Clinical trial NCT04478942: PROMMO Trial: Oral Misoprostol vs IV Oxytocin
Official title: PROMMO Trial: Prelabor Rupture of Membranes Managed With Oral Misoprostol Versus Intravenous Oxytocin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Premature Rupture of Membrane
Induction of Labor Affected Fetus / Newborn
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 138
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Endpoint: Time from initial medication administration to vaginal delivery
timeFrame: Up to 72 hours
Secondary outcomes:
measure: Secondary endpoint 1: Rate of Postpartum Hemorrhage
timeFrame: up to 24 hours for immediate postpartum hemorrhage
measure: Secondary endpoint 2: Rate of Suspected or Confirmed Intrapartum Intramniotic Infection
timeFrame: Prior to delivery
measure: Secondary endpoint 3: Rate of Suspected Endometritis
timeFrame: From delivery to 6 weeks postpartum
measure: Secondary endpoint 4: Rate of Infectious Morbidity for Neonates
timeFrame: up to 6 weeks of life
measure: Secondary endpoint 5: Participant Satisfaction as Measured by modified Labour Agentry Scale
timeFrame: Postpartum day one with repeat instrument at 6 weeks postpartum
Other outcomes:
Locations:
city: Madison
country: United States
facility: UnityPoint Health- Meriter Hospital
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Jacquelyn Adams, MD
role: PRINCIPAL_INVESTIGATOR
References: