This is a prospective, randomized trial looking at the ideal method of labor induction for women with prelabor rupture of membranes and an unfavorable cervical Bishop score. The study will compare oral misoprostol and intravenous oxytocin.
The purpose of this study is to look at optimal induction management of prelabor rupture of membranes (PROM) at or beyond 34 weeks gestational age. Objective 1: To determine if there is a decrease in time from initiation of induction of labor to vaginal delivery in women with an unfavorable cervix with the use of oral misoprostol versus intravenous oxytocin. Hypothesis: Cervical ripening with misoprostol will be beneficial in women with an unfavorable cervix. Sub objective 1: To determine if the use of oral misoprostol for cervical ripening decreases the rate of postpartum hemorrhage in women with PROM. Hypothesis: Misoprostol use will result in significantly lower rate of postpartum hemorrhage. Sub objective 2: To evaluate the rates of infectious morbidity in peripartum women and neonates exposed to misoprostol versus oxytocin in PROM. Hypothesis: The use of oral misoprostol will result in lower rates of infectious morbidity in mother and neonate. Sub objective 3: To analyze patient satisfaction surveys. Hypothesis: Patients in the oral misoprostol group will be more satisfied with their labor experience. Exploratory Outcome To determine if there is a difference in cost between induction of labor in women with an unfavorable cervix with the use of oral misoprostol versus intravenous oxytocin. Hypothesis: The use of oral misoprostol will be cost effective in women presenting with PROM and an unfavorable cervix.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
138
Misoprostol will be dosed using the preexisting UnityPoint Health-Meriter Protocol for oral misoprostol administration.
Intravenous oxytocin administration will also follow standard, UnityPoint Health-Meriter Protocol.
UnityPoint Health- Meriter Hospital
Madison, Wisconsin, United States
Primary Endpoint: Time from initial medication administration to vaginal delivery
time from initiation of induction of labor to vaginal delivery in women with an unfavorable cervix with the use of oral misoprostol versus intravenous oxytocin
Time frame: Up to 72 hours
Secondary endpoint 1: Rate of Postpartum Hemorrhage
the rate of postpartum hemorrhage in women with prelabor rupture of membranes with use of oral misoprostol for cervical ripening
Time frame: up to 24 hours for immediate postpartum hemorrhage
Secondary endpoint 2: Rate of Suspected or Confirmed Intrapartum Intramniotic Infection
Rates of infectious morbidity in peripartum women and neonates exposed to misoprostol versus oxytocin in prelabor rupture of membranes.
Time frame: Prior to delivery
Secondary endpoint 3: Rate of Suspected Endometritis
patient satisfaction surveys
Time frame: From delivery to 6 weeks postpartum
Secondary endpoint 4: Rate of Infectious Morbidity for Neonates
Neonatal infection that is diagnosed within the first 6 weeks of life related to maternal infection diagnosed by positive blood cultures or fever.
Time frame: up to 6 weeks of life
Secondary endpoint 5: Participant Satisfaction as Measured by modified Labour Agentry Scale
The modified labour agentry scale has scores that indicate satisfaction with the patient's experience in labor
Time frame: Postpartum day one with repeat instrument at 6 weeks postpartum
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