Adjuvant Oxytocin for Preinduction Ripening With a Foley catheter--a Clinical Trial
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About
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.
Full description
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.
Enrollment
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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
Trial design
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Interventional model
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Data sourced from clinicaltrials.gov
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