Open Label Comparative Trial of Dinoprostone Plus or Minus Oxytocin Versus Oxytocin Alone in Cervical Ripening for Labor Induction (SOFTNES)
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ClinicalTrials.gov Identifier: NCT01190163
(Study was early terminated due to problems enrolling adequate number of patients)
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
Primary Completion Date
Study Completion Date
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Gestational age ≥ 38 weeks
Fetal cephalic presentation
Bishop score < 6
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