Foley catheter for Induction of Labour filled with 30ml or 60ml

Foley catheter for Induction of Labour filled with 30ml or 60ml - The FILL study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39008

Enrollment

174

Registered

2013-11-26

Start date

2014-01-27

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

Induction of labour

Interventions

Transcervical Foley catheter filled with 30mL or a transcervical Foley catheter filled with 60mL.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Term pregnancy (*37 weeks of pregnancy) Scheduled for induction of labour Vital singleton pregnancy Intact membranes Unfavourable cervix (Bishop score

Exclusion criteria

Exclusion criteria: Maternal age

Design outcomes

Primary

Measure	Time frame
The main study parameter will be the time interval between start of induction and delivery.	—

Secondary

Measure	Time frame
Costs of induction - Resource use will be derived from the Case Report Form. - Different methods and sources will be used to estimate unit costs as valuations for documented volumes of resource use. For maternal and neonatal admissions, delivery and neonatal monitoring, unit costs will be estimated with data from the financial department of Bronovo hospital. For use of the labour room and the operating theatre, unit costs are calculated per hour, using a bottom-up approach. For some cost units, national standardised prices will be used, and for laboratory testing, published tariffs will be used. Medication prices will be derived from the Pharmacotherapeutic Compass. Induction to delivery time (deliveries within 12 hours, and 24 hours, of Foley catheter placement) Induction to catheter expulsion time Bishop score after catheter expulsion Mode of delivery Umbilical cord prolapse Maternal morbidity - Hyperstimulation (defined as more than six contractions in ten minutes over a minimal period of two times ten minutes, or a contraction lasting more than three minutes) - Uterine rupture - Placental abruption - Maternal infection - Fever (defined as an aural temperature * 38°C) during labour or within one week post partum - Foetal tachycardia - Start of intravenous antibiotics - Endometritis within one week post partum - Vaginal swab culture Post partum haemorrhage (defined as an estimated blood loss of >1000 cc) Neonatal morbidity - Apgar scores	—

Measure

Time frame

Costs of induction - Resource use will be derived from the Case Report Form. - Different methods and sources will be used to estimate unit costs as valuations for documented volumes of resource use. For maternal and neonatal admissions, delivery and neonatal monitoring, unit costs will be estimated with data from the financial department of Bronovo hospital. For use of the labour room and the operating theatre, unit costs are calculated per hour, using a bottom-up approach. For some cost units, national standardised prices will be used, and for laboratory testing, published tariffs will be used. Medication prices will be derived from the Pharmacotherapeutic Compass. Induction to delivery time (deliveries within 12 hours, and 24 hours, of Foley catheter placement) Induction to catheter expulsion time Bishop score after catheter expulsion Mode of delivery Umbilical cord prolapse Maternal morbidity - Hyperstimulation (defined as more than six contractions in ten minutes over a minimal period of two times ten minutes, or a contraction lasting more than three minutes) - Uterine rupture - Placental abruption - Maternal infection - Fever (defined as an aural temperature * 38°C) during labour or within one week post partum - Foetal tachycardia - Start of intravenous antibiotics - Endometritis within one week post partum - Vaginal swab culture Post partum haemorrhage (defined as an estimated blood loss of >1000 cc) Neonatal morbidity - Apgar scores

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)