Cervical Ripening With Cook Catheter Plus Low Dose Oxytocin

Not Applicable

Completed

• Conditions: Cervical Ripening
• Interventions: Device: Cook catheter; Drug: Oxytocin

• Registration Number: NCT02465164
• Lead Sponsor: Henry Ford Health System

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-06-04
• Study First Posted: 2015-06-08
• Study Start: 2015-07-01
• Primary Completion: 2016-07-30
• Study Completion: 2016-07-30
• Results First Submitted: 2022-12-18
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-26
• Last Update Submitted: 2023-04-26
• Results First Posted: 2023-05-22
• Last Update Posted: 2023-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

Inclusion Criteria

1. singleton pregnancy
2. reassuring fetal status at time of presentation
3. Bishop Score <6

Exclusion Criteria

1. Closed cervix
2. Breech presentation
3. Multiple gestations
4. Recent vaginal bleeding
5. Placenta previa
6. non reassuring fetal status
7. Active genital herpes infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cook catheter	Cook catheter	Control
Cook catheter plus low dose oxytocin	Oxytocin	Test group
Cook catheter plus low dose oxytocin	Cook catheter	Test group

Primary Outcome Measures

Name	Time	Method
Time to Delivery (in Hours)	Up to 60 hours	Cook Only group Cook + Pitocin group N Mean (hrs) (SD) 16 27.9 (9.6) 10 23 14.6)