Induction of Labor Affected Fetus / Newborn, Premature Rupture of Membrane
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGMisoprostol Oral Product
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.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Early Term to late term pregnancy (\>37 weeks and 0 days and \<42 weeks and 0 days) * Late Preterm Pregnancy (34 weeks and 0 days and \<37 weeks) * Confirmed rupture of membranes by either sterile speculum exam or AmniSure * Simplified Bishop Score ≤ 6 * Maternal Age \> 18 years old * Singleton gestation * Appropriate gestational age dating by certain LMP or ultrasound performed prior to 20 weeks gestational age
Exclusion criteria
* Concern for intra-amniotic infection * Previous Cesarean delivery * Lack of appropriate dating criteria for the pregnancy * Inability to give informed consent in the patient's native language * Known bleeding disorder such as von Willebrand's disease or hemophilia * Anticoagulation administration within 24 hours of delivery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint: Time from initial medication administration to vaginal delivery | Up to 72 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary endpoint 1: Rate of Postpartum Hemorrhage | up to 24 hours for immediate postpartum hemorrhage | the rate of postpartum hemorrhage in women with prelabor rupture of membranes with use of oral misoprostol for cervical ripening |
| Secondary endpoint 2: Rate of Suspected or Confirmed Intrapartum Intramniotic Infection | Prior to delivery | Rates of infectious morbidity in peripartum women and neonates exposed to misoprostol versus oxytocin in prelabor rupture of membranes. |
| Secondary endpoint 3: Rate of Suspected Endometritis | From delivery to 6 weeks postpartum | patient satisfaction surveys |
| Secondary endpoint 4: Rate of Infectious Morbidity for Neonates | up to 6 weeks of life | Neonatal infection that is diagnosed within the first 6 weeks of life related to maternal infection diagnosed by positive blood cultures or fever. |
| Secondary endpoint 5: Participant Satisfaction as Measured by modified Labour Agentry Scale | Postpartum day one with repeat instrument at 6 weeks postpartum | The modified labour agentry scale has scores that indicate satisfaction with the patient's experience in labor |
Countries
United States
Outcome results
None listed