comparison of two different methods (Foley cetheter or oral misoprostol) for labour inductio

Conditions: Induction of labour at term
MedDRA version: 16.0Level: LLTClassification code 10023540Term: Labor inducedSystem Organ Class: 100000004868
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2011-000026-30-NL

Lead Sponsor: Academic medical centre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 1860

Inclusion Criteria

Term pregnancy (=37 weeks of pregnancy)
Scheduled for induction of labour
Vital singleton pregnancy
Intact membranes
Unfavourable cervix (Bishop score < 6)
Cephalic presentation
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 1860
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Previous caesarean section
Placenta praevia
Hypersensitivity for one of the products used for induction
Age <18 years
Lethal congenital anomalies

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess in term pregnant women with an unfavourable cervix (Bischop score <6) the effectiveness of induction of labor with a transcervical Foley catheter or oral misoprostol;Secondary Objective: To study the safety, costs and patients preferences for both methods;Primary end point(s): The main endpoint will be a composite outcome of neonatal asphyxia (defined as a neonatal<br>pH=7.10 and/or 5 minute Apgar<7) and post partum haemorrhage (defined as an estimated<br>blood loss of =1000 cc ascertained over 24h post partum);Timepoint(s) of evaluation of this end point: After inclusions, estimated time will be july 2014

Secondary Outcome Measures