Clinical trial NCT02606643: Balloon Catheter for Cervical Ripening
Official title: Balloon Catheter for Cervical Ripening With or Without Traction: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Dilation
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2015-11-17
Enrollment: 134
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration
timeFrame: hours to delivery 0-26
Secondary outcomes:
measure: Deliveries Via Cesarean Delivery
timeFrame: intraoperative
measure: Vaginal Delivery Within 24 Hours
timeFrame: 24 hours
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: St. Mary's Health Center
state: Missouri
Study officials:
affiliation: St. Louis University
name: Gary Fruhman, MD
role: PRINCIPAL_INVESTIGATOR
References: