Vaginal Progesterone Supplementation in the Management of Preterm Labor: A Randomized, Double Blind, Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- progesterone
- Conditions
- Preterm Labor
- Sponsor
- Chulalongkorn University
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Time from preterm labor pain to delivery
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Vorapong Phupong
Head of Placental Related Diseases Research Unit
Chulalongkorn University
Eligibility Criteria
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
Arms & Interventions
vaginal progesterone
Vaginal utrogestan 400 mg, vaginal suppository, once at bed time until gestational age 37 weeks and tocolysis plus corticosteroid for 48 hours
Intervention: progesterone
vaginal progesterone
Vaginal utrogestan 400 mg, vaginal suppository, once at bed time until gestational age 37 weeks and tocolysis plus corticosteroid for 48 hours
Intervention: Tocolytics
vaginal progesterone
Vaginal utrogestan 400 mg, vaginal suppository, once at bed time until gestational age 37 weeks and tocolysis plus corticosteroid for 48 hours
Intervention: Steroids
no medication
only tocolysis plus corticosteroid for 48 hours
Intervention: Tocolytics
no medication
only tocolysis plus corticosteroid for 48 hours
Intervention: Steroids
Outcomes
Primary Outcomes
Time from preterm labor pain to delivery
Time Frame: 9 weeks
time since preterm labor to delivery
Secondary Outcomes
- number of pregnant women deliver before 34 weeks(6 weeks)
- Number of newborn with respiratory distress syndrome(9 weeks)
- Number of newborn with necrotizing enterocolitis(9 weeks)
- gestational age at delivery(9 weeks)
- number of pregnant women deliver before 37 weeks(9 weeks)
- Number of newborn with intraventricular hemorrhage(9 weeks)
- Number of newborn with sepsis(9 weeks)