A Randomized Trial of Induction Methods in Premature Rupture of Membranes

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Trial of Foley Bulb and PGE2 for Labor Induction in Premature Rupture of Membranes

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

Intervention / Treatment
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* Device: Foley balloon catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: singleton pregnancy, gestational age ≥34 weeks, rupture of membranes, cephalic presentation, bishop score ≤5, had less than three uterine contractions in every 10 minutes. Exclusion Criteria: Patients who had contraindications for vaginal delivery, previous uterine surgery, fetal malpresentation, multifetal pregnancy, more than three contractions in 10 minutes, contraindications to prostaglandins, a category II or III fetal heart rate pattern, anomalous fetus, fetal demise women with immediate delivery indications -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PGE2 with Foley balloon catheter<br>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 | Device: Foley balloon catheter<br>* 18-F Foley catheter which filling with 60 mL of saline solution will be placed into the cervix<br>|
| No Intervention: PGE2 vaginal ovule<br>10 mg PGE2 vaginal ovule will be inserted to the posterior fornix | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| induction-to- delivery time | the length of time between the beginning of induction and the end of labor | an average of one year | 

Secondary Outcome Measures

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