Comparison of Prostaglandin and Balloon catheter for induction of labour at term.

Evaluation of chemical (Prostaglandins) versus mechanical (transcervical balloon) methods for induction of labour at term.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29022

Enrollment

812

Registered

2009-01-30

Start date

2009-02-02

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

induction of labour at term with an unfavourable cervix

Interventions

Induction of labour with a transcervical Foley catheter compared to intravaginal prostaglandins.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Term pregnancy (>=37 weeks of pregnancy); 2. Scheduled for induction of labour; 3. Vital singleton pregnancy; 4. Intact membranes; 5. Unfavourable cervix (Bishop score < 6); 6. Cephalic presentation.

Exclusion criteria

Exclusion criteria: 1. Previous caesarean section; 2. Placenta praevia; 3. Hypersensitivity for one of the products used for induction; 4. Maternal age <18 years; 5. Severe/lethal congenital anomaly.

Design outcomes

Primary

Measure	Time frame
Caesarean section rate.	—

Secondary

Measure	Time frame
Maternal and neonatal morbidity (e.g. infection rate), to study the cost of both methods.	—

Contacts

Public ContactM. Jozwiak

Trialbureau obs/gyn consortium AMC kamer H4-256 Postbus 22660

probaat@studies-obsgyn.nl+31 (0)20-566 38 57

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)