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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03172858
Recruitment Status : Not yet recruiting
First Posted : June 1, 2017
Last Update Posted : June 14, 2017
Information provided by (Responsible Party):
Whitney You, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Premature Rupture of Membrane Unfavorable Cervix Device: Intracervical balloon catheter Drug: Oxytocin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Intracervical Balloon Placement Versus Intravenous Oxytocin in Women With Premature Rupture of Membranes and Unripe Cervices
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Intracervical Balloon Catheter Group

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.

Device: Intracervical balloon catheter
cervical ripening balloon

Drug: Oxytocin
medication used to induce contractions

Active Comparator: Immediate low-dose oxytocin infusion group
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.
Drug: Oxytocin
medication used to induce contractions

Primary Outcome Measures :
  1. Time from start of induction defined as time of IBC (intracervical balloon catheter) placement or initiation of oxytocin until delivery in hours [ Time Frame: 24-48 hours/duration of induction of labor ]
    length of induction

Secondary Outcome Measures :
  1. Length of first stage of labor [ Time Frame: delivery (from initial cervical dilation to 10 cm cervical dilation]) ]
    length of first stage of labor

  2. Cesarean delivery rate [ Time Frame: 24-48 hours/duration of induction of labor ]
    number of cesarean deliveries

  3. chorioamnionitis [ Time Frame: 24-48 hours/duration of induction of labor ]
    Maternal temperature >100.4 F during labor with associated maternal or fetal tachycardia

  4. Endometritis [ Time Frame: from time of delivery until 2 days after delivery for vaginal deliveries and 3 days after delivery for cesarean sections ]
    temperature >100.4 F in the postpartum period with initiation of antibiotics in postpartum period

  5. Postpartum hemorrhage [ Time Frame: at time of delivery and up to 24 hours after delivery ]
    Estimated blood loss (EBL) >500 cc from a vaginal delivery and EBL >1000 cc from a cesarean delivery

  6. Epidural use [ Time Frame: 24-48 hours/duration of induction of labor ]
    epidural anesthesia use during labor

  7. Neonatal 5-minute Apgar score [ Time Frame: 5 minutes after delivery ]
    apgar score at 5 minutes of life after delivery of neonate

  8. Neonatal umbilical arterial and venous acid base status [ Time Frame: at the time of delivery ]
    assessment of acid-base status of neonate at the time of delivery

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnancy
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03172858

Sponsors and Collaborators
Northwestern University
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Principal Investigator: Whitney You, MD Northwestern University

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Responsible Party: Whitney You, Assistant Professor, Northwestern University Identifier: NCT03172858     History of Changes
Other Study ID Numbers: STU00203535
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Whitney You, Northwestern University:
cervical ripening
term premature rupture of membrane
intracervical balloon catheter
Additional relevant MeSH terms:
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Premature Birth
Fetal Membranes, Premature Rupture
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries
Reproductive Control Agents
Physiological Effects of Drugs