NCT02210598

Brief Summary

This study represents the first randomized trial comparing traditional inpatient induction with a transcervical foley catheter versus outpatient induction with immediate removal of a transcervical foley catheter. The immediate removal technique allows the induction process to begin in the hospital setting, but allows the patient to go home without a foreign body in situ. The investigators hypothesize the outpatient group will spend less time hospitalized prior to discharge. Additionally, the investigators will explore the vaginal delivery rates and maternal/neonatal safety profiles between groups.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 6, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

3.8 years

First QC Date

March 19, 2014

Last Update Submit

April 17, 2017

Conditions

PregnancyLabor; Forced or Induced, Affecting Fetus or Newborn

Keywords

labor, inducedcatheteroxytocinCesarean section

Outcome Measures

Primary Outcomes (1)

  • Duration of inpatient hospitalization (hours)

    compare inpatient time as measured by time from admission to time to discharge between the control (standard transcervical foley balloon placement/inpatient procedure) and the experimental group (immediate removal transcervical foley balloon placement/outpatient procedure)

    time from hospital admission to time to discharge, on average 96 hours

Secondary Outcomes (8)

  • Duration of labor induction (hours)

    time of initiation of labor induction to delivery, on average 24 hours

  • Cesarean section rate (percentage)

    determined at time of delivery

  • Duration of oxytocin use during labor induction (hours)

    time of initiation of oxytocin until it is discontinued, on average 18 hours

  • Rate of patients having prolonged fetal heart rate decelerations during labor induction (percentage)

    from initiation of labor induction to delivery, on average 24 hours

  • Rate of patients developing chorioamnionitis during labor induction (percentage)

    from initiation of induction until delivery, on average 24 hours

  • +3 more secondary outcomes

Study Arms (2)

inpatient Foley balloon induction

ACTIVE COMPARATOR

Inpatient Foley induction participants will be placed in the dorsal lithotomy position, a Foley catheter will be placed transcervically and its balloon filled with 60mL of sterile saline. One of two methods will be used to place the transcervical foley based on provider preference and determination of which method will offer the greatest chance for successful placement. Method A is placement of the foley "blindly" by palpation of the cervix. Method B utilizes direct visualization with sterile speculum placement. Method will be documented in the data collection forms. The catheter will be left in place and IV oxytocin will be started per LAC+USC protocol. The foley catheter will be removed after 12 hours if not spontaneously extruded.

Device: inpatient Foley balloon inductionDrug: Oxytocin

outpatient Foley balloon induction

EXPERIMENTAL

Patients randomized to the experimental group will undergo outpatient Foley induction of labor. Either of the above two described methods will be used to place an 18 French Foley catheter transcervically and its balloon filled with 60mL of sterile saline. The catheter will be deflated and removed within 10 minutes of placement. The patient will then undergo a non-stress test (NST). If the patient has a reactive NST with no late or variable decelerations or uterine tachysystole, the patient will be discharged home with clear return precautions and instructions to return to the triage area in 24 hours. When the patient returns to the hospital, a sterile vaginal exam will be done and Bishop score documented. The patient will then be admitted to L\&D for inpatient continuation of induction with IV oxytocin per LAC+USC protocol.

Device: outpatient Foley balloon inductionDrug: Oxytocin

Interventions

inpatient Foley balloon inductionDEVICE

The catheter will be left in place and IV oxytocin will be started per LAC+USC protocol. The foley catheter will be removed after 12 hours if not spontaneously extruded.

Also known as: 18-French Bard catheter
inpatient Foley balloon induction
outpatient Foley balloon inductionDEVICE

The catheter will be deflated and removed within 10 minutes of placement. The patient will then undergo a non-stress test (NST). If the patient has a reactive NST with no late or variable decelerations or uterine tachysystole, the patient will be discharged home with clear return precautions and instructions to return to the triage area in 24 hours.

Also known as: 18-French Bard catheter
outpatient Foley balloon induction
OxytocinDRUG

When a patient randomized to the outpatient Foley Balloon induction group returns to the hospital, a sterile vaginal exam will be done and Bishop score documented. The patient will then be admitted to L\&D for inpatient continuation of induction with IV oxytocin per LAC+USC protocol. Patients randomized to the inpatient Foley balloon induction group will have IV oxytocin initiated per LAC+USC protocol at the time of Foley balloon placement.

inpatient Foley balloon inductionoutpatient Foley balloon induction

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Viable Intrauterine Pregnancy
  • Greater than or equal to 37 weeks gestation on date of induction
  • Cephalic Presentation
  • Medically indicated induction of labor
  • AFI greater than or equal to 5
  • Patient able to be contacted by phone and demonstrates an understanding of the return instructions
  • Cervical Dilation 2cm or less

You may not qualify if:

  • Placenta Previa/Low Lying Placenta
  • Placenta accreta/increta/percreta
  • Undiagnosed vaginal bleeding
  • Preeclampsia or HELLP Syndrome
  • Intrauterine Growth Restriction
  • Rupture of Membranes
  • Prior cesarean section or transfundal uterine surgery
  • Twin Gestation
  • Fetal Anomaly
  • Rh Isoimmunization
  • Fetal Demise
  • Uterine Tachysystole
  • Less than 18 years of age
  • HIV Infection
  • Active herpes, hepatitis B or C infection
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Los Angeles County + University of Southern California Medical Center

Los Angeles, California, 90033, United States

RECRUITING

Related Publications (5)

  • Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. doi: 10.1016/s0029-7844(01)01579-4.

    PMID: 11704164RESULT

  • Kelly AJ, Alfirevic Z, Dowswell T. Outpatient versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007372. doi: 10.1002/14651858.CD007372.pub2.

    PMID: 19370687RESULT

  • Henry A, Madan A, Reid R, Tracy SK, Austin K, Welsh A, Challis D. Outpatient Foley catheter versus inpatient prostaglandin E2 gel for induction of labour: a randomised trial. BMC Pregnancy Childbirth. 2013 Jan 29;13:25. doi: 10.1186/1471-2393-13-25.

    PMID: 23356673RESULT

  • 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

  • Alfirevic Z, Gyte GM, Nogueira Pileggi V, Plachcinski R, Osoti AO, Finucane EM. Home versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007372. doi: 10.1002/14651858.CD007372.pub4.

    PMID: 32852803DERIVED

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Patrick M Mullin, MD

    University of Southern California

    STUDY DIRECTOR

  • Yen Chan, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR

  • Richard Lee, MD

    University of Southern California

    STUDY DIRECTOR

Central Study Contacts

Patrick M Mullin, MD

CONTACT

pmullin@usc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 19, 2014

First Posted

August 6, 2014

Study Start

March 1, 2014

Primary Completion

January 1, 2018

Last Updated

April 19, 2017

Record last verified: 2017-04

Locations

US(1)