Amniotomy is commonly done in the management of labor, though there is little research guiding the timing of amniotomy. Recent research largely suggests a benefit to earlier amniotomy, reporting shorter labor courses with no increase in the number of cesarean deliveries. This is some research, however, that reports an increase in cesarean deliveries with early amniotomy. Due to the small number of studies evaluating this topic, as well as the conflicting results, more research is needed. Additionally, the method of cervical ripening prior to amniotomy should be accounted for, as it may have an impact on the overall labor course. The purpose of this study is to evaluate the impact of early versus delayed amniotomy on time of delivery time from induction to the active phase of labor, as well on total time to delivery and maternal and neonatal outcomes in women undergoing cervical ripening with the Foley balloon.
This will be an unblinded randomized clinical trial. The investigators will recruit 174 pregnant women undergoing induction of labor. Recruitment will occur on the Labor and Delivery unit at the time of induction, after the decision has been made to place a Foley balloon for cervical ripening. Enrolled subjects will be randomized to early or delayed amniotomy. Subjects randomized to early amniotomy will undergo amniotomy within 2 hours of Foley balloon removal. Subjects randomized to delayed amniotomy will undergo amniotomy at least 4 hours after Foley balloon removal.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Artificial rupture of amniotic membranes
The Foley balloon is inserted transcervically and inflated to a volume of 60 cc. It may be spontaneously expelled or manually removed if in place for 12 hours.
University of Texas Medical Branch
Galveston, Texas, United States
Time to Active Phase of Labor
Total time from initiation of labor induction to reaching 6 cm cervical dilation
Time frame: At delivery
Time to Delivery
Total time from initiation of labor induction to delivery
Time frame: At delivery
Vaginal Delivery Rate
Rate of vaginal delivery within 24, 36, and 48 hours
Time frame: At delivery
Cesarean Section Rate
Rate of cesarean section and indications
Time frame: At delivery
Maternal Infection Composite
Includes isolated maternal fever, chorioamnionitis, endometritis, wound infection
Time frame: From admission to discharge, up to 2 weeks
Umbilical Cord Prolapse
Rates of umbilical cord prolapse
Time frame: At delivery
Neonatal Outcome Composite
Neonatal outcome composite including NICU admission, respiratory support, hypoxic ischemic encephalopathy, seizures, sepsis, meconium aspiration syndrome, birth trauma, intracranial or subgaleal hemorrhage, hypotension requiring pressors, and perinatal death.
Time frame: From admission to discharge, up to 2 weeks
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