Comparing Foley Catheter Balloon With Early Amniotomy for Induction of Labor at Term

Study Overview
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Brief Summary
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This study evaluates the intervention for induction of labor with low bishop scores . One group will be induced by transcervical Foley catheter balloon and vaginal PGE2 and other group will be induced by early amniotomy and PGE2 vaginal ovule for induction of labor at term.

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. Early amniotomy is another effective method to ripen cervix. we aim to evaluate which method is superior to another.

Official Title
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Comparing Combined Foley Catheter Balloon and PGE2 Vaginal Ovule With Early Amniotomy and PGE2 for Induction of Labor at Term: A Randomized Study

Conditions
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Induced Vaginal Delivery

Intervention / Treatment
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* Procedure: early amniotomy
* Device: foley catheter balloon placement


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,

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: early amniotomy plus dinoprostone<br>10 mg dinoprostone vaginal ovul will be inserted to the posterior fornix. Early amniotomy will be done in the early active phase of labor for early amniotomy group ( half of participants) when the cervix will be dilated 3 cm using the amniotomy hook. | Procedure: early amniotomy<br>* 10 mg PGE2 vaginal ovul will be inserted to the posterior fornix. Early amniotomy will be done in the early active phase of labor for early amniotomy group ( half of participants) when the cervix will be dilated 3 cm using the amniotomy hook.<br>|
| Experimental: foley balloon catheter plus dinoprostone<br>an 18-F Foley catheter which filling with 30 mL of saline solution will be placed into the cervix and after placement of balloon catheter 10 mg dinoprostone vaginal ovul will be inserted to the posterior fornix | Device: foley catheter balloon placement<br>* an 18-F Foley catheter which filling with 30 mL of saline solution will be placed into the cervix and after placement of balloon catheter 10 mg PGE2 vaginal ovul will be inserted to the posterior fornix<br>* Other names: mechanic and medical method;|

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 | from the beginning of induction until the 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 | from the beginning of induction until the labor | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dinoprostone, early amniotomy, labor induction, foley bulb