Adjunctive Vaginal Progesterone in Management of Preterm Labor

Chulalongkorn University (Other)
Overall Status
Not yet recruiting ID

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Micronized progesterone
Phase 4

Study Design

Study Type:
Anticipated Enrollment :
48 participants
Intervention Model:
Parallel Assignment
None (Open Label)
Primary Purpose:
Official Title:
Adjunctive Vaginal Progesterone (Micronized Progesterone Effervescent Vaginal Tablet) in Management of Preterm Labor: A Randomized Controlled Trial
Anticipated Study Start Date :
Aug 16, 2023
Anticipated Primary Completion Date :
Aug 31, 2025
Anticipated Study Completion Date :
Oct 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Micronized progesterone

Drug: Micronized progesterone
Vaginal micronized progesterone effervescent once daily until delivery

No Intervention: Control

Outcome Measures

Primary Outcome Measures

  1. latency period [13 weeks]

    time from preterm labor to delivery

Secondary Outcome Measures

  1. gestational age at delivery [13 weeks]

    mean gestational age at delivery

  2. preterm delivery less than 34 weeks [10 weeks]

    percentage of preterm delivery less than 34 weeks

  3. preterm delivery less than 37 weeks [13 weeks]

    percentage of preterm delivery less than 37 weeks

  4. neonatal complications [13 weeks]

    percentage of newborn with RDS, IVH, NEC, death

  5. side effects [13 weeks]

    percentage of side effects such as headache, nausea/vomiting

  6. compliance [13 weeks]

    percentage of complete drug use

  7. good satisfaction [13 weeks]

    percentage of good satisfaction

  8. good quality of life [13 weeks]

    percentage of good quality of life

  9. Time to the recurrence of uterine contractions [13 weeks]

    mean time to the recurrence of uterine contractions

Eligibility Criteria


Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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

Contacts and Locations


No locations specified.

Sponsors and Collaborators

  • Chulalongkorn University


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

Study Documents (Full-Text)

None provided.

More Information


Responsible Party:
Vorapong Phupong, Professor Vorapong Phupong, Chulalongkorn University Identifier:
Other Study ID Numbers:
  • 681/2023
First Posted:
Aug 18, 2023
Last Update Posted:
Aug 18, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2023