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

Phase 4TerminatedNCT01190163

Ferring Pharmaceuticals170 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

170

Conditions

Vaginal Delivery Cesarean Section

Interventions

DinoprostoneDRUG

OxytocinDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (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

Outcomes

Primary Outcomes

Vaginal birth delivery within 24 hours and C-section rate

Time frame: 24 hours

Secondary Outcomes

Treatment failure rate

Time frame: 24 hours

Uterine hyperstimulation and/or fetal distress

Time frame: 24 hours

Use of additional oxytocin

Time frame: 24 hours

Data from ClinicalTrials.gov

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