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Induction of LaborNCT04233008

Length of Cook Catheter Placement and Induction of Labor

A study testing Foley catheter length in people with Induction of Labor, run by Brigham and Women's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Induction of Labor
What is being tested?
Foley catheter length
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
178 participants
Where
1 siteUnited States
Study dates
1 Jan 2019to 1 Jul 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

None listed.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02116

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Foley catheter length
Keywords
Maternal outcomes, Neonatal Outcomes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Foley catheter lengthDevice

    see arm description

Study groups in NCT04233008
Study groupRoleWhat they receive
6 hour foleyExperimentalThe 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.
Receives: Device: Foley catheter length
12 hour foleyNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Delivery

    Time to delivery

    Measured: Assessed following delivery (delivery day, day 0)

Secondary outcomes (11)

  1. Cesarean Delivery Rate

    Cesarean delivery rate

    Measured: Assessed following delivery (delivery day, day 0)

  2. Time to Active Labor

    Time to reaching active labor (defined as 5cm)

    Measured: Assessed following delivery (delivery day, day 0)

  3. Delivery Within 12 Hours

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

    Measured: Assessed following delivery (delivery day, day 0)

  4. Delivery Within 24 Hours

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

    Measured: Assessed following delivery (delivery day, day 0)

  5. Maternal Length of Stay

    Length of hospital stay from start of induction to postpartum discharge

    Measured: Assessed at end of study period (week 4)

  6. Indication for Cesarean Delivery

    Number of Patient with Indication for Cesarean Delivery

    Measured: Assessed following delivery (delivery day, day 0)

  7. Maternal Complications

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

    Measured: Assessed at end of study period (week 4)

  8. Neonatal Complications

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

    Measured: Assessed at end of study period (week 4)

  9. NICU Admission

    Number of infants admitted to NICU

    Measured: Assessed at end of study period (week 4)

  10. NICU Admission >48 Hours

    Number of infants admitted to NICU for >48 hours

    Measured: Assessed at end of study period (week 4)

  11. Neonatal Length of Stay

    Days of hospital stay

    Measured: Assessed at end of study period (week 4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2020
  2. Study start1 Jan 2019
  3. Primary completion1 Jul 2020
  4. Study completion1 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial
Masking
None (open label)
Enrolment
178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04233008
Sponsor's protocol ID
54321
Status last verified
May 2022
First submitted
13 Jan 2020
Last updated
24 Jun 2022
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Research only shared within study staff

Publications

  • Battarbee AN, Palatnik A, Peress DA, Grobman WA. Association of Early Amniotomy After Foley Balloon Catheter Ripening and Duration of Nulliparous Labor Induction. Obstet Gynecol. 2016 Sep;128(3):592-597. doi: 10.1097/AOG.0000000000001563.

    PubMed 27500341

  • Boulvain M, Kelly A, Lohse C, Stan C, Irion O. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2001;(4):CD001233. doi: 10.1002/14651858.CD001233.

    PubMed 11687101

  • Cromi A, Ghezzi F, Agosti M, Serati M, Uccella S, Arlant V, Bolis P. Is transcervical Foley catheter actually slower than prostaglandins in ripening the cervix? A randomized study. Am J Obstet Gynecol. 2011 Apr;204(4):338.e1-7. doi: 10.1016/j.ajog.2010.11.029. Epub 2011 Jan 26.

    PubMed 21272849

  • Hamilton BE, Martin JA, Osterman MJ, Curtin SC, Matthews TJ. Births: Final Data for 2014. Natl Vital Stat Rep. 2015 Dec;64(12):1-64.

    PubMed 26727629

  • Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1357-1364. doi: 10.1097/AOG.0000000000001778.

    PubMed 27824758

  • Lassey SC, Haber HR, Kanbergs A, Robinson JN, Little SE. Six versus twelve hours of single-balloon catheter placement with oxytocin administration for labor induction: a randomized controlled trial. Am J Obstet Gynecol. 2021 Jun;224(6):611.e1-611.e8. doi: 10.1016/j.ajog.2021.03.021. Epub 2021 Mar 23.

    PubMed 33771496

Questions about this trial

What is this clinical trial studying?

A study testing Foley catheter length in people with Induction of Labor, run by Brigham and Women's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Delivery (time frame: Assessed following delivery (delivery day, day 0)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04233008, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.

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