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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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