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

Cesarean Section Clinical Trial

— SOFTNES  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01190163
• Other study ID #: FE999901 CS01
• Status: Terminated
• Phase: Phase 4
• First received: August 26, 2010
• Last updated: August 22, 2012
• Start date: June 2010
• Est. completion date: January 2012

Study information

• Verified date: August 2012
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 170
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cesarean Section
• Vaginal Delivery

Intervention

Drug:
• Dinoprostone

• Oxytocin

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal birth delivery within 24 hours and C-section rate		24 hours	No
Secondary	Treatment failure rate		24 hours	No
Secondary	Uterine hyperstimulation and/or fetal distress		24 hours	Yes
Secondary	Use of additional oxytocin		24 hours	No