Cervical Dilation Clinical Trial
— 25148Official title:
Balloon Catheter for Cervical Ripening With or Without Traction: A Randomized Controlled Trial
NCT number | NCT02606643 |
Other study ID # | StLouisU |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2014 |
Est. completion date | November 2016 |
Verified date | February 2018 |
Source | St. Louis University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 134 |
Est. completion date | November 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 14 Years to 55 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | St. Mary's Health Center | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
St. Louis University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration | Hours of labor | hours to delivery 0-26 | |
Secondary | Deliveries Via Cesarean Delivery | What number of deliveries in the tension and no tension groups were via Cesarean delivery | intraoperative | |
Secondary | Vaginal Delivery Within 24 Hours | vaginal delivery within 24 hours-not all deliveries were within 24hours | 24 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
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