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

This study has been terminated.
(Study was early terminated due to problems enrolling adequate number of patients)
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01190163
First received: August 26, 2010
Last updated: August 22, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Vaginal Delivery
Cesarean Section
Drug: Dinoprostone
Drug: Oxytocin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Vaginal birth delivery within 24 hours and C-section rate [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment failure rate [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Uterine hyperstimulation and/or fetal distress [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Use of additional oxytocin [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 170
Study Start Date: June 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Dinoprostone
Active Comparator: B Drug: Oxytocin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190163

Locations
Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, Brazil
Hospital Municipal Universitário - Faculdade de Medicina do ABC
São Bernardo, São Paulo, Brazil
Hospital M Boi Mirim
São Paulo, Brazil
Hospital Maternidade Leonor Mendes de Barros
São Paulo, Brazil
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01190163     History of Changes
Other Study ID Numbers: FE999901 CS01
Study First Received: August 26, 2010
Last Updated: August 22, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Ferring Pharmaceuticals:
Vaginal Birth delivery within 24 hours and C-section rate

Additional relevant MeSH terms:
Dinoprostone
Oxytocin
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014