Skip to content

Trial · Interventional

CompletedNot applicableResults postedRegistry data

Length of Cook Catheter Placement and Induction of Labor

NCTNCT04233008 (opens ClinicalTrials.gov in a new tab)Other id54321
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Oxytocin, does not test it. It appears in the summary.

Overview

Status
Completed
Phase
Not applicable
Enrollment
178 participants (actual)
Sponsor
Brigham and Women's Hospital · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
1 Jan 2019
Primary completion
1 Jul 2020
Completion
1 Jul 2020
First posted
18 Jan 2020
Last update posted
24 Jun 2022
Conditions
Induction of Labor

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021
  1. N/A

    Length of Cook Catheter Placement and Induction of Labor

    NCT04233008

    1 Jan 2019 to 1 Jul 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Foley catheter lengthDevice

Arms2

  • Experimental

    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.

  • No intervention

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Time to Delivery

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

    Registry description

    Time to delivery

Secondary outcomes(11)

  1. Cesarean Delivery Rate

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

    Registry description

    Cesarean delivery rate

  2. Time to Active Labor

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

    Registry description

    Time to reaching active labor (defined as 5cm)

  3. Delivery Within 12 Hours

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

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    Number of Patient with Indication for Cesarean Delivery

  7. Maternal Complications

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

    Registry description

    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)

    Registry description

    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)

    Registry description

    Number of infants admitted to NICU

  10. NICU Admission >48 Hours

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

    Registry description

    Number of infants admitted to NICU for \>48 hours

  11. Neonatal Length of Stay

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

    Registry description

    Days of hospital stay

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· Assessed following delivery (delivery day, day 0)

Time to Delivery

GroupValue (hours)
6 Hour Foley19.2
12 Hour Foley24.3
Secondary and other outcome results(7)
Secondary outcomeCount of participants· Assessed following delivery (delivery day, day 0)

Cesarean Delivery Rate

GroupValue (Participants)
6 Hour Foley17
12 Hour Foley25
Secondary outcomeMedian· Assessed following delivery (delivery day, day 0)

Time to Active Labor

GroupValue (hours)
6 Hour Foley10.5
12 Hour Foley15.9
Secondary outcomeCount of participants· Assessed following delivery (delivery day, day 0)

Delivery Within 12 Hours

GroupValue (Participants)
6 Hour Foley14
12 Hour Foley9
Secondary outcomeCount of participants· Assessed following delivery (delivery day, day 0)

Delivery Within 24 Hours

GroupValue (Participants)
6 Hour Foley60
12 Hour Foley42
Secondary outcomeMedian· Assessed at end of study period (week 4)

Maternal Length of Stay

GroupValue (days)
6 Hour Foley2
12 Hour Foley2
Secondary outcomeCount of participants· Assessed following delivery (delivery day, day 0)

Indication for Cesarean Delivery

GroupValue (Participants)
6 Hour Foley10
12 Hour Foley11
Secondary outcomeCount of participants· Assessed at end of study period (week 4)

Maternal Complications

GroupValue (Participants)
6 Hour Foley7
12 Hour Foley8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
6 Hour Foley - MothersThe 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 description0 / 890 / 890 / 89
12 Hour Foley - MothersThe 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.0 / 890 / 890 / 89
6 Hour Foley - NeonatesThe 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 description0 / 890 / 890 / 89
12 Hour Foley - NeonatesThe 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.0 / 890 / 890 / 89

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

More studies

3 studies on this page

Indexing hint: Randomized controlled trial · 2021

Six versus twelve hours of single-balloon catheter placement with oxytocin administration for labor induction: a randomized controlled trial.

Lassey et al. 2021American journal of obstetrics and gynecologycited by 22

PMID 33771496DOI 10.1016/j.ajog.2021.03.021PUB-33771496

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2016

Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial.

Levine et al. 2016Obstetrics and gynecologycited by 107

PMID 27824758PMC5127406DOI 10.1097/aog.0000000000001778PUB-27824758

Rights unknown
Source link

Indexing hint: Systematic review · 2001

Mechanical methods for induction of labour.

Boulvain et al. 2001The Cochrane database of systematic reviewscited by 49

PMID 11687101DOI 10.1002/14651858.cd001233PUB-11687101

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.