Balloon Catheter for Cervical Ripening

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.

Inclusion Criteria:

- singleton gestation

- Bishop score less than or equal to 6

- cephalic presentation

Exclusion Criteria:

- prostaglandins given this admission

- any medical conditions precluding vaginal delivery

- significant cervical or intrauterine infection

- significant vaginal bleeding

- intrauterine fetal demise

- low lying placenta

- prior cervical surgery

- latex allergy