No registrations found.
ID
Source
Brief title
Health condition
- Inleiding van de baring
- Foley katheter
- Induction of labour
- Foley catheter
Sponsors and support
Bronovolaan 5, 2597 AX Den Haag
tel: 070 312 4141
e-mail: WvWijngaarden@bronovo.nl
Intervention
Outcome measures
Primary outcome
The main study parameter is delivery versus no delivery within 8 hours after the membranes are artificially ruptured.
Secondary outcome
• Induction (placement of the Foley catheter) to delivery time
• Number of deliveries within 24 hours after Foley catheter placement
• Induction (placement of the Foley catheter) to catheter expulsion time
• Amniotomy to delivery time
• Bishop score after catheter expulsion
• Duration of use and dose of oxytocin between amniotomy and delivery
• Mode of delivery
• Umbilical cord prolapse
• Maternal and neonatal morbidity
Background summary
To assess, in term pregnant women with an unfavourable cervix, the time interval between the start of induction of labour and delivery using a Foley’s catheter filled with 30mL of fluid compared with a Foley’s catheter filled with 60mL of fluid.
Study objective
In term pregnant women with an unfavourable cervix (Bishop score < 6, Appendix1) the time interval between induction of labour and birth with a transcervical Foley catheter filled with 60mL is significant quicker and equally safe than with a transcervical Foley catheter filled with 60mL.
Study design
Vaginal swab culture (taken at Foley’s catheter insertion)
Questionnaires after delivery
Intervention
Intervention: Foley catheter filled with 60mL
Control: Foley catheter filled with 30mL
Bronovolaan 5
W.J. van Wijngaarden
Den Haag 2597 AX
The Netherlands
tel: 070 312 4141
e-mail: WvWijngaarden@bronovo.nl
Bronovolaan 5
W.J. van Wijngaarden
Den Haag 2597 AX
The Netherlands
tel: 070 312 4141
e-mail: WvWijngaarden@bronovo.nl
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
Exclusion criteria
• Maternal age <18years
• Severe congenital malformations
• Prior caesarean section
• Placenta praevia
• Hypersensitivity for one of the products used for induction
• Latex allergy
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5345 |
| NTR-old | NTR5578 |
| CCMO | NL44078.098.13 |
| OMON | NL-OMON39008 |