NCT04233008

Length of Cook Catheter Placement and Induction of Labor

Completed NA Results posted Last updated 24 June 2022

What this trial tests

NA trial testing Foley catheter length in Induction of Labor in 178 participants. Completed in 1 July 2020.

Timeline

1 January 2019

Primary endpoint
1 July 2020

1 July 2020

Quick facts

Lead sponsor	Brigham and Women's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	178
Start date	1 January 2019
Primary completion	1 July 2020
Estimated completion	1 July 2020
Sites	1 location across United States

Drugs / interventions tested

• Foley catheter length

Conditions studied

• Induction of Labor — all drugs for Induction of Labor →

Sponsor

Brigham and Women's Hospital

Who can join

Adults 18 to 50, female only, with Induction of Labor. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time to Delivery Primary · Assessed following delivery (delivery day, day 0)

Time to delivery

Group	Value	95% CI
6 Hour Foley	19.2	13.9 – 28
12 Hour Foley	24.3	15.6 – 32

Cesarean Delivery Rate Secondary · Assessed following delivery (delivery day, day 0)

Cesarean delivery rate

Group	Value	95% CI
6 Hour Foley	17
12 Hour Foley	25

Time to Active Labor Secondary · Assessed following delivery (delivery day, day 0)

Time to reaching active labor (defined as 5cm)

Group	Value	95% CI
6 Hour Foley	10.5	8.1 – 16.2
12 Hour Foley	15.9	10.7 – 23

Delivery Within 12 Hours Secondary · Assessed following delivery (delivery day, day 0)

The number of women in each group who deliver within 12 hours

Group	Value	95% CI
6 Hour Foley	14
12 Hour Foley	9

Delivery Within 24 Hours Secondary · Assessed following delivery (delivery day, day 0)

The number of women in each group who deliver within 24 hours

Group	Value	95% CI
6 Hour Foley	60
12 Hour Foley	42

Maternal Length of Stay Secondary · Assessed at end of study period (week 4)

Length of hospital stay from start of induction to postpartum discharge

Group	Value	95% CI
6 Hour Foley	2	2 – 3
12 Hour Foley	2	2 – 3.5

Indication for Cesarean Delivery Secondary · Assessed following delivery (delivery day, day 0)

Number of Patient with Indication for Cesarean Delivery

Group	Value	95% CI
6 Hour Foley	10
12 Hour Foley	11

Maternal Complications Secondary · Assessed at end of study period (week 4)

Estimated blood loss, blood transfusion, higher order laceration, endometritis, wound infection, venous thromboembolism, hysterectomy, ICU admission, maternal death

Postpartum hemorrage

Group	Value	95% CI
6 Hour Foley	7
12 Hour Foley	8

Higher order laceration

Group	Value	95% CI
6 Hour Foley	7
12 Hour Foley	2

Wound infection

Group	Value	95% CI
6 Hour Foley	1
12 Hour Foley	1

Endometritis

Group	Value	95% CI
6 Hour Foley	1
12 Hour Foley	1

chorioamnionitis

Group	Value	95% CI
6 Hour Foley	13
12 Hour Foley	11

Neonatal Complications Secondary · Assessed at end of study period (week 4)

culture-proven neonatal sepsis, neonatal blood transfusion, hypoxic-ischemic encephalopathy, intraventricular hemorrhage grade 3 or 4, or therapeutic hypothermia

Group	Value	95% CI
6 Hour Foley	0
12 Hour Foley	0

NICU Admission Secondary · Assessed at end of study period (week 4)

Number of infants admitted to NICU

Group	Value	95% CI
6 Hour Foley	9
12 Hour Foley	6

NICU Admission >48 Hours Secondary · Assessed at end of study period (week 4)

Number of infants admitted to NICU for \>48 hours

Group	Value	95% CI
6 Hour Foley	4
12 Hour Foley	2

Neonatal Length of Stay Secondary · Assessed at end of study period (week 4)

Days of hospital stay

Group	Value	95% CI
6 Hour Foley	2	2 – 4
12 Hour Foley	2	2 – 4

Sponsor's own description

The goal of this study is to compare cook catheter placement for 6 vs. 12 hours to see if there is faster time to delivery for people admitted to labor and delivery undergoing induction of labor.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.