Adjunctive Vaginal Progesterone in Management of Preterm Labor

Phase 4

Recruiting

• Conditions: Preterm Labor
• Interventions: Drug: Micronized progesterone

• Registration Number: NCT05997563
• Lead Sponsor: Chulalongkorn University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-08
• Study First Submitted QC: 2023-08-15
• Study Start: 2023-08-16
• Study First Posted: 2023-08-18
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30
• Primary Completion: 2025-08-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Micronized progesterone	Micronized progesterone	-

Primary Outcome Measures

Name	Time	Method
latency period	13 weeks	time from preterm labor to delivery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Vorapong Phupong; 🇹🇭 Bangkok, Thailand