PROMMO Trial: Oral Misoprostol vs IV Oxytocin

Induction of Labor Affected Fetus / Newborn Clinical Trial

— PROMMO  

Official title:

PROMMO Trial: Prelabor Rupture of Membranes Managed With Oral Misoprostol Versus Intravenous Oxytocin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04478942
• Other study ID #: UPH-Meriter IRB 2020-003
• Secondary ID: A532860SMPH/OBST
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 26, 2020
• Est. completion date: July 2024

Study information

• Verified date: November 2023
• Source: University of Wisconsin, Madison
• Contact: Sharon E Blohowiak, MS
• Phone: 608-417-6957
• Email: sblohowiak[@]wisc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Induction of Labor Affected Fetus / Newborn
• Premature Rupture of Membrane
• Rupture

Intervention

Drug:
• Misoprostol Oral Product
Misoprostol will be dosed using the preexisting UnityPoint Health-Meriter Protocol for oral misoprostol administration.
• Intravenous Oxytocin
Intravenous oxytocin administration will also follow standard, UnityPoint Health-Meriter Protocol.

Locations

Country	Name	City	State
United States	UnityPoint Health- Meriter Hospital	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 72 hours
Secondary	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	up to 24 hours for immediate postpartum hemorrhage
Secondary	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.	Prior to delivery
Secondary	Secondary endpoint 3: Rate of Suspected Endometritis	patient satisfaction surveys	From delivery to 6 weeks postpartum
Secondary	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.	up to 6 weeks of life
Secondary	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	Postpartum day one with repeat instrument at 6 weeks postpartum