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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01190163

Acronym

SOFTNES

Enrollment

170

Registered

2010-08-27

Start date

2010-06-30

Completion date

2012-01-31

Last updated

2012-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section, Vaginal Delivery

Keywords

Vaginal Birth delivery within 24 hours and C-section rate

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.

Interventions

DRUGDinoprostone

DRUGOxytocin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Vaginal birth delivery within 24 hours and C-section rate	24 hours

Secondary

Measure	Time frame
Treatment failure rate	24 hours
Uterine hyperstimulation and/or fetal distress	24 hours
Use of additional oxytocin	24 hours

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026