Combined Foley Catheter Balloon and PGE2 Vaginal Ovule for Induction of Labor at Term: A Randomized Study

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 in induction of labor at term. 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
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An unfavorable cervix during induction decreases the success rate of labor induction and vaginal delivery. Therefore it is required to apply cervical ripening methods for unfavorable cervices. Application of transcervical Foley catheter is an effective mechanical method and has the advantages of lower cost and lowest rate of fetal heart rate changes due to tachysystole compared with PGE1 and PGE2. Despite the advantages of mechanical methods, PGE1 and PGE2 are reported to be more effective than mechanical methods to achieve vaginal delivery within 24 hours. Although there are a lot of studies comparing PGE1, PGE2 and transcervical Foley balloon catheter separately and PGE1 combined with transcervical Foley balloon catheter, less is known about combined usage of PGE2 and transcervical Foley balloon catheter.

Official Title
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Compare Prostaglandin E2 Against to Combined Use of Transcervical Foley Catheter Balloon With Vaginal Prostaglandin E2 for Induction of Labor at Term: A Randomized Study

Conditions
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Unfavorable Cervix, Cervical Ripening

Intervention / Treatment
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* Device: Foley catheter
* Drug: PGE2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: singleton pregnancy, gestational age ≥37 weeks, intact membranes, cephalic presentation, bishop score ≤5, had obstetrical indications for induction of labor, 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 |
| --- | --- |
| Experimental: Propess 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 30 mL of saline solution will be placed into the cervix | Device: Foley catheter<br>* An 18-F Foley catheter will insert into the endocervical canal and the balloon will fill with 30 mL of saline solution.<br>Drug: PGE2<br>* 10 mg PGE2 vaginal ovul (Propess,Ferring®) will place high into the posterior vaginal fornix.<br>* Other names: propess;|
| Active Comparator: Propess vaginal ovule<br>10 mg PGE2 vaginal ovule will be inserted to the posterior fornix | Drug: PGE2<br>* 10 mg PGE2 vaginal ovul (Propess,Ferring®) will place high into the posterior vaginal fornix.<br>* Other names: propess;|

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 | the length of time between the beginning of induction and the end of labor | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| induction-to-active phase of labor time | the length of time between the beginning of induction and the onset of labor | the length of time between the beginning of induction and the onset of labor |