A Randomized Trial of Induction Methods in Premature Rupture of Membranes

Zeynep Kamil Maternity and Pediatric Research and Training Hospital200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Preterm Premature Rupture of Fetal Membranes Induction of Labor Affected Fetus / Newborn

Interventions

Foley balloon catheterDEVICE

18-F Foley catheter which filling with 60 mL of saline solution will be placed into the cervix

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 -

Locations (2)

Doga

Istanbul, Kucukcekmece, Turkey (Türkiye)

RECRUITING

Zeynep Kamil Education and Research Hospital

Istanbul, Uskudar, Turkey (Türkiye)

RECRUITING