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Induction of Labor in Women With Unfavorable Cervix: Dilapan Versus Foley Bulb

NCT02899689 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 419

Last updated 2020-11-18

Study results available
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Summary

Women undergoing mechanical cervical ripening for labor induction will be randomized to Dilapan-S® versus Foley bulb. The investigators hypothesized that osmotic cervical dilators (Dilapan-S®) are as effective as Foley bulb catheter in rates of vaginal delivery.

Conditions

  • Pre-induction Dilation of Cervix

Interventions

DEVICE

Dilapan

Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os.

DEVICE

Foley Catheter

Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl.

Sponsors & Collaborators

  • Medicem International CR s.r.o.

    collaborator INDUSTRY

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Antonio Saad, MD · Assistant Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-02-28
Completion
2018-02-28
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 NCT02899689 on ClinicalTrials.gov