Adjuvant Oxytocin for Preinduction Ripening With a Foley catheter--a Clinical Trial

Study Overview
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Brief Summary
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The transcervical Foley catheter (TFC) is a proven and effective mode of cervical ripening. It is common practice to use TFC with simultaneous low-dose oxytocin under the assumption that the combination results in a more successful labor induction. Scientific validation of this practice is lacking. We seek to determine if the addition of oxytocin to TFC improves induction success.

Detailed Description
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This is a prospective, randomized trial that aims to enroll 200 singleton pregnancies presenting for preinduction ripening. Patients will be randomized to receive either TFC alone (control) or TFC plus low-dose oxytocin (treatment). Providers will not blinded to use of oxytocin and labor was managed according to routine obstetric protocols. This study is powered to detect a 20% difference in the proportion of patients delivered within 24 hours, the primary outcome. Secondary outcomes are related to vaginal delivery rate, duration of induction, complications, and pain management.

Official Title
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A Prospective, Randomized Trial of Transcervical Foley Catheter With or Without Oxytocin for Preinduction Cervical Ripening

Conditions
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Pregnancy, Induced Labor, Cervical Ripening

Intervention / Treatment
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* Drug: low dose oxytocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: singleton gestation presenting for induction as determined by their primary obstetrical provider with fetuses in cephalic presentation gestational age greater than 23 weeks Exclusion Criteria: any condition precluding vaginal delivery estimated fetal weight >4500 grams a previous attempt at ripening or induction during the pregnancy clinically significant cervical or vaginal infection chorioamnionitis HIV hepatitis B or C unexplained vaginal bleeding low-lying placenta abnormal cervical anatomy or cervical cerclage latex allergy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: low dose oxytocin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivery rate (proportion) |  | Within 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vaginal delivery rate |  | within 24 hours | 
| use of anesthesia/analgesia |  | during induction and labor | 
| overall complication rate (composite) |  |  | 
| duration of induction and labor |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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induction of labor, cervical ripening, Foley catheter, oxytocin