Status:
TERMINATED
Open Label Comparative Trial of Dinoprostone Plus or Minus Oxytocin Versus Oxytocin Alone in Cervical Ripening for Labor Induction
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Vaginal Delivery
Cesarean Section
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- Singleton pregnancy
- Gestational age ≥ 38 weeks
- Fetal cephalic presentation
- Bishop score \< 6
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT01190163
Start Date
June 1 2010
End Date
January 1 2012
Last Update
August 23 2012
Active Locations (4)
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1
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, Brazil
2
Hospital Municipal Universitário - Faculdade de Medicina do ABC
São Bernardo do Campo, São Paulo, Brazil
3
Hospital M Boi Mirim
São Paulo, São Paulo, Brazil
4
Hospital Maternidade Leonor Mendes de Barros
São Paulo, São Paulo, Brazil