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

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

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.

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.

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