Length of Cook Catheter Placement and Induction of Labor

Length of Cook Catheter Placement and Induction of Labor: a Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04233008

Enrollment

178

Registered

2020-01-18

Start date

2019-01-01

Completion date

2020-07-01

Last updated

2022-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induction of Labor

Keywords

Maternal outcomes, Neonatal Outcomes

Brief summary

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.

Detailed description

Upon presentation to labor and delivery the participant will have a cook catheter inserted digitally or by direct visualization with a speculum. The uterine component of the balloon will be inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. In both groups participants will be started on hospital-based oxytocin protocol. This protocol beings with 2 milliunits/min of oxytocin, increasing by 2 milliunits every 15 minutes until regular uterine contractions occur. The maximum dose of oxytocin is considered to be 30 milliunits. The cook catheter will then be removed at 6 vs. 12 hours based on randomization. At that point health care providers will manage active labor. Health care providers many perform amniotomy at any point during the induction process with recommendation for amniotomy with cervix more than 4cm dilated. Labor interventions are at the discretion of the healthcare provider. The participants will have continuous fetal monitoring throughout their induction, labor and delivery. Need for operative delivery or cesarean section will be at the discretion of the health provider.

Interventions

DEVICEFoley catheter length

see arm description

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

Women undergoing cervical ripening for labor induction at term (37-41 6/7 weeks) with a singleton gestation in cephalic presentation. Women will need to have a bishop score \<6 or cervical dilation \<2cm with intact membranes to be included.

Exclusion criteria

* Non English speaking * Contraindications to vaginal delivery * Prior cesarean section

Design outcomes

Primary

Measure	Time frame	Description
Time to Delivery	Assessed following delivery (delivery day, day 0)	Time to delivery

Secondary

Measure	Time frame	Description
Maternal Length of Stay	Assessed at end of study period (week 4)	Length of hospital stay from start of induction to postpartum discharge
Cesarean Delivery Rate	Assessed following delivery (delivery day, day 0)	Cesarean delivery rate
Time to Active Labor	Assessed following delivery (delivery day, day 0)	Time to reaching active labor (defined as 5cm)
Delivery Within 12 Hours	Assessed following delivery (delivery day, day 0)	The number of women in each group who deliver within 12 hours
Indication for Cesarean Delivery	Assessed following delivery (delivery day, day 0)	Number of Patient with Indication for Cesarean Delivery
Delivery Within 24 Hours	Assessed following delivery (delivery day, day 0)	The number of women in each group who deliver within 24 hours
Neonatal Complications	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
NICU Admission	Assessed at end of study period (week 4)	Number of infants admitted to NICU
NICU Admission >48 Hours	Assessed at end of study period (week 4)	Number of infants admitted to NICU for \>48 hours
Neonatal Length of Stay	Assessed at end of study period (week 4)	Days of hospital stay
Maternal Complications	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

Countries

United States

Participant flow

Participants by arm

Arm	Count
6 Hour Foley Foley for up to 6 hours	89
12 Hour Foley Foley up to 12 hours	88
Total	177

Baseline characteristics

Characteristic	6 Hour Foley	12 Hour Foley	Total
Age, Continuous	31.2 years	31.4 years	31.3 years
Birthweight (g)	3200 grams	3149 grams	3175 grams
Bishop score at randomization	2 units on a scale	2 units on a scale	2 units on a scale
BMI	30.1 kg/m2	31.8 kg/m2	31.0 kg/m2
Gestational Age	39 Weeks	39 Weeks	39 Weeks
Nulliparous	71 Participants	68 Participants	139 Participants
Race/Ethnicity, Customized Race/Ethnicity Asian	8 Participants	6 Participants	14 Participants
Race/Ethnicity, Customized Race/Ethnicity Black	16 Participants	18 Participants	34 Participants
Race/Ethnicity, Customized Race/Ethnicity Latinx	20 Participants	12 Participants	32 Participants
Race/Ethnicity, Customized Race/Ethnicity Other	2 Participants	0 Participants	2 Participants
Race/Ethnicity, Customized Race/Ethnicity white	43 Participants	52 Participants	95 Participants
Sex: Female, Male Female	89 Participants	88 Participants	177 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 89	0 / 89	0 / 89	0 / 89
other Total, other adverse events	0 / 89	0 / 89	0 / 89	0 / 89
serious Total, serious adverse events	0 / 89	0 / 89	0 / 89	0 / 89

Outcome results

Primary

Time to Delivery

Time to delivery

Time frame: Assessed following delivery (delivery day, day 0)

Arm	Measure	Value (MEDIAN)
6 Hour Foley	Time to Delivery	19.2 hours
12 Hour Foley	Time to Delivery	24.3 hours

p-value: 0.04Wilcoxon (Mann-Whitney)

Secondary

Cesarean Delivery Rate

Cesarean delivery rate

Time frame: Assessed following delivery (delivery day, day 0)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
6 Hour Foley	Cesarean Delivery Rate	17 Participants
12 Hour Foley	Cesarean Delivery Rate	25 Participants

p-value: 0.14Chi-squared

Secondary

Delivery Within 12 Hours

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

Time frame: Assessed following delivery (delivery day, day 0)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
6 Hour Foley	Delivery Within 12 Hours	14 Participants
12 Hour Foley	Delivery Within 12 Hours	9 Participants

p-value: 0.39Chi-squared

Secondary

Delivery Within 24 Hours

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

Time frame: Assessed following delivery (delivery day, day 0)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
6 Hour Foley	Delivery Within 24 Hours	60 Participants
12 Hour Foley	Delivery Within 24 Hours	42 Participants

p-value: <0.01Chi-squared

Secondary

Indication for Cesarean Delivery

Number of Patient with Indication for Cesarean Delivery

Time frame: Assessed following delivery (delivery day, day 0)

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
6 Hour Foley	Indication for Cesarean Delivery	10 Participants
12 Hour Foley	Indication for Cesarean Delivery	11 Participants

p-value: 0.8Chi-squared

Secondary

Maternal Complications

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