Trial Outcomes & Findings for Cervical Ripening With Cook Catheter Plus Low Dose Oxytocin (NCT NCT02465164)

NCT ID: NCT02465164

Last Updated: 2023-05-22

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 26 participants
• Primary outcome timeframe: Up to 60 hours
• Results posted on: 2023-05-22

Participant Flow

Participant milestones

Measure	Cook Catheter Control Cook catheter	Cook Catheter Plus Low Dose Oxytocin Test group Cook catheter Oxytocin
Overall Study STARTED	16	10
Overall Study COMPLETED	16	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cervical Ripening With Cook Catheter Plus Low Dose Oxytocin

Baseline characteristics by cohort

Measure	Cook Catheter n=16 Participants Control Cook catheter	Cook Catheter Plus Low Dose Oxytocin n=10 Participants Test group Cook catheter Oxytocin	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	10 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	22 years STANDARD_DEVIATION 1.2 • n=5 Participants	24 years STANDARD_DEVIATION 1.3 • n=7 Participants	23 years STANDARD_DEVIATION 1.2 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	10 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	9 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	16 Participants n=5 Participants	10 Participants n=7 Participants	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 60 hours

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

Outcome measures

Measure	Cook Catheter n=16 Participants Control Cook catheter	Cook Catheter Plus Low Dose Oxytocin n=10 Participants Test group Cook catheter Oxytocin
Time to Delivery (in Hours)	27 hours Interval 12.0 to 54.0	23 hours Interval 7.0 to 33.0

Adverse Events

Cook Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cook Catheter Plus Low Dose Oxytocin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Central Clinical Trials Office

Central Clinical Trials Office

Phone: 3139537454

Email: smarl1@hfhs.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place