N/A
N=144
Balloon Catheter for Cervical Ripening
Cervical Dilation
Bottom Line
View on ClinicalTrials.gov: NCT02606643 ↗Enrolled (actual)
144
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Duration — 16.2; 16.9 hours — p=0.814
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Slight traction (Procedure); Foley Catheter to no traction (Procedure)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- Female
- Sponsor
- St. Louis University
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration |
16.2; 16.9 | 0.814 |
| SECONDARY Deliveries Via Cesarean Delivery |
17; 27 | — |
| SECONDARY Vaginal Delivery Within 24 Hours |
41; 37 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02606643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.