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Inpatient Versus Outpatient Cervical Ripening

NCT03769610 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-04-14

No results posted yet for this study

Summary

Induction of labor is a process of stimulating uterine contractions before the onset of labor, with a goal of achieving vaginal birth. The cervix (the lower part of the uterus that connects to the vagina) must dilate (open) in order to allow passage of the baby into the vagina and through the birth canal. A process called "cervical ripening" is often performed prior to labor induction to prepare the cervix for labor and therefore shorten the length of the labor. There are various pharmacologic and mechanical methods of cervical ripening that result in the physical softening and distensibility of the cervix. Mechanical dilation with a small balloon (i.e. a Foley catheter) placed in the cervix is one of the most commonly used, safe, inexpensive, and effective methods to achieve cervical ripening.

In most hospitals, cervical ripening is performed in the hospitals; however, some hospitals allow women to undergo cervical ripening at home with a transcervical Foley catheter. The goal of this study is to compare the use of a Foley catheter for cervical ripening in the inpatient (in-hospital) and outpatient (at home) settings. We anticipate that outpatient use will lead to a shorter amount of time that a woman spends in the hospital, decreased cost, and good patient satisfaction.

Conditions

  • Pregnancy Related
  • Labor
  • Induction
  • Cervical Ripening

Interventions

OTHER

Inpatient Foley catheter

OTHER

Outpatient Foley catheter

Sponsors & Collaborators

  • Thomas Jefferson University

    collaborator OTHER

  • LifeBridge Health

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-04
Primary Completion
2021-04-01
Completion
2021-04-01

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 NCT03769610 on ClinicalTrials.gov