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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Catheter to slight traction | Active Comparator | 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. |
|
| Group 2 Catheter to no traction | Active Comparator | Foley catheter to no traction placed as SOC "No traction" applied |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Slight traction | Procedure | Slight traction will be applied to the balloon catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration | Hours of labor | hours to delivery 0-26 |
| Measure | Description | Time Frame |
|---|---|---|
| Deliveries Via Cesarean Delivery | What number of deliveries in the tension and no tension groups were via Cesarean delivery | intraoperative |
| Vaginal Delivery Within 24 Hours | vaginal delivery within 24 hours-not all deliveries were within 24hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Fruhman, MD | St. Louis University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Mary's Health Center | St Louis | Missouri | 63117 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36996264 | Derived | de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 Catheter to Slight Traction | 68 patients were analyzed in the tension group |
| FG001 | Group 2 Catheter to no Traction | 76 patients were analyzed in the no tension group |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 Catheter to Slight Traction | Once the decision was made to use a transcervical catheter and the patient was not in labor, the patient was approached. After informed consent was obtained from each participant, an 18 French 30 cc Foley bulb was placed digitally by the housestaff, with or without a stylette. The balloon was filled with 50 cc of saline as this is the standard at our institution. Patients randomized to tension had their catheter taped with applied tension to the inner thigh. Tension was replaced approximately every 30 minutes as needed. If the catheter was not expelled after12 hours, the balloon was deflated and the catheter was removed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration | Hours of labor | an alpha level of .05, and a level of power of 80%. These parameters required a sample size of 63 patients per group | Posted | Mean | Full Range | hours | hours to delivery 0-26 |
|
6 months post delivery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | Slight Tension |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary Furhman | Saint Louis University | 314-977-2090 | jathompson@slu.edu |
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| Foley Catheter to no traction | Procedure | Foley Catheter to no traction |
|
| 24 hours |
| BG001 | Group 2 Catheter to no Traction | Once the decision was made to use a transcervical catheter and the patient was not in labor, the patient was approached. After informed consent was obtained from each participant, an 18 French 30 cc Foley bulb was placed digitally by the housestaff, with or without a stylette. The balloon was filled with 50 cc of saline as this is the standard at our institution. Patients randomized to no tension did not have any tension applied to their catheter. After randomization clinicians were not blinded to the allocated group. If the catheter was not expelled after12 hours, the balloon was deflated and the catheter was removed. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | 11 participants failed screening and were not included in analysis | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Gestational age at enrollment (wk | Mean | Full Range | weeks |
|
| Body mass index at admission | Body mass index at admission (kg/m^2) | Mean | Full Range | kg/m2 |
|
| Bishop score at time of transcervical | A women with a low score of 1 would not expected go into labor for about 3 weeks. A woman with a higher score score of 10 could be expected to go into labor within a few days. | Mean | Full Range | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Deliveries Via Cesarean Delivery | What number of deliveries in the tension and no tension groups were via Cesarean delivery | Posted | Number | participants | intraoperative |
|
|
|
| Secondary | Vaginal Delivery Within 24 Hours | vaginal delivery within 24 hours-not all deliveries were within 24hours | Twenty four hour Vaginal delivery between groups | Posted | Number | participants | 24 hours |
|
|
|
| 0 |
| 67 |
| 0 |
| 67 |
| EG001 | Group 2 | no Tension | 0 | 73 | 0 | 73 |
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