Trial Outcomes & Findings for Bladder Drainage During Labor: A Randomized Controlled Study of Obstetric Foley Therapy (NCT NCT00959920)

Results Overview

Time to delivery defined as IV placement to delivery of infant.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

139 participants

Primary outcome timeframe

1 day

Results posted on

2017-05-19

Participant Flow

Participants were enrolled 7/09-11/09 from the obstetric units of the Loyola University Health System hospitals. Subjects included adult women with a singleton pregnancy who presented to the Labor \& Deliver in active labor or for induction, were anticipated to have an normal spontaneous vaginal delivery (NSVD), and had an epidural.

Every patient was assigned to a group immediately following enrollment.

Participant milestones

Participant milestones
Measure	Indwelling Foley Catheter Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.	Intermittent Straight Catheterization Intermittent straight catheterization will be performed as needed during labor.
Overall Study STARTED	72	67
Overall Study COMPLETED	72	66
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bladder Drainage During Labor: A Randomized Controlled Study of Obstetric Foley Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Indwelling Foley Catheter n=72 Participants Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.	Intermittent Straight Catheterization n=67 Participants Intermittent straight catheterization will be performed as needed during labor.	Total n=139 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	72 Participants n=5 Participants	67 Participants n=7 Participants	139 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	27.6 years STANDARD_DEVIATION 6 • n=5 Participants	28.7 years STANDARD_DEVIATION 6 • n=7 Participants	28.14 years STANDARD_DEVIATION 6.13 • n=5 Participants
Sex: Female, Male Female	72 Participants n=5 Participants	67 Participants n=7 Participants	139 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	72 participants n=5 Participants	67 participants n=7 Participants	139 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Population: Our a priori sample size required 138 women (69 per group) for 80% power to detect the clinically relevant 30 minute difference in the time to delivery interval with a .05 alpha error.

Time to delivery defined as IV placement to delivery of infant.

Outcome measures

Outcome measures
Measure	Indwelling Foley Catheter n=72 Participants Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.	Intermittent Straight Catheterization n=66 Participants Intermittent straight catheterization will be performed as needed during labor.
Time to Delivery (by Any Route)	10.43 Hours Interval 5.52 to 15.34	11.23 Hours Interval 7.15 to 15.31

SECONDARY outcome

Timeframe: End of study.

Population: No formal statistical testing was conducted on these measures as complete financial records were not available for the analysis.

Cost of the intermittent vs. foley catheterization procedures was measured and reported in mean dollars.

Outcome measures

Outcome data not reported

Adverse Events

Indwelling Foley Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intermittent Straight Catheterization

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

Dr. Sarita Massey

Loyola University Medical Center

Phone: 708-354-9250

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place