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Randomized Control Trial of Intracervical Balloon Placement vs Oxytocin in Women With Term PROM and Unripe Cervices

Primary Purpose

Premature Rupture of Membrane, Unfavorable Cervix

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intracervical balloon catheter
Oxytocin
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Rupture of Membrane focused on measuring cervical ripening, term premature rupture of membrane, intracervical balloon catheter

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Nulliparous women, Women aged 18-50 years, Singleton gestation, Vertex presentation, Live fetus, Rupture of membranes confirmed by sterile speculum examination > 37 weeks of gestation at time of rupture of membranes, Bishop score < 6

Exclusion Criteria:

Multiparous women, Bishop score >6, Multifetal gestation, Contraindication to labor including placenta previa , Maternal fever prior to randomization: T >100.4 F , Known fetal anomalies

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intracervical Balloon Catheter Group

    Immediate low-dose oxytocin infusion group

    Arm Description

    The intracervical balloon catheter will be passed through the cervix either with a speculum exam or by a digital exam. Then the catheter balloon will be filled with 80 cc of sterile fluid. The catheter will be pulled to tension and taped to the patient's leg. Patients will have the option to IV pain medication at the time of intracervical balloon placement. The intracervical balloon will remain in place for 6 hours unless it falls out spontaneously. At the 6 hour mark, a vaginal exam will assess if the intracervical balloon has pulled through the cervix or if it needs further tension. The intracervical balloon will remain in place a maximum of 12 hours. After a maximum of 12 hours in place the intracervical balloon will be removed and oxytocin will be started per protocol.

    At our institution the policy for oxytocin infusion is to start at a low dose of 2mu/min and to increase by 2mu/min at 15 to 20 minute intervals based on how often uterine contractions are occuring. A specific order from a physician is required to increase the oxytocin dose above 20 mu/min. Oxytocin will be titrated per usual protocol.

    Outcomes

    Primary Outcome Measures

    Time from start of induction defined as time of IBC (intracervical balloon catheter) placement or initiation of oxytocin until delivery in hours
    length of induction

    Secondary Outcome Measures

    Length of first stage of labor
    length of first stage of labor
    Cesarean delivery rate
    number of cesarean deliveries
    chorioamnionitis
    Maternal temperature >100.4 F during labor with associated maternal or fetal tachycardia
    Endometritis
    temperature >100.4 F in the postpartum period with initiation of antibiotics in postpartum period
    Postpartum hemorrhage
    Estimated blood loss (EBL) >500 cc from a vaginal delivery and EBL >1000 cc from a cesarean delivery
    Epidural use
    epidural anesthesia use during labor
    Neonatal 5-minute Apgar score
    apgar score at 5 minutes of life after delivery of neonate
    Neonatal umbilical arterial and venous acid base status
    assessment of acid-base status of neonate at the time of delivery

    Full Information

    First Posted
    April 19, 2017
    Last Updated
    June 12, 2017
    Sponsor
    Northwestern University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03172858
    Brief Title
    Randomized Control Trial of Intracervical Balloon Placement vs Oxytocin in Women With Term PROM and Unripe Cervices
    Official Title
    A Randomized Trial of Intracervical Balloon Placement Versus Intravenous Oxytocin in Women With Premature Rupture of Membranes and Unripe Cervices
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2017 (Anticipated)
    Primary Completion Date
    January 2019 (Anticipated)
    Study Completion Date
    January 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Northwestern University

    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
    This study is designed to determine if an intracervical balloon catheter (IBC) is better than oxytocin for induction of labor in the setting of premature rupture of membranes (PROM) or breaking the bag of water prior to onset of labor. The investigators suspect that an intracervical balloon catheter will shorten the time interval from initiation of induction of labor to delivery.
    Detailed Description
    There are not enough studies to support the use of intracervical balloon catheter (IBC) use in term premature rupture of membranes (PROM). Prospective randomized studies comparing IBC placement to oxytocin use in induction of labor for term PROM do not exist. Intracervical Balloon Catheter has been shown to reduce duration of labor for women with intact membranes undergoing induction of labor. The practice at this institution is to use oxytocin to start contractions when a woman has PROM. This study will examine IBC compared to oxytocin use in term PROM. This will allow for the evaluation of a cervical ripening method for term PROM that may improve women's outcomes. Other outcomes for this study are rates of infection during labor, cesarean section, and adverse maternal and/or neonatal outcomes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premature Rupture of Membrane, Unfavorable Cervix
    Keywords
    cervical ripening, term premature rupture of membrane, intracervical balloon catheter

