prepare in capsule, 1 cap oral every 12 hours, starting form enrollment until gestational age 37 weeks
Drug: dydrogesterone
Other Names:
  • Duphaston
Placebo Comparator: Placebo
tocolytic + corticosteroids + Placebo prepare in capsule, 1 cap oral every 12 hours, starting form enrollment until gestational age 37 weeks
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The recurrence of uterine contraction within 48 hours after stop tocolytic
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Time from preterm labor pain to delivery
Time Frame: 9 weeks
9 weeks
Gestational age at delivery
Time Frame: 9 weeks
9 weeks
Number of newborn with respiratory distress syndrome
Time Frame: 9 weeks
9 weeks
side effects
Time Frame: 9 weeks
9 weeks
Number of newborn with intraventricular hemorrhage
Time Frame: 9 weeks
9 weeks
Number of newborn with necrotizing enterocolitis
Time Frame: 9 weeks
9 weeks
Number of newborn with sepsis
Time Frame: 9 weeks
9 weeks

Collaborators and Investigators

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

Sponsor

Chulalongkorn University

Investigators

  • Study Director: Vorapong Phupong, M.D., Chulalongkorn University

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

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

August 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

October 3, 2014

First Submitted That Met QC Criteria

October 8, 2014

First Posted (Estimate)

October 13, 2014

Study Record Updates

Last Update Posted (Estimate)

January 28, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA57/104

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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