Vaginal Progesterone Supplementation in the Management of Preterm Labor

Not Applicable

Completed

• Conditions: Preterm Labor
• Interventions: Drug: Tocolytics; Drug: progesterone; Drug: Steroids

• Registration Number: NCT03202836
• Lead Sponsor: Chulalongkorn University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-24
• Study First Submitted QC: 2017-06-27
• Study Start: 2017-06-29
• Study First Posted: 2017-06-29
• Primary Completion: 2018-07-30
• Study Completion: 2018-07-31
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
no medication	Tocolytics	only tocolysis plus corticosteroid for 48 hours
no medication	Steroids	only tocolysis plus corticosteroid for 48 hours
vaginal progesterone	Tocolytics	Vaginal utrogestan 400 mg, vaginal suppository, once at bed time until gestational age 37 weeks and tocolysis plus corticosteroid for 48 hours
vaginal progesterone	Steroids	Vaginal utrogestan 400 mg, vaginal suppository, once at bed time until gestational age 37 weeks and tocolysis plus corticosteroid for 48 hours
vaginal progesterone	progesterone	Vaginal utrogestan 400 mg, vaginal suppository, once at bed time until gestational age 37 weeks and tocolysis plus corticosteroid for 48 hours

Primary Outcome Measures

Name	Time	Method
Time from preterm labor pain to delivery	9 weeks	time since preterm labor to delivery

Secondary Outcome Measures

Name	Time	Method
number of pregnant women deliver before 34 weeks	6 weeks	preterm birth \< 34 weeks
Number of newborn with respiratory distress syndrome	9 weeks	Number of newborn with respiratory distress syndrome
Number of newborn with necrotizing enterocolitis	9 weeks	Number of newborn with necrotizing enterocolitis
gestational age at delivery	9 weeks	gestational age at birth
number of pregnant women deliver before 37 weeks	9 weeks	preterm birth \< 37 weeks
Number of newborn with intraventricular hemorrhage	9 weeks	Number of newborn with intraventricular hemorrhage
Number of newborn with sepsis	9 weeks	Number of newborn with sepsis

Trial Locations

Locations (1)

Faculty of Medicine, Chulalongkorn University; 🇹🇭 Bangkok, Thailand