Cervical Ripening With a Double-lumen Balloon Catheter for Six Versus Twelve Hours
Condition: Induction of Labor Affected Fetus / Newborn
Study type: Interventional

Summary: 
      The Foley catheter is a safe, effective method for cervical ripening. Limited data exists to
      indicate ideal time of placement for optimal cervical ripening prior to induction. The
      proposed study is a randomized control trial to determine if shortening placement from 12 to
      6 hours of foley catheter can decrease time from start of induction to delivery. The
      prediction is that shortening foley bulb placement will result in shorter induction times,
      increased patient satisfaction and decreased length of stay on labor and delivery with
      secondary decreased medical costs.
    

Detailed description: 
      Objective: To determine whether a double-lumen balloon catheter requires twelve hours in the
      cervical canal to achieve its maximal cervical dilation. It is the hypothesis that the
      maximum cervical dilation and benefits of a double lumen foley catheter are achieved within
      the initial six hours after placement.

      Study Design:

      Overview: All eligible patients with a singleton pregnancy at 37 weeks gestational age or
      greater who are presenting for a clinically/ medically indicated induction with an
      unfavorable cervical exam will be invited to participate. As per the American College of
      Obstetricians and Gynecologists (ACOG) guidelines, all inductions performed prior to 39 weeks
      are medically indicated. Medical indications for induction prior to 39 weeks include but are
      not limited to preeclampsia, oligohydramnios and growth restriction. Upon admission to Labor
      and Delivery, women will be assessed for eligibility by an obstetric physician. A digital
      cervical examination will be performed and a Bishop score assigned. Patients with a Bishop
      score ≤ 6 are thought to benefit from a cervical ripening agent and the participants will be
      randomized based on parity at this point.

      Type of Study: This study will be a prospective, randomized clinical control trial with human
      subjects.

      Materials and Methods:

      A qualified obstetric provider will provide eligible women with details of the study,
      including study objectives and methods. Consent will be obtained and witnessed from patients
      who elect to participate. Enrollment and randomization in the study will then occur. Patients
      will be randomized to the two groups using computer generated random numbers. The
      randomization will be stratified based on parity (i.e., women who have had any prior vaginal
      delivery above 20 weeks gestation v. women who have not). A foley bulb will then be placed by
      a qualified obstetric provider. Foley bulb will be inserted with or without speculum
      technique and with or without use of a stylet. In accordance with the standard of care,
      sterile saline will be placed in the intrauterine and vaginal balloon as tolerated by the
      patient for no more than a maximum of 80 cc in each balloon. The use of concomitant low dose
      pitocin with the foley bulb will be at the discretion of the admitting obstetric team. If the
      patient's foley bulb does not spontaneously expel within the maximum allotted time, they will
      be manually removed at six or twelve hours. At the time of manual removal or expulsion of the
      foley balloon, the patient's cervix will be checked by an experienced obstetric provider. As
      per usual protocol, additional cervical ripening and labor induction will proceed per
      managing obstetric team.

      Independent Variables:

      Data collection will include the independent variables of maternal age, parity, BMI, race
      (Caucasian, African American, Hispanic, Asian, other), Bishop Score, use of magnesium and
      epidural use. Data collection of independent fetal variables will include gestational age and
      estimated fetal weight.

      Outcome Variables:

      The primary outcome will be time from foley bulb placement to time of delivery. Secondary
      outcomes will include time from foley bulb placement to extrusion and rate of cesarean
      section. Additional comparison variables include: neonatal weight, APGAR scores and
      intrapartum and postpartum infection rates.
    

Intervention name(s): Double-lumen balloon catheter
Intervention type(s): Device
Intervention description(s): introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
Other intervention name(s): foley bulb
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cervical ripening; double lumen catheter