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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01190163
Recruitment Status : Terminated (Study was early terminated due to problems enrolling adequate number of patients)
First Posted : August 27, 2010
Last Update Posted : August 23, 2012
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Vaginal Delivery Cesarean Section Drug: Dinoprostone Drug: Oxytocin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2010
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A Drug: Dinoprostone
Active Comparator: B Drug: Oxytocin

Primary Outcome Measures :
  1. Vaginal birth delivery within 24 hours and C-section rate [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Treatment failure rate [ Time Frame: 24 hours ]
  2. Uterine hyperstimulation and/or fetal distress [ Time Frame: 24 hours ]
  3. Use of additional oxytocin [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01190163

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
Study Director: Clinical Development Support Ferring Pharmaceuticals

Responsible Party: Ferring Pharmaceuticals Identifier: NCT01190163     History of Changes
Other Study ID Numbers: FE999901 CS01
First Posted: August 27, 2010    Key Record Dates
Last Update Posted: August 23, 2012
Last Verified: August 2012

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

Additional relevant MeSH terms:
Reproductive Control Agents
Physiological Effects of Drugs