safety of partial outpatient induction of labour with a balloon catheter

Safety and cost-effectiveness of induction of labour with a Foley catheter in an outpatient setting

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON27343

Enrollment

1500

Registered

2017-09-08

Start date

2017-08-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

None listed

Interventions

partial outpatient induction of labour with a foley catheter according to local protocol. observational study of routine care.

Eligibility

Inclusion criteria

Inclusion criteria: • Term pregnancy (≥37 weeks gestation) • Indication for induction of labour • Vital singleton pregnancy • Cephalic presentation • Planned for outdoor induction of labour • Unfavourable cervix (Bishop score <6) • Intact membranes

Exclusion criteria

Exclusion criteria: • Lethal congenital anomaly • Placenta praevia (marginalis) (placenta ≤2cm from ostium) • Non-reassuring fetal heart rate prior to induction • Indication for clinical surveillance (extreme FGR, pre eclampsia/HELLP, uncontrolled (gestational) diabetes mellitus)

Design outcomes

Primary

Measure	Time frame
- (Severe) adverse events during outpatient period - Adverse neonatal outcome - Causal relation between (severe) adverse event/neonatal outcome and outpatient period judged by an expert panel	—

Secondary

Measure	Time frame
- maternal and perinatal morbidity - efficacy - cost-effectiveness	—

Contacts

Public ContactMarieke de Vaan

ma.d.vaan@jbz.nl073-5532020

Outcome results