NCT02606643

Brief Summary

Once admitted, women who will have a transcervical balloon catheter inserted for induction will be approached for participation in this study. If they agree to be take part in this study (tape or no tape) they will be randomized into the study. After the balloon catheter is inserted, the balloon will then be filled with approximately 50-60 mL of normal saline, this is normal procedure. Study related: If randomized to "No Taping" the foley will be positioned comfortable and not placed to tension. For the "Tension" arm, tension will be placed on the balloon catheter, which will then be taped to the patient's inner thigh. The tension will be assessed and retaped as needed approximately every 30 minutes by the research and/or the nursing staff.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 17, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
2 years until next milestone

Results Posted

Study results publicly available

November 7, 2018

Completed
Last Updated

November 7, 2018

Status Verified

February 1, 2018

Enrollment Period

1.8 years

First QC Date

August 24, 2015

Results QC Date

July 29, 2016

Last Update Submit

November 6, 2018

Conditions

Cervical Dilation

Outcome Measures

Primary Outcomes (1)

  • Duration

    Hours of labor

    hours to delivery 0-26

Secondary Outcomes (2)

  • Deliveries Via Cesarean Delivery

    intraoperative

  • Vaginal Delivery Within 24 Hours

    24 hours

Study Arms (2)

Group 1 Catheter to slight traction

ACTIVE COMPARATOR

For the "Tension" arm (research related), slight tension will be placed on the catheter, which will then be taped to the patient's inner thigh. The tension will be assessed and retaped as needed every 30 minutes by the research and/or the nursing staff. Only slight tension will be applied to those catheters assign to the tension group. The catheter will be taped to the inner thigh so there is no "sag" in the catheter from the urethra to the tape. There is no method or device to "measure" the tension placed on these catheters, if the patient moves her leg it can lessen or increase the tension, these are known factors.

Procedure: Slight traction

Group 2 Catheter to no traction

ACTIVE COMPARATOR

Foley catheter to no traction placed as SOC "No traction" applied

Procedure: Foley Catheter to no traction

Interventions

Slight tractionPROCEDURE

Slight traction will be applied to the balloon catheter

Group 1 Catheter to slight traction
Foley Catheter to no tractionPROCEDURE

Foley Catheter to no traction

Group 2 Catheter to no traction

Eligibility Criteria

Age14 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • singleton gestation
  • Bishop score less than or equal to 6
  • cephalic presentation

You may not qualify if:

  • prostaglandins given this admission
  • any medical conditions precluding vaginal delivery
  • significant cervical or intrauterine infection
  • significant vaginal bleeding
  • intrauterine fetal demise
  • low lying placenta
  • prior cervical surgery
  • latex allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Mary's Health Center

St Louis, Missouri, 63117, United States

Location

Related Publications (1)

  • de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

    PMID: 36996264DERIVED

Results Point of Contact

Title
Gary Furhman
Organization
Saint Louis University
jathompson@slu.edu
314-977-2090

Study Officials

  • Gary Fruhman, MD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2015

First Posted

November 17, 2015

Study Start

October 1, 2014

Primary Completion

July 1, 2016

Study Completion

November 1, 2016

Last Updated

November 7, 2018

Results First Posted

November 7, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)