Trial Outcomes & Findings for Length of Cook Catheter Placement and Induction of Labor (NCT NCT04233008)
NCT ID: NCT04233008
Last Updated: 2022-06-24
Results Overview
Time to delivery
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
178 participants
Primary outcome timeframe
Assessed following delivery (delivery day, day 0)
Results posted on
2022-06-24
Participant Flow
Participant milestones
| Measure |
6 Hour Foley
The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 6 hours, determined by randomization. At that point health care providers will manage active labor.
Foley catheter length: see arm description
|
12 Hour Foley
The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 12 hours, determined by randomization. At that point health care providers will manage active labor.
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
89
|
|
Overall Study
COMPLETED
|
89
|
89
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Length of Cook Catheter Placement and Induction of Labor
Baseline characteristics by cohort
| Measure |
6 Hour Foley
n=89 Participants
Foley for up to 6 hours
|
12 Hour Foley
n=88 Participants
Foley up to 12 hours
|
Total
n=177 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.2 years
n=5 Participants
|
31.4 years
n=7 Participants
|
31.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · white
|
43 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Latinx
|
20 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Nulliparous
|
71 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
BMI
|
30.1 kg/m2
n=5 Participants
|
31.8 kg/m2
n=7 Participants
|
31.0 kg/m2
n=5 Participants
|
|
Gestational Age
|
39 Weeks
n=5 Participants
|
39 Weeks
n=7 Participants
|
39 Weeks
n=5 Participants
|
|
Bishop score at randomization
|
2 units on a scale
n=5 Participants
|
2 units on a scale
n=7 Participants
|
2 units on a scale
n=5 Participants
|
|
Birthweight (g)
|
3200 grams
n=5 Participants
|
3149 grams
n=7 Participants
|
3175 grams
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed following delivery (delivery day, day 0)Time to delivery
Outcome measures
| Measure |
6 Hour Foley
n=89 Participants
The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 6 hours, determined by randomization. At that point health care providers will manage active labor.
Foley catheter length: see arm description
|
12 Hour Foley
n=88 Participants
The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 12 hours, determined by randomization. At that point health care providers will manage active labor.
|
|---|---|---|
|
Time to Delivery
|
19.2 hours
Interval 13.9 to 28.0
|
24.3 hours
Interval 15.6 to 32.0
|
SECONDARY outcome
Timeframe: Assessed following delivery (delivery day, day 0)Cesarean delivery rate
Outcome measures
| Measure |
6 Hour Foley
n=89 Participants
The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 6 hours, determined by randomization. At that point health care providers will manage active labor.
Foley catheter length: see arm description
|
12 Hour Foley
n=88 Participants
The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 12 hours, determined by randomization. At that point health care providers will manage active labor.
|
|---|---|---|
|
Cesarean Delivery Rate
|
17 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Assessed following delivery (delivery day, day 0)Time to reaching active labor (defined as 5cm)
Outcome measures
| Measure |
6 Hour Foley
n=85 Participants
The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 6 hours, determined by randomization. At that point health care providers will manage active labor.
Foley catheter length: see arm description
|
12 Hour Foley
n=82 Participants
The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 12 hours, determined by randomization. At that point health care providers will manage active labor.
|
|---|---|---|
|
Time to Active Labor
|
10.5 hours
Interval 8.1 to 16.2
|
15.9 hours
Interval 10.7 to 23.0
|
SECONDARY outcome
Timeframe: Assessed following delivery (delivery day, day 0)The number of women in each group who deliver within 12 hours
Outcome measures
| Measure |
6 Hour Foley
n=89 Participants
The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 6 hours, determined by randomization. At that point health care providers will manage active labor.
Foley catheter length: see arm description
|
12 Hour Foley
n=88 Participants
The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 12 hours, determined by randomization. At that point health care providers will manage active labor.
|
|---|---|---|
|
Delivery Within 12 Hours
|
14 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Assessed following delivery (delivery day, day 0)The number of women in each group who deliver within 24 hours
Outcome measures
| Measure |
6 Hour Foley
n=89 Participants
The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 6 hours, determined by randomization. At that point health care providers will manage active labor.
