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‘Foley catheter for induction of labour filled with 30mL or 60mL’


- candidate number23474
- NTR NumberNTR5578
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-dec-2015
- Secondary IDsNL44078.098.13 METC-Zuidwest Holland
- Public Title‘Foley catheter for induction of labour filled with 30mL or 60mL’
- Scientific Title‘Foley catheter for induction of labour filled with 30mL or 60mL’
- ACRONYMFILL study
- hypothesisIn 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.
- Healt Condition(s) or Problem(s) studied
- 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2014
- planned closingdate1-jan-2015
- Target number of participants0
- InterventionsIntervention: Foley catheter filled with 60mL
Control: Foley catheter filled with 30mL
- Primary outcomeThe 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
- TimepointsVaginal swab culture (taken at Foley’s catheter insertion) Questionnaires after delivery
- Trial web sitenone
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES W.J. van Wijngaarden
- CONTACT for SCIENTIFIC QUERIES W.J. van Wijngaarden
- Sponsor/Initiator Bronovo Hospital
- Funding
(Source(s) of Monetary or Material Support)
Fund = Initiator = Sponsor
- Publications--
- Brief summaryTo 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.
- Main changes (audit trail)
- RECORD9-dec-2015 - 14-feb-2016


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