Management of Prelabor Rupture of the Membranes at Term
Primary Purpose
Fetal Infection, Chorioamnionitis, Endometritis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oxytocin
Sponsored by
About this trial
This is an interventional treatment trial for Fetal Infection
Eligibility Criteria
Inclusion Criteria:
- Primiparous women with a singleton pregnancy that are admitted with prelabor rupture of membranes.
- Women at gestational age 370/7 or more.
- Vertex presentation.
Exclusion Criteria:
- Age 18 and under.
- High order gestation.
- Women with contraindication for a vaginal delivery.
- Active labor.
- Documented fetal anomalies.
- Known or suspected intrauterine infection (temperature > 38 degrees, leucocytosis).
- Non reassuring fetal heart rate tracing.
- Positive group B streptococcus status.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Immediate oxytocin infusion
Expectant management for 24 hours
Arm Description
Once the patient will arrive at the maternity ward with prelabor rupture of membranes, she will receive oxytocin for augmentation of labor.
Once the patient will arrive at the maternity ward with prelabor rupture of membranes, we will wait for spontaneous delivery to occur. After 24 hours of rupture of membranes, the woman will receive oxytocin for augmentation of labor.
Outcomes
Primary Outcome Measures
Maternal infectious morbidity
Maternal chorioamnionitis and/ or endometritis
Secondary Outcome Measures
Length of latent and active phases of labor.
According to vaginal examinations during labor
Adverse maternal outcome
infectious (chorioamnionitis/endometritis), serious maternal morbidity and mortality (death, cardiac arrest, respiratory arrest, ICU admission), post-partum hemorrhage (PPH), obstetric anal sphincter injuries (OASIS).
Adverse neonatal outcome
stillbirth, infectious disease (sepsis, meningitis, pneumonia), 5-minute Apgar score < 7, umbilical artery pH < 7.0, NICU admission, RDS, use of mechanical ventilation, NEC.
Full Information
NCT ID
NCT04307069
First Posted
March 11, 2020
Last Updated
March 29, 2020
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT04307069
Brief Title
Management of Prelabor Rupture of the Membranes at Term
Official Title
Comparison Between Two Protocols for Management of Prelabor Rupture of the Membranes at Term
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Anticipated)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prolonged rupture of membranes has been associated with increased risk of chorioamnionitis and endometritis. In this study the investigators will investigate whether an early intervention to augment labor with oxytocin is superior to expected management for spontaneous delivery (up to 24 hours).
Detailed Description
Prelabor rupture of the membranes (PROM) refers to rupture of the fetal membranes prior to the onset of regular uterine contractions.
PROM at term can be managed actively by induction of labor or expectantly by waiting for the onset of a spontaneous labor. Several studies have shown an association between expectant management and higher rates of maternal and neonatal adverse outcomes, especially infections. Furthermore, expectant management has been shown to increase the risk for cesarean deliveries (CD), chronic lung disease, cerebral palsy and neonatal mortality. It is suggested that the risk for those complications increase proportionally with the longer the duration of ruptured membranes. Others disagree with those associations.
In this study the investigators will investigate whether early administration of oxytocin is superior to expectant management of 24 hours in patients with PROM at term, in terms of time to delivery and maternal and neonatal adverse outcomes, regardless of bishop score.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Infection, Chorioamnionitis, Endometritis, Cesarean Section Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
524 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immediate oxytocin infusion
Arm Type
Experimental
Arm Description
Once the patient will arrive at the maternity ward with prelabor rupture of membranes, she will receive oxytocin for augmentation of labor.
Arm Title
Expectant management for 24 hours
Arm Type
Experimental
Arm Description
Once the patient will arrive at the maternity ward with prelabor rupture of membranes, we will wait for spontaneous delivery to occur. After 24 hours of rupture of membranes, the woman will receive oxytocin for augmentation of labor.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
pitocin
Intervention Description
The drug wil be adminisrate for augmentation of labor at admission.
Primary Outcome Measure Information:
Title
Maternal infectious morbidity
Description
Maternal chorioamnionitis and/ or endometritis
Time Frame
Up to 48 hours postpartum
Secondary Outcome Measure Information:
Title
Length of latent and active phases of labor.
Description
According to vaginal examinations during labor
Time Frame
During Labor
Title
Adverse maternal outcome
Description
infectious (chorioamnionitis/endometritis), serious maternal morbidity and mortality (death, cardiac arrest, respiratory arrest, ICU admission), post-partum hemorrhage (PPH), obstetric anal sphincter injuries (OASIS).
Time Frame
Up to 48 hours postpartum
Title
Adverse neonatal outcome
Description
stillbirth, infectious disease (sepsis, meningitis, pneumonia), 5-minute Apgar score < 7, umbilical artery pH < 7.0, NICU admission, RDS, use of mechanical ventilation, NEC.
Time Frame
Up to 48 hours postpartum
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primiparous women with a singleton pregnancy that are admitted with prelabor rupture of membranes.
Women at gestational age 370/7 or more.
Vertex presentation.
Exclusion Criteria:
Age 18 and under.
High order gestation.
Women with contraindication for a vaginal delivery.
Active labor.
Documented fetal anomalies.
Known or suspected intrauterine infection (temperature > 38 degrees, leucocytosis).
Non reassuring fetal heart rate tracing.
Positive group B streptococcus status.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gal Bachar, MD
Phone
+972524858699
Email
gal.bachar13@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gal Bachar, MD
Organizational Affiliation
Rambam Medical Health Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Management of Prelabor Rupture of the Membranes at Term
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