Cervical Ripening With Cook Catheter Plus Low Dose Oxytocin

NCT02465164 | Completed Results

• 1 other identifier: HFM 2900
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cervical Ripening

Outcome Measures

Primary Outcomes (1)

• Time to Delivery (in Hours)

  Cook Only group Cook + Pitocin group N Mean (hrs) (SD) 16 27.9 (9.6) 10 23 14.6)

  Up to 60 hours

Study Arms (2)

Cook catheter

OTHER

Control

Device: Cook catheter

Cook catheter plus low dose oxytocin

ACTIVE COMPARATOR

Test group

Device: Cook catheter; Drug: Oxytocin

Interventions

Cook catheter DEVICE

Cook catheter; Cook catheter plus low dose oxytocin

Oxytocin DRUG

Cook catheter plus low dose oxytocin

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• singleton pregnancy
• reassuring fetal status at time of presentation
• Bishop Score \<6

You may not qualify if:

• Closed cervix
• Breech presentation
• Multiple gestations
• Recent vaginal bleeding
• Placenta previa
• non reassuring fetal status
• Active genital herpes infection

Sponsors & Collaborators

• Henry Ford Health System: lead

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Central Clinical Trials Office
• Organization: Central Clinical Trials Office

smarl1@hfhs.org

3139537454

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 8, 2015
• Study Start: July 1, 2015
• Primary Completion: July 30, 2016
• Study Completion: July 30, 2016
• Last Updated: May 22, 2023
• Results First Posted: May 22, 2023

Record last verified: 2023-04