Adjunctive Vaginal Progesterone in Management of Preterm Labor

August 28, 2023 updated by: Vorapong Phupong, Chulalongkorn University

Adjunctive Vaginal Progesterone (Micronized Progesterone Effervescent Vaginal Tablet) in Management of Preterm Labor: A Randomized Controlled Trial

This study evaluates the addition of vaginal micronized progesterone effervescent to standard treatment in the treatment of preterm labor. Half of participants will receive vaginal micronized progesterone effervescent and standard treatment, while the other half will receive only standard treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

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 Contact

Study Contact Backup

Study Locations

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • singleton pregnancy with gestational age 24-33 weeks 6 days
  • preterm labor
  • received treatment with tocolysis and corticosteroids

Exclusion Criteria:

  • conditions that need immediate delivery such as fetal distress, chorioamnionitis
  • have medical complications such as heart disease, seizure
  • fetal anomalies
  • cervical dilatation more than 5 cm
  • allergy to progesterone
  • contraindication to progesterone
  • contraindication to tocolytic use

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Active Comparator: Micronized progesterone
Drug: Micronized progesterone
Vaginal micronized progesterone effervescent once daily until delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
latency period
Time Frame: 13 weeks
time from preterm labor to delivery
13 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neonatal complications
Time Frame: 13 weeks
percentage of newborn with RDS, IVH, NEC, death
13 weeks
side effects
Time Frame: 13 weeks
percentage of side effects such as headache, nausea/vomiting
13 weeks
compliance
Time Frame: 13 weeks
percentage of complete drug use
13 weeks
gestational age at delivery
Time Frame: 13 weeks
mean gestational age at delivery
13 weeks
preterm delivery less than 34 weeks
Time Frame: 10 weeks
percentage of preterm delivery less than 34 weeks
10 weeks
preterm delivery less than 37 weeks
Time Frame: 13 weeks
percentage of preterm delivery less than 37 weeks
13 weeks
good satisfaction
Time Frame: 13 weeks
percentage of good satisfaction
13 weeks
good quality of life
Time Frame: 13 weeks
percentage of good quality of life
13 weeks
Time to the recurrence of uterine contractions
Time Frame: 13 weeks
mean time to the recurrence of uterine contractions
13 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 (Actual)

August 16, 2023

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

August 8, 2023

First Submitted That Met QC Criteria

August 15, 2023

First Posted (Actual)

August 18, 2023

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 681/2023

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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