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomized controlled trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intracervical Balloon Catheter Group
    Arm Type
    Experimental
    Arm Description
    The intracervical balloon catheter will be passed through the cervix either with a speculum exam or by a digital exam. Then the catheter balloon will be filled with 80 cc of sterile fluid. The catheter will be pulled to tension and taped to the patient's leg. Patients will have the option to IV pain medication at the time of intracervical balloon placement. The intracervical balloon will remain in place for 6 hours unless it falls out spontaneously. At the 6 hour mark, a vaginal exam will assess if the intracervical balloon has pulled through the cervix or if it needs further tension. The intracervical balloon will remain in place a maximum of 12 hours. After a maximum of 12 hours in place the intracervical balloon will be removed and oxytocin will be started per protocol.
    Arm Title
    Immediate low-dose oxytocin infusion group
    Arm Type
    Active Comparator
    Arm Description
    At our institution the policy for oxytocin infusion is to start at a low dose of 2mu/min and to increase by 2mu/min at 15 to 20 minute intervals based on how often uterine contractions are occuring. A specific order from a physician is required to increase the oxytocin dose above 20 mu/min. Oxytocin will be titrated per usual protocol.
    Intervention Type
    Device
    Intervention Name(s)
    Intracervical balloon catheter
    Intervention Description
    cervical ripening balloon
    Intervention Type
    Drug
    Intervention Name(s)
    Oxytocin
    Intervention Description
    medication used to induce contractions
    Primary Outcome Measure Information:
    Title
    Time from start of induction defined as time of IBC (intracervical balloon catheter) placement or initiation of oxytocin until delivery in hours
    Description
    length of induction
    Time Frame
    24-48 hours/duration of induction of labor
    Secondary Outcome Measure Information:
    Title
    Length of first stage of labor
    Description
    length of first stage of labor
    Time Frame
    delivery (from initial cervical dilation to 10 cm cervical dilation])
    Title
    Cesarean delivery rate
    Description
    number of cesarean deliveries
    Time Frame
    24-48 hours/duration of induction of labor
    Title
    chorioamnionitis
    Description
    Maternal temperature >100.4 F during labor with associated maternal or fetal tachycardia
    Time Frame
    24-48 hours/duration of induction of labor
    Title
    Endometritis
    Description
    temperature >100.4 F in the postpartum period with initiation of antibiotics in postpartum period
    Time Frame
    from time of delivery until 2 days after delivery for vaginal deliveries and 3 days after delivery for cesarean sections
    Title
    Postpartum hemorrhage
    Description
    Estimated blood loss (EBL) >500 cc from a vaginal delivery and EBL >1000 cc from a cesarean delivery
    Time Frame
    at time of delivery and up to 24 hours after delivery
    Title
    Epidural use
    Description
    epidural anesthesia use during labor
    Time Frame
    24-48 hours/duration of induction of labor
    Title
    Neonatal 5-minute Apgar score
    Description
    apgar score at 5 minutes of life after delivery of neonate
    Time Frame
    5 minutes after delivery
    Title
    Neonatal umbilical arterial and venous acid base status
    Description
    assessment of acid-base status of neonate at the time of delivery
    Time Frame
    at the time of delivery

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    pregnancy
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Nulliparous women, Women aged 18-50 years, Singleton gestation, Vertex presentation, Live fetus, Rupture of membranes confirmed by sterile speculum examination > 37 weeks of gestation at time of rupture of membranes, Bishop score < 6 Exclusion Criteria: Multiparous women, Bishop score >6, Multifetal gestation, Contraindication to labor including placenta previa , Maternal fever prior to randomization: T >100.4 F , Known fetal anomalies
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Whitney You, MD
    Organizational Affiliation
    Northwestern University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    8598837
    Citation
    Hannah ME, Ohlsson A, Farine D, Hewson SA, Hodnett ED, Myhr TL, Wang EE, Weston JA, Willan AR. Induction of labor compared with expectant management for prelabor rupture of the membranes at term. TERMPROM Study Group. N Engl J Med. 1996 Apr 18;334(16):1005-10. doi: 10.1056/NEJM199604183341601.
    Results Reference
    background
    PubMed Identifier
    28257562
    Citation
    Bond DM, Middleton P, Levett KM, van der Ham DP, Crowther CA, Buchanan SL, Morris J. Planned early birth versus expectant management for women with preterm prelabour rupture of membranes prior to 37 weeks' gestation for improving pregnancy outcome. Cochrane Database Syst Rev. 2017 Mar 3;3(3):CD004735. doi: 10.1002/14651858.CD004735.pub4.
    Results Reference
    background
    PubMed Identifier
    25170038
    Citation
    Mackeen AD, Walker L, Ruhstaller K, Schuster M, Sciscione A. Foley catheter vs prostaglandin as ripening agent in pregnant women with premature rupture of membranes. J Am Osteopath Assoc. 2014 Sep;114(9):686-92. doi: 10.7556/jaoa.2014.137.
    Results Reference
    background
    PubMed Identifier
    25845274
    Citation
    Cabrera IB, Quinones JN, Durie D, Rust J, Smulian JC, Scorza WE. Use of intracervical balloons and chorioamnionitis in term premature rupture of membranes. J Matern Fetal Neonatal Med. 2016 Mar;29(6):967-71. doi: 10.3109/14767058.2015.1027191. Epub 2015 Sep 25.
    Results Reference
    background

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    Randomized Control Trial of Intracervical Balloon Placement vs Oxytocin in Women With Term PROM and Unripe Cervices

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