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Completed

NCT Number: NCT04233008

Length of Cook Catheter Placement and Induction of Labor

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02116, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Foley catheter length

Device

see arm description

Primary outcomes

  1. Time to Delivery

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

    Time to delivery

Secondary outcomes

  1. Cesarean Delivery Rate

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

    Cesarean delivery rate

  2. Time to Active Labor

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

    Time to reaching active labor (defined as 5cm)

  3. Delivery Within 12 Hours

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

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

  4. Delivery Within 24 Hours

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

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

  5. Maternal Length of Stay

    Time frame: Assessed at end of study period (week 4)

    Length of hospital stay from start of induction to postpartum discharge

  6. Indication for Cesarean Delivery

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

    Number of Patient with Indication for Cesarean Delivery

  7. Maternal Complications

    Time frame: 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

  8. Neonatal Complications

    Time frame: 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

  9. NICU Admission

    Time frame: Assessed at end of study period (week 4)

    Number of infants admitted to NICU

  10. NICU Admission >48 Hours

    Time frame: Assessed at end of study period (week 4)

    Number of infants admitted to NICU for >48 hours

  11. Neonatal Length of Stay

    Time frame: Assessed at end of study period (week 4)

    Days of hospital stay

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 18, 2020
Registry last updated
Jun 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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