MedTrace Logo

Cook Balloon vs Dilapan-S for Outpatient Cervical Ripening

NCT05062343 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-10-27

Study results available
· View outcomes & findings →

Summary

The goal of this study is to compare Cook balloon and Dilapan-S for outpatient cervical ripening to see if Dilapan-S is non-inferior in increasing Bishop score compared to the Cook balloon.

Conditions

  • Induced; Birth

Interventions

DEVICE

Dilapan-S

Osmotic dilator

DEVICE

Cook Cervical Ripening Balloon

Double balloon catheter for cervical ripening

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2023-07-19
Completion
2023-07-19
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT05062343 on ClinicalTrials.gov