Cervical Ripening With Cook Catheter Plus Low Dose Oxytocin | NCT02465164

Studies
Cervical Ripening With Cook Catheter Plus Low Dose Oxytocin

NCT02465164

Sponsor

Henry Ford Health System

Status

Completed

Last Update Posted

May 22, 2023Actual

Enrollment

26Actual

Phase

Not Applicable

Conditions

Cervical Ripening

Interventions

Cook catheter
Oxytocin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

Participant Flow Module

Pre-assignment Details

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2015Actual

Primary Completion Date

Jul 30, 2016Actual

Completion Date

Jul 30, 2016Actual

First Submitted Date

Jun 3, 2015

First Submission Date that Met QC Criteria

Jun 4, 2015

First Posted Date

Jun 8, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Dec 18, 2022

Results First Submitted that Met QC Criteria

Apr 26, 2023

Results First Posted Date

May 22, 2023Actual

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2023

Last Update Posted Date

May 22, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Justin Bruner, Resident Physician, Henry Ford Health SystemPrincipal Investigator

Lead Sponsor

Henry Ford Health SystemOTHER

Collaborators

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cook catheter	Other	Control	Device: Cook catheter
Cook catheter plus low dose oxytocin	Active Comparator	Test group	Device: Cook catheter Drug: Oxytocin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cook catheter	Device		Cook catheter Cook catheter plus low dose oxytocin
Oxytocin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Arm/Group Information

ID	Title	Description
FG000	Cook Catheter	Control Cook catheter
FG001	Cook Catheter Plus Low Dose Oxytocin	Test group Cook catheter Oxytocin

Baseline Characteristics Module

Baseline Analysis Population Description

Not provided

Type of Units Analyzed

Not provided

Arm/Group Information

ID	Title	Description
BG000	Cook Catheter	Control Cook catheter
BG001	Cook Catheter Plus Low Dose Oxytocin	Test group Cook catheter Oxytocin

Denominators

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Time to Delivery (in Hours)

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

Posted

Median

Full Range

hours

Up to 60 hours

ID	Title	Description
OG000	Cook Catheter	Control Cook catheter
OG001	Cook Catheter Plus Low Dose Oxytocin	Test group Cook catheter Oxytocin

Units	Counts
Participants

Adverse Events Module

Frequency Threshold

Time Frame

Not provided

Description

Not provided

All-Cause Mortality Comment

Not provided

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cook Catheter	Control Cook catheter	0

Serious Adverse Events

Not provided

Other Adverse Events

Not provided

More Info Module

Limitations and Caveats

Not provided

Certain Agreements

Are all PI(s) employees of the sponsor?

Yes

Restriction Type

Point of Contact

Title	Organization	Phone	Extension	Email
Central Clinical Trials Office	Central Clinical Trials Office	3139537454		smarl1@hfhs.org

Intervention Browse Module

MeSH Terms

ID	Term
D010121	Oxytocin

Ancestor Terms

ID	Term
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided