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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
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fetal Infection

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Primiparous women with a singleton pregnancy that are admitted with prelabor rupture of membranes.
  2. Women at gestational age 370/7 or more.
  3. Vertex presentation.

Exclusion Criteria:

  1. Age 18 and under.
  2. High order gestation.
  3. Women with contraindication for a vaginal delivery.
  4. Active labor.
  5. Documented fetal anomalies.
  6. Known or suspected intrauterine infection (temperature > 38 degrees, leucocytosis).
  7. Non reassuring fetal heart rate tracing.
  8. 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

    First Posted
    March 11, 2020
    Last Updated
    March 29, 2020
    Sponsor
    Rambam Health Care Campus
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    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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