Induction of labour in hospital with a Foley catheter or oral misoprostol versus induction of labour at home with a Foley catheter or oral misoprostol

Phase 3

Withdrawn

Conditions: Induction of labour
10010273

Registration Number: NL-OMON48395

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 2828

Inclusion Criteria

Vital singleton pregnancy in cephalic presentation
Intact membranes
Gestational age of 37 weeks or more
Unfavourable cervix (Bishop score <6)
Indication for induction of labour

Exclusion Criteria

History of a Caesarean section or other uterine surgery with risk of uterine
rupture
Non-reassuring cardiotocography
Suspected severe fetal growth restriction defined as EFW Doppler's
Placenta praevia or vasa praevia
Women with an indication for clinical observation (such as pre-eclampsia)
Non-engaged fetal head
Allergy for misoprostol
Aged younger than 18 year
Fetal lethal or major congenital anomaly
Fetal chromosomal abnormality (e.g. trisomy 21)
Severe kidney failure defined as an eGFR <15 ml/min/1.73m2
Liver failure
Inability to reach hospital within 30 minutes by own transport
Insufficient ability to communicate in Dutch or English by phone
Not willing or able to provide written informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint regarding safety will be a composite outcome of neonatal<br /><br>asphyxia (defined as a neonatal pH*7.05 and/or 5 minute Apgar<7), mortality<br /><br>(intrapartum/neonatal/perinatal) or NICU admission.<br /><br>The main endpoint for effectiveness will be the percentage of vaginal<br /><br>deliveries. </p><br>

Secondary Outcome Measures