A Randomized Study on Comparing the Efficacy of Foley Catheter and Extraamniotic Saline Infusion for Labor Induction

Study Overview
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Brief Summary
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Our purpose was to compare the efficacy and safety of Foley catheter with oxytocin and extraamniotic saline infusion with oxytocin for induction of labor requiring cervical ripening.

Detailed Description
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Induction of labor is indicated when the benefit to either the mother or fetus outweighs that of continuing the pregnancy. Labor induction in the presence of an unripened cervix is associated with prolonged labor, chorioamnionitis, and cesarean delivery. Numerous mechanical and pharmacological methods have been used for cervical ripening. There are limited numbers of rigorous studies comparing the efficacy of the various methods. One of the most common mechanical methods for cervical ripening is placement of a Foley catheter with a 30 cc balloon inside the cervix, with or without the use of oxytocin. The Foley balloon will disrupt the amniotic membrane surface and cause the release of prostaglandin, a natural chemical from the cervix, to facilitate the ripening process. Oxytocin will be used concurrently as the induction agent. Recently, a modification of this method, extraamniotic saline infusion (EASI) has become more popular. The EASI method involves similar procedure including the placement of Foley catheter inside the cervix; in addition, saline solution will be infused through the catheter. This additional step is thought to further facilitate the disruption of amniotic membrane surface. Both methods are safe and become the standard treatment for cervical ripening. However, there are no published trials so far comparing the two methods. The objective of this study is to compare the efficacy and safety of Foley catheter with oxytocin and EASI with oxytocin for induction of labor requiring cervical ripening. The study is designed to be a single masked randomized trial.

Official Title
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A Randomized Clinical Trial Comparing the Efficacy and Safety of Foley Catheter Balloon With Oxytocin and Extraamniotic Saline Infusion (EASI) With Oxytocin for Induction of Labor Requiring Cervical Ripening

Conditions
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Cervical Ripening, Labor, Induced

Intervention / Treatment
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* Procedure: Foley catheter only
* Procedure: Extraamniotic saline infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: singleton gestation cephalic vertex presentation intact membrane gestational age between 30 and 42 weeks Bishop score less than or equal to 5 Exclusion Criteria: suspected chorioamnionitis placenta previa low lying placenta unexplained vaginal bleeding intrauterine fetal demise HIV any contraindication to vaginal delivery
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Foley catheter only|nan|
|Procedure: Extraamniotic saline infusion|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time interval from placement of Foley catheter to vaginal delivery |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cesarean delivery rate |  |  | 
| Incidence of maternal complications |  |  | 
| Incidence of neonatal complications |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Ripening, Labor, Induced, Balloon Dilation, Oxytocin