PROMMO Trial: Oral Misoprostol vs IV Oxytocin (PROMMO)
Primary Purpose
Premature Rupture of Membrane, Induction of Labor Affected Fetus / Newborn
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Misoprostol Oral Product
Intravenous Oxytocin
Sponsored by
About this trial
This is an interventional treatment trial for Premature Rupture of Membrane
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
Sites / Locations
- UnityPoint Health- Meriter HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
oral misoprostol
intravenous oxytocin
Arm Description
At time of delivery, participants randomly assigned to either oral misoprostol will receive 50 mcg of Misoprostol every 4 hours up to 6 doses, OR until simplified Bishop score >6 (whichever is achieved first).
At time of delivery, participants randomly assigned to intravenous oxytocin, will be administered the drug per standard of labor and delivery titrations.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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.
Secondary endpoint 3: Rate of Suspected Endometritis
patient satisfaction surveys
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.
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
Full Information
NCT ID
NCT04478942
First Posted
July 15, 2020
Last Updated
December 8, 2022
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT04478942
Brief Title
PROMMO Trial: Oral Misoprostol vs IV Oxytocin
Acronym
PROMMO
Official Title
PROMMO Trial: Prelabor Rupture of Membranes Managed With Oral Misoprostol Versus Intravenous Oxytocin
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Rupture of Membrane, Induction of Labor Affected Fetus / Newborn
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
oral misoprostol
Arm Type
Active Comparator
Arm Description
At time of delivery, participants randomly assigned to either oral misoprostol will receive 50 mcg of Misoprostol every 4 hours up to 6 doses, OR until simplified Bishop score >6 (whichever is achieved first).
Arm Title
intravenous oxytocin
Arm Type
Active Comparator
Arm Description
At time of delivery, participants randomly assigned to intravenous oxytocin, will be administered the drug per standard of labor and delivery titrations.
Intervention Type
Drug
Intervention Name(s)
Misoprostol Oral Product
Other Intervention Name(s)
Oral Product
Intervention Description
Misoprostol will be dosed using the preexisting UnityPoint Health-Meriter Protocol for oral misoprostol administration.
Intervention Type
Drug
Intervention Name(s)
Intravenous Oxytocin
Other Intervention Name(s)
IV Product
Intervention Description
Intravenous oxytocin administration will also follow standard, UnityPoint Health-Meriter Protocol.
Primary Outcome Measure Information:
Title
Primary Endpoint: Time from initial medication administration to vaginal delivery
Description
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 Outcome Measure Information:
Title
Secondary endpoint 1: Rate of Postpartum Hemorrhage
Description
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
Title
Secondary endpoint 2: Rate of Suspected or Confirmed Intrapartum Intramniotic Infection
Description
Rates of infectious morbidity in peripartum women and neonates exposed to misoprostol versus oxytocin in prelabor rupture of membranes.
Time Frame
Prior to delivery
Title
Secondary endpoint 3: Rate of Suspected Endometritis
Description
patient satisfaction surveys
Time Frame
From delivery to 6 weeks postpartum
Title
Secondary endpoint 4: Rate of Infectious Morbidity for Neonates
Description
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
Title
Secondary endpoint 5: Participant Satisfaction as Measured by modified Labour Agentry Scale
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon E Blohowiak, MS
Phone
608-417-6957
Email
sblohowiak@wisc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jacquelyn Adams, MD
Phone
(608) 417-7427
Email
jadams@uwhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacquelyn Adams, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
UnityPoint Health- Meriter Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705-2216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacquelyn Adams
Phone
608-417-7427
Email
jadams@uwhealth.org
12. IPD Sharing Statement
Plan to Share IPD
No
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PROMMO Trial: Oral Misoprostol vs IV Oxytocin
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