Balloon Catheter for Cervical Ripening
Condition: Cervical Dilation
MeSH terms: Dilatation, Pathologic
Study type: Interventional

Summary: 
      Once admitted, women who will have a transcervical balloon catheter inserted for induction
      will be approached for participation in this study. If they agree to be take part in this
      study (tape or no tape) they will be randomized into the study. After the balloon catheter is
      inserted, the balloon will then be filled with approximately 50-60 mL of normal saline, this
      is normal procedure.

      Study related: If randomized to "No Taping" the foley will be positioned comfortable and not
      placed to tension. For the "Tension" arm, tension will be placed on the balloon catheter,
      which will then be taped to the patient's inner thigh. The tension will be assessed and
      retaped as needed approximately every 30 minutes by the research and/or the nursing staff.
    

Detailed description: 
      Once admitted, women who are schedule for induction and who's physician has order a balloon
      catheter, they will have a transcervical balloon catheter inserted-this is normal care.
      Patients will be placed in the dorsal lithotomy position in the delivery bed. The cervix will
      be examined digitally (this is the standard of care). The balloon catheter will be inserted
      by feel and passed through the cervix until the balloon is above the internal os. The balloon
      will then filled with approximately 50-60 mL of normal saline. This procedure is standard of
      care.

      Randomization: 63 cards will be prepared to read "tape for tension" and 63 will be prepared
      to read "No tape/No Tension". These cards will be sealed in opaque envelopes and kept in the
      PI's office. After consent is obtained the PI will be notified and a sealed envelope will be
      opened and the patient and staff will be notified.

      If randomized to "No tension" the catheter will be positioned comfortable and not placed to
      tension (this is currently the standard at SSM - Saint Mary's Hospital ).

      For the "Tension" arm (research related), slight tension will be placed on the catheter,
      which will then be taped to the patient's inner thigh. The tension will be assessed and
      retaped as needed every 30 minutes by the research and/or the nursing staff.

      Only slight tension will be applied to those catheters assign to the tension group. The
      catheter will be taped to the inner thigh so there is no "sag" in the catheter from the
      urethra to the tape. There is no method or device to "measure" the tension placed on these
      catheters, if the patient moves her leg it can lessen or increase the tension, these are
      known factors.

      As part of the induction process, patients will be started on an infusion of oxytocin, this
      is the practice at SSMHC, unless there is a reason not to use oxytocin such as nonreassuring
      fetal heart tracing. In this situation it is the physician's choice of what to use for
      induction. Oxytocin is initiated at 2 milliunits/minute and increased 1-2 milliunits/minute
      approximately every 20 minutes to a maximum of 6 milliunits/minute while the Foley is in
      place.

      After expulsion of the balloon, the resident or attending physician will performed a cervical
      examination to document the time and the cervical examination, and the oxytocin will be
      titrated to achieve acceptable contraction rates without tachysystole -this is standard care.

      The patient's labor and delivery will be managed according to routine obstetric and
      institutional protocols. All patients will have continuous fetal heart rate and uterine
      activity monitoring.

      Chart review will be performed on both the maternal and infant medical record from admission
      to discharge.
    

Intervention name(s): Slight traction; Foley Catheter to no traction
Intervention type(s): Procedure; Procedure
Intervention description(s): Slight traction will be applied to the balloon catheter; Foley Catheter to no traction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other