Trial Outcomes & Findings for Foley Catheter for Labor Induction in Women With Term and Near Term Membrane Rupture (NCT NCT00290199)

NCT ID: NCT00290199

Last Updated: 2017-05-23

Results Overview

The outcome measure is the mean in hours of the time from induction to delivery (up to 24 hours)

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 169 participants
• Primary outcome timeframe: Time from induction to delivery
• Results posted on: 2017-05-23

Participant Flow

Participant milestones

Measure	Transcervical Foley Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin	No Foley No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
Overall Study STARTED	87	82
Overall Study COMPLETED	87	82
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Foley Catheter for Labor Induction in Women With Term and Near Term Membrane Rupture

Baseline characteristics by cohort

Measure	Transcervical Foley n=87 Participants Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin	No Foley n=82 Participants No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin	Total n=169 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	87 Participants n=93 Participants	82 Participants n=4 Participants	169 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	25 years STANDARD_DEVIATION 5 • n=93 Participants	25 years STANDARD_DEVIATION 6 • n=4 Participants	25 years STANDARD_DEVIATION 5.5 • n=27 Participants
Sex: Female, Male Female	87 Participants n=93 Participants	82 Participants n=4 Participants	169 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	87 participants n=93 Participants	82 participants n=4 Participants	169 participants n=27 Participants

PRIMARY outcome

Timeframe: Time from induction to delivery

The outcome measure is the mean in hours of the time from induction to delivery (up to 24 hours)

Outcome measures

Measure	Transcervical Foley n=79 Participants Insertion of a a transcervical foley catheter to induce labor	No Foley n=73 Participants No transcervical foley catheter inserted to induce labor
Hours From Placement of Foley or Initiation of Oxytocin to Delivery	10.8 hours Standard Deviation NA Due to PI no longer with institution, data not available	12.1 hours Standard Deviation NA Due to PI no longer with institution, data not available.

SECONDARY outcome

Timeframe: from start of induction to 24 hours post start of induction

The percent of subjects having transcervical foley catheter and percent of subjects not having transcervical foley catheter delivering within 24 hours.

Outcome measures

Measure	Transcervical Foley n=79 Participants Insertion of a a transcervical foley catheter to induce labor	No Foley n=73 Participants No transcervical foley catheter inserted to induce labor
Rate of Delivery (Vaginal or Cesarean)by 24 Hours	96 percentage of deliveries	97 percentage of deliveries

SECONDARY outcome

Timeframe: at delivery

The percent of subjects enrolled who had a cesarean at any time for any reason for delivery.

Outcome measures

Measure	Transcervical Foley n=79 Participants Insertion of a a transcervical foley catheter to induce labor	No Foley n=73 Participants No transcervical foley catheter inserted to induce labor
Cesarean Rate	14 percentage of subjects	23 percentage of subjects

SECONDARY outcome

Timeframe: time from induction to vaginal delivery, up to 24 hours

Mean hours from time of induction to vaginal delivery interval.

Outcome measures

Measure	Transcervical Foley n=68 Participants Insertion of a a transcervical foley catheter to induce labor	No Foley n=56 Participants No transcervical foley catheter inserted to induce labor
Induction to Vaginal Delivery Interval	10.7 hours Standard Deviation NA Due to PI no longer with institution, data available.	11.6 hours Standard Deviation NA Due to PI no longer with institution, data not available.

Adverse Events

Transcervical Foley

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Foley

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. Alan Tita

UAB

Phone: 205-934-9616

Email: atita@uab.edu

Results disclosure agreements

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