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Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix

NCT03752073 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2023-04-25

No results posted yet for this study

Summary

This is a randomized prospective trial of two mechanical methods of pre-induction cervical ripening agents.

Conditions

  • Induction of Labor

Interventions

DEVICE

Trans-cervical cervical balloon

Insertion of Foley Catheter

DEVICE

Hygroscopic cervical dilator

Insertion of Dilapan-s

Sponsors & Collaborators

  • Northwell Health

    collaborator OTHER

  • Ochsner Health System

    lead OTHER

Principal Investigators

  • Brigid McCue, MD · Northwell Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2023-01-01
Completion
2023-01-01
FDA Device
Yes

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 NCT03752073 on ClinicalTrials.gov