Cervical Ripening, Induced Labor, Pregnancy
Conditions
Keywords
induction of labor, cervical ripening, Foley catheter, oxytocin
Brief summary
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
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.
Interventions
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Delivery rate (proportion) | Within 24 hours |
Secondary
| Measure | 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 | — |
Countries
United States
Outcome results
None listed