Foley catheter length: see arm description
|
12 Hour Foley
n=88 Participants
The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 12 hours, determined by randomization. At that point health care providers will manage active labor.
|
|---|---|---|
|
Delivery Within 24 Hours
|
60 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: Assessed at end of study period (week 4)Length of hospital stay from start of induction to postpartum discharge
Outcome measures
| Measure |
6 Hour Foley
n=89 Participants
The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 6 hours, determined by randomization. At that point health care providers will manage active labor.
Foley catheter length: see arm description
|
12 Hour Foley
n=88 Participants
The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 12 hours, determined by randomization. At that point health care providers will manage active labor.
|
|---|---|---|
|
Maternal Length of Stay
|
2 days
Interval 2.0 to 3.0
|
2 days
Interval 2.0 to 3.5
|
SECONDARY outcome
Timeframe: Assessed following delivery (delivery day, day 0)Number of Patient with Indication for Cesarean Delivery
Outcome measures
| Measure |
6 Hour Foley
n=17 Participants
The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 6 hours, determined by randomization. At that point health care providers will manage active labor.
Foley catheter length: see arm description
|
12 Hour Foley
n=25 Participants
The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 12 hours, determined by randomization. At that point health care providers will manage active labor.
|
|---|---|---|
|
Indication for Cesarean Delivery
|
10 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
6 Hour Foley
n=89 Participants
The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 6 hours, determined by randomization. At that point health care providers will manage active labor.
Foley catheter length: see arm description
|
12 Hour Foley
n=88 Participants
The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 12 hours, determined by randomization. At that point health care providers will manage active labor.
|
|---|---|---|
|
Maternal Complications
Postpartum hemorrage
|
7 Participants
|
8 Participants
|
|
Maternal Complications
Higher order laceration
|
7 Participants
|
2 Participants
|
|
Maternal Complications
Wound infection
|
1 Participants
|
1 Participants
|
|
Maternal Complications
Endometritis
|
1 Participants
|
1 Participants
|
|
Maternal Complications
chorioamnionitis
|
13 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
6 Hour Foley
n=89 Participants
The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 6 hours, determined by randomization. At that point health care providers will manage active labor.
Foley catheter length: see arm description
|
12 Hour Foley
n=88 Participants
The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 12 hours, determined by randomization. At that point health care providers will manage active labor.
|
|---|---|---|
|
Neonatal Complications
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed at end of study period (week 4)Number of infants admitted to NICU
Outcome measures
| Measure |
6 Hour Foley
n=89 Participants
The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 6 hours, determined by randomization. At that point health care providers will manage active labor.
Foley catheter length: see arm description
|
12 Hour Foley
n=88 Participants
The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 12 hours, determined by randomization. At that point health care providers will manage active labor.
|
|---|---|---|
|
NICU Admission
|
9 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Assessed at end of study period (week 4)Number of infants admitted to NICU for \>48 hours
Outcome measures
| Measure |
6 Hour Foley
n=89 Participants
The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 6 hours, determined by randomization. At that point health care providers will manage active labor.
Foley catheter length: see arm description
|
12 Hour Foley
n=88 Participants
The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 12 hours, determined by randomization. At that point health care providers will manage active labor.
|
|---|---|---|
|
NICU Admission >48 Hours
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Assessed at end of study period (week 4)Days of hospital stay
Outcome measures
| Measure |
6 Hour Foley
n=89 Participants
The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 6 hours, determined by randomization. At that point health care providers will manage active labor.
Foley catheter length: see arm description
|
12 Hour Foley
n=88 Participants
The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 12 hours, determined by randomization. At that point health care providers will manage active labor.
|
|---|---|---|
|
Neonatal Length of Stay
|
2 days
Interval 2.0 to 4.0
|
2 days
Interval 2.0 to 4.0
|
Adverse Events
6 Hour Foley - Mothers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
12 Hour Foley - Mothers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
6 Hour Foley - Neonates
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
12 Hour Foley - Neonates
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place