The purpose of this research study is to compare induction of labor using a foley catheter bulb with a low dose of oxytocin versus a foley catheter bulb with an increasing dose of oxytocin. A foley catheter bulb with or without oxytocin is a common method of labor induction in patients whose cervix is not significantly dilated or thinned out (effaced). Oxytocin (pitocin) is a medicine used to increase the number and strength of the womb's contractions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
121
Time to the Second Stage of Labor
The second stage of labor was defined as the time from complete cervical dilation to delivery of the fetus.
Time frame: foley bulb placement until second stage of labor (during admission for delivery, up to approximately 4 days)
Time to Delivery
Time from foley balloon placement until neonate delivery
Time frame: foley bulb placement until delivery (during admission for delivery, up to approximately 4 days)
Rate of Cesarean Delivery
Number of participants having a cesarean delivery
Time frame: during admission for delivery, up to approximately 4 days
Time to Active Labor
Active labor was defined as the presence of regular, painful contractions and a minimum of 2 cm cervical dilation and complete effacement in nulliparous women or a minimum of 4 cm cervical dilation in multiparous women.
Time frame: during admission for delivery, up to approximately 4 days
Time to Foley Expulsion or Removal
Time from foley balloon placement until the expulsion or removal of the foley balloon.
Time frame: foley bulb placement until removal, up to 10 hours
Incidence of Uterine Hyperstimulation
Uterine hyperstimulation (tachysystole) was defined as uterine contractions occurring greater than 12 in 20 minutes.
Time frame: during admission for delivery, up to approximately 4 days
Neonatal Outcome: Birthweight
Time frame: at time of birth (0 to 1 hour)
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Neonatal Outcome: Placental Abruption
number of participants with placental abruption
Time frame: during admission for delivery, up to approximately 4 days
Neonatal Outcome: Late Fetal Heart Rate Decelerations
Late fetal heart rate decelerations were defined as a gradual decrease in the fetal heart rate associated with uterine contraction with the nadir of the deceleration occurring after the peak of the contraction.
Time frame: during admission for delivery, up to approximately 4 days