N/A
N=26
Cervical Ripening With Cook Catheter Plus Low Dose Oxytocin
Cervical Ripening
Bottom Line
View on ClinicalTrials.gov: NCT02465164 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Time to Delivery (in Hours) — 27; 23 hours — p=0.208
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cook catheter (Device); Oxytocin (Drug)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- Female
- Sponsor
- Henry Ford Health System
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Delivery (in Hours) |
27; 23 | 0.208 |
Summary
The purpose of this study is to compare if using a Cook Cervical Ripening Balloon in conjunction with low dose oxytocin is more effective at shortening labor induction times than the Cook Cervical Ripening Balloon alone. After obtaining consent, patients will be randomly divided into a Balloon with oxytocin or Balloon only group. The Balloon will be placed by either Resident or Attending Physicians and left in place for 12 hours (protocol) in both groups or until it falls out. After either 12 hours or the Balloon falls out, oxytocin will be used for the remainder of the induction per current hospital protocol. Time to delivery, mode of delivery, average number of hours Balloon remained in place, non-reassuring fetal heart tracings, adverse outcomes (ie fetal malpresentation, postpartum hemorrhage) will be recorded.
Eligibility Criteria
Inclusion Criteria
- singleton pregnancy
- reassuring fetal status at time of presentation
- Bishop Score <6
Exclusion Criteria
- Closed cervix
- Breech presentation
- Multiple gestations
- Recent vaginal bleeding
- Placenta previa
- non reassuring fetal status
- Active genital herpes infection
Data sourced from ClinicalTrials.gov (NCT02465164). 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.