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

Ferring

Status and phase: Terminated; Phase 4

Conditions: Cesarean Section; Vaginal Delivery

Treatments: Drug: Dinoprostone; Drug: Oxytocin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01190163

FE999901 CS01

Details and patient eligibility

About

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.

Enrollment: 170 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: Dinoprostone

B

Active Comparator group

Treatment:

Drug: Oxytocin