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Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening.

NCT01170819 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2011-12-13

No results posted yet for this study

Summary

To compare the efficacy of transcervical double balloon catheters versus controlled release dinoprostone vaginal inserts for pre-induction cervical ripening in term women with unfavourable cervices.

Conditions

  • Cervical Ripening
  • Labor Induction

Interventions

DEVICE

Double balloon catheter

The balloons either side of the cervix are inflated with 50 ml of water. The catheter is removed after 12 hours if spontaneous expulsion has not occurred.

DRUG

Dinoprostone 10 mg controlled-release vaginal insert

Vaginal insert is placed in the posterior vaginal fornix for a maximum period of 24 hours.

Sponsors & Collaborators

  • Università degli Studi dell'Insubria

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2011-09-30
Completion
2011-12-31

Countries

  • Italy

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 NCT01170819 on ClinicalTrials.gov