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Outpatient Labor Induction With the Transcervical Foley Balloon

NCT02210598 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2017-04-19

No results posted yet for this study

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.

Conditions

  • Pregnancy
  • Labor; Forced or Induced, Affecting Fetus or Newborn

Interventions

DEVICE

inpatient Foley balloon induction

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

outpatient Foley balloon induction

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.

DRUG

Oxytocin

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.

Sponsors & Collaborators

  • University of Southern California

    lead OTHER

Principal Investigators

  • Patrick M Mullin, MD · University of Southern California

  • Yen Chan, MD · University of Southern California

  • Richard Lee, MD · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2018-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02210598 on ClinicalTrials.gov