Open Label Comparative Trial of Dinoprostone Plus or Minus Oxytocin Versus Oxytocin Alone in Cervical Ripening for Labor Induction (SOFTNES)

August 22, 2012 updated by: Ferring Pharmaceuticals

Phase IV, Multicenter, Open Label, Randomized Trial to Compare the Effectiveness and Safety of the Dinoprostone Vaginal Pessary vs. Oxytocin for Women Requiring Cervical Ripening Prior to Induction of Labor

This is a comparative trial between oxytocin alone and dinoprostone for cervical ripening in unfavorable cervix pregnant women with 38 or more weeks of gestational age.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil
        • Hospital M Boi Mirim
      • São Paulo, Brazil
        • Hospital Maternidade Leonor Mendes de Barros
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil
        • Hospital Das Clinicas Da Faculdade De Medicina De Ribeirao Preto da Universidade de Sao Paulo
      • São Bernardo, São Paulo, Brazil
        • Hospital Municipal Universitário - Faculdade de Medicina do ABC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Singleton pregnancy
  • Gestational age ≥ 38 weeks
  • Fetal cephalic presentation
  • Bishop score < 6

Exclusion Criteria:

  • No uterine scar (no previous delivery by caesarean section)
  • No more than 3 previous vaginal births
  • No condition that disallows use of prostaglandins for induction of labor
  • Premature rupture of the membranes
  • Oligohydramnios

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B
Drug: Oxytocin
Experimental: A
Drug: Dinoprostone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vaginal birth delivery within 24 hours and C-section rate
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Treatment failure rate
Time Frame: 24 hours
24 hours
Uterine hyperstimulation and/or fetal distress
Time Frame: 24 hours
24 hours
Use of additional oxytocin
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

August 26, 2010

First Submitted That Met QC Criteria

August 26, 2010

First Posted (Estimate)

August 27, 2010

Study Record Updates

Last Update Posted (Estimate)

August 23, 2012

Last Update Submitted That Met QC Criteria

August 22, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FE999901 CS01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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