Vaginal Progesterone Supplementation in the Management of Preterm Labor

January 29, 2019 updated by: Vorapong Phupong, Chulalongkorn University

Vaginal Progesterone Supplementation in the Management of Preterm Labor: A Randomized, Double Blind, Controlled Trial

This study evaluates the addition of vaginal progesterone in the management of preterm labor. Half of participants will receive vaginal progesterone, tocolysis and corticosteroid, while the other half will receive only tocolysis and corticosteroid.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

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

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • singleton pregnant women with preterm labor, gestational age 24-34 weeks

Exclusion Criteria:

  • have indicated preterm birth
  • allergy to progesterone
  • fetal anomalies
  • cervical dilate > 5 cm.
  • have medical disease
  • have obstetric complication

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: vaginal progesterone
Vaginal utrogestan 400 mg, vaginal suppository, once at bed time until gestational age 37 weeks and tocolysis plus corticosteroid for 48 hours
Drug: progesterone
vaginal utrogestan
Other Names:
  • utrogestan
Drug: Tocolytics
tocolysis for 48 hours
Drug: Steroids
antenatal corticosteroids for 48 hours
OTHER: no medication
only tocolysis plus corticosteroid for 48 hours
Drug: Tocolytics
tocolysis for 48 hours
Drug: Steroids
antenatal corticosteroids for 48 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from preterm labor pain to delivery
Time Frame: 9 weeks
time since preterm labor to delivery
9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gestational age at delivery
Time Frame: 9 weeks
gestational age at birth
9 weeks
number of pregnant women deliver before 34 weeks
Time Frame: 6 weeks
preterm birth < 34 weeks
6 weeks
number of pregnant women deliver before 37 weeks
Time Frame: 9 weeks
preterm birth < 37 weeks
9 weeks
Number of newborn with respiratory distress syndrome
Time Frame: 9 weeks
Number of newborn with respiratory distress syndrome
9 weeks
Number of newborn with intraventricular hemorrhage
Time Frame: 9 weeks
Number of newborn with intraventricular hemorrhage
9 weeks
Number of newborn with necrotizing enterocolitis
Time Frame: 9 weeks
Number of newborn with necrotizing enterocolitis
9 weeks
Number of newborn with sepsis
Time Frame: 9 weeks
Number of newborn with sepsis
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, MD, 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 (ACTUAL)

June 29, 2017

Primary Completion (ACTUAL)

July 30, 2018

Study Completion (ACTUAL)

July 31, 2018

Study Registration Dates

First Submitted

June 24, 2017

First Submitted That Met QC Criteria

June 27, 2017

First Posted (ACTUAL)

June 29, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 230/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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