A Randomized Trial of Induction Methods in Premature Rupture of Membranes

Not Applicable

• Conditions: Induction of Labor Affected Fetus / Newborn; Preterm Premature Rupture of Fetal Membranes
• Interventions: Device: Foley balloon catheter

• Registration Number: NCT03744078
• Lead Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Brief Summary

This study evaluates the addition of transcervical Foley catheter balloon and vaginal prostaglandin E2 induction in premature rupture of membranes. Half of participants will be used combine transcervical Foley catheter balloon and vaginal prostaglandin E2, while the other half will be used alone vaginal prostaglandin E2.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-27
• Study Start: 2018-04-15
• Status Verified: 2018-11
• Study First Submitted QC: 2018-11-14
• Last Update Submitted: 2018-11-14
• Study First Posted: 2018-11-16
• Last Update Posted: 2018-11-16
• Primary Completion: 2018-12-15
• Study Completion: 2019-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1. singleton pregnancy,
2. gestational age ≥34 weeks,
3. rupture of membranes,
4. cephalic presentation,
5. bishop score ≤5,
6. had less than three uterine contractions in every 10 minutes.

Exclusion Criteria

1. Patients who had contraindications for vaginal delivery,
2. previous uterine surgery,
3. fetal malpresentation,
4. multifetal pregnancy,
5. more than three contractions in 10 minutes,
6. contraindications to prostaglandins,
7. a category II or III fetal heart rate pattern,
8. anomalous fetus,
9. fetal demise
10. women with immediate delivery indications -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PGE2 with Foley balloon catheter	Foley balloon catheter	10 mg PGE2 vaginal ovul will be inserted to the posterior fornix and an 18-F Foley catheter which filling with 60 mL of saline solution will be placed into the cervix

Primary Outcome Measures

Name	Time	Method
induction-to- delivery time	an average of one year	the length of time between the beginning of induction and the end of labor

Secondary Outcome Measures

Name	Time	Method
neonatal outcome	an average of one year	APGAR scores
admission to neonatal intensive care unit	an average of one year	admission to neonatal intensive care unit
tachysystole	an average of one year	uterine contractions more than 3 in 10 minutes
postpartum hemorrhage	an average of one year	abnormal uterine bleeding after birth
chorioamnionitis	an average of one year	clinical chorioamnionitis(Maternal fever and Fetal tachycardia \>160/min and Maternal tachycardia \>100/min

Trial Locations

Locations (2)

Doga; 🇹🇷 Istanbul, Kucukcekmece, Turkey

Zeynep Kamil Education and Research Hospital; 🇹🇷 Istanbul, Uskudar, Turkey