Study Stopped
Study was early terminated due to problems enrolling adequate number of patients
Open Label Comparative Trial of Dinoprostone Plus or Minus Oxytocin Versus Oxytocin Alone in Cervical Ripening for Labor Induction
SOFTNES
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
1 other identifier
interventional
170
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2010
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 26, 2010
CompletedFirst Posted
Study publicly available on registry
August 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedAugust 23, 2012
August 1, 2012
1.6 years
August 26, 2010
August 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Vaginal birth delivery within 24 hours and C-section rate
24 hours
Secondary Outcomes (3)
Treatment failure rate
24 hours
Uterine hyperstimulation and/or fetal distress
24 hours
Use of additional oxytocin
24 hours
Study Arms (2)
A
EXPERIMENTALB
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Singleton pregnancy
- Gestational age ≥ 38 weeks
- Fetal cephalic presentation
- Bishop score \< 6
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
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 do Campo, São Paulo, Brazil
Hospital M Boi Mirim
São Paulo, São Paulo, Brazil
Hospital Maternidade Leonor Mendes de Barros
São Paulo, São Paulo, Brazil
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2010
First Posted
August 27, 2010
Study Start
June 1, 2010
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
August 23, 2012
Record last verified: 2012-08