NCT03086967

Brief Summary

The Foley catheter is a safe, effective method for cervical ripening. Limited data exists to indicate ideal time of placement for optimal cervical ripening prior to induction. The proposed study is a randomized control trial to determine if shortening placement from 12 to 6 hours of foley catheter can decrease time from start of induction to delivery. The prediction is that shortening foley bulb placement will result in shorter induction times, increased patient satisfaction and decreased length of stay on labor and delivery with secondary decreased medical costs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 22, 2017

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

November 30, 2022

Completed
Last Updated

November 30, 2022

Status Verified

March 1, 2017

Enrollment Period

2.3 years

First QC Date

February 21, 2017

Results QC Date

September 9, 2022

Last Update Submit

November 9, 2022

Conditions

Induction of Labor Affected Fetus / Newborn

Keywords

cervical ripeningdouble lumen catheter

Outcome Measures

Primary Outcomes (3)

  • Time From Foley Bulb Placement to Time of Delivery.

    Time in hours to delivery following use of foley catheter

    Change in time to delivery following bulb insertion for 6 hours up to 72 hours

  • Time to Delivery of Trial of Labor After Cesarean Section

    Time (hours) to delivery

  • 1 Minute Apgar Score of Trial of Labor After Cesarean Section

    The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.

    1 minute Apgar score following birth

Secondary Outcomes (8)

  • Time From Foley Bulb Placement to Extrusion

    Hour 6, Hour 12

  • Mode of Delivery--Number of Participants Having Cesarean Delivery

    Hour Six, Hour 12

  • Bacterial Infection (Chorioamnionitis)

    Hour Six, Hour 12

  • Endometritis

    Hour 6, Hour 12

  • 1 Minute Apgar Score

    1 minute Apgar score following birth

  • +3 more secondary outcomes

Study Arms (2)

Six Hour

ACTIVE COMPARATOR

Placement of foley catheter and extrusion after 6 hours followed by induction.

Device: Double-lumen balloon catheter

Twelve Hour

ACTIVE COMPARATOR

Placement of foley catheter and extrusion after 12 hours followed by induction.

Device: Double-lumen balloon catheter

Interventions

Double-lumen balloon catheterDEVICE

introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices

Also known as: foley bulb
Six HourTwelve Hour

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Intrauterine pregnancy at 37 weeks gestational age or greater as determined by best obstetrical dating criteria
  • Singleton gestation
  • Vertex presentation
  • Clinically adequate pelvis
  • Bishop Score less than or equal to 6
  • years and older
  • North Carolina state law provides for the emancipation of minors, Chapter 7B-Article 35.

You may not qualify if:

  • Any maternal or fetal contraindication to vaginal delivery
  • Known uterine anomaly
  • Multifetal gestation
  • Estimated fetal weight of 4500 gm or greater
  • Ruptured membranes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carolinas Medical Center

Charlotte, North Carolina, 28232, United States

Location

Results Point of Contact

Title
Dr. Susan Bliss
Organization
Atrium Health
Susan.Bliss@atriumhealth.org
(704)562-4860

Study Officials

  • Susan A Bliss, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2017

First Posted

March 22, 2017

Study Start

June 1, 2013

Primary Completion

September 1, 2015

Study Completion

February 1, 2016

Last Updated

November 30, 2022

Results First Posted

November 30, 2022

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)