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Adjunctive Vaginal Progesterone in Management of Preterm Labor

Sponsor
Chulalongkorn University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05997563
Collaborator
(none)
48
Enrollment
2
Arms
26.5
Anticipated Duration (Months)

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:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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

Criteria

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

Locations

No locations specified.

Sponsors and Collaborators

  • Chulalongkorn University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Vorapong Phupong, Professor Vorapong Phupong, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT05997563
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:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Progesterone

Study Results

No Results Posted as of Aug 18, 2023