Efficacy and safety of hourly titrated misoprostol versus vaginal dinoprostone and misoprostol for and labor induction: randomized clinical trial.

Phase 1

Active, not recruiting

• Conditions: labor induction; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2015-003412-20-ES
• Lead Sponsor: Basque Health System

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-13
• Last Update Posted: 29 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

? Women over 18
? single pregnancy
? cephalic presentation
? intact membranes
? unfavorable cervix ( less than 6 Bishop )
? CTGR not reactive decelerative
? Signed informed consent by the patient.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 372
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

? prior Cesarean section or previous uterine surgery .
? Allergy or intolerance to any of the study drugs
? stillbirth
? uterine growth restricted fetuses
? contraindication for vaginal delivery
? Anterior placenta
? Multiparity
? moderate to severe heart disease
? hypertensive disorders of pregnancy
? Suspected chorioamnionitis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified