This randomized controlled trial of consenting women undergoing induction of labor with combined combination Foley catheter and pharmacologic cervical ripening seeks to efficacy of early amniotomy. This project will include 157 women presenting at Christiana Care Health System. Women will be included if they are at least 37 weeks gestation, have a singleton pregnancy, have intact membranes and are undergoing an induction of labor using a Foley catheter combined with either misoprostol or pitocin. Following admission, women will be randomized into either early or delayed amniotomy Women will be randomized with equal probability to the intervention group using block randomization stratified by party. Prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Artificially rupturing membranes
Foley catheter device is commonly used for cervical ripening during labor induction. It is used independently or in combination with pharmacologic augmentation. It is inserted in the cervix and the balloon is then inflated with 60 cc of saline.
Misoprostol is a medication that is commonly used for cervical ripening during labor induction. It is commonly used independently or in combination with mechanical methods, such as a foley catheter. The commonly used dose during term labor induction is 25 mcg.
Christiana Care Health Systems
Newark, Delaware, United States
time to delivery
time to delivery (hours) defined as time from Foley Catheter expulsion to delivery regardless of mode of delivery.
Time frame: Number of hours from removal of Foley catheter to delivery of neonate; up to 72 hours.
Cesarean delivery rate
binary; yes/no
Time frame: At time of delivery
Time to vaginal delivery
time to delivery (hours) defined as time from Foley Catheter expulsion to delivery
Time frame: At time of delivery
Maternal length of stay
time from admission to discharge
Time frame: through study completion, an average of 4 days
Indication for cesarean delivery
discrete
Time frame: At time of delivery
Chorioamnionitis
defined by the presence of maternal fever ≥100·4°f in the presence of maternal or fetal tachycardia or fundal tenderness
Time frame: At time of delivery
3rd/4th degree perineal laceration
binary; yes/no
Time frame: at time of delivery
Blood transfusion
binary; yes/no
Time frame: through study completion, an average of 1 year
Endometritis
binary; yes/no
Time frame: From time of delivery to time of hospital discharge; up to 6 weeks
Wound separation-infection
binary, yes/no; defined by the need for additional wound closure or the need for antibiotics
Time frame: through study completion, an average of 1 year
Neonatal death
binary, yes/no
Time frame: through study completion, an average of 1 year
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