Trials / Completed
CompletedNCT02465164
Cervical Ripening With Cook Catheter Plus Low Dose Oxytocin
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Henry Ford Health System · Academic / Other
- Sex
- Female
- Age
- 16 Years – 40 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cook catheter | |
| DRUG | Oxytocin |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2016-07-30
- Completion
- 2016-07-30
- First posted
- 2015-06-08
- Last updated
- 2023-05-22
- Results posted
- 2023-05-22
Source: ClinicalTrials.gov record NCT02465164. Inclusion in this directory is not an endorsement.