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…
ID
Bron
Verkorte titel
Aandoening
- Inleiding van de baring
- Foley katheter
- Induction of labour
- Foley catheter
Ondersteuning
Bronovolaan 5, 2597 AX Den Haag
tel: 070 312 4141
e-mail: WvWijngaarden@bronovo.nl
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The main study parameter is delivery versus no delivery within 8 hours after the membranes are artificially ruptured.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Vaginal swab culture (taken at Foley’s catheter insertion)
Questionnaires after delivery
Onderzoeksproduct en/of interventie
Intervention: Foley catheter filled with 60mL
Control: Foley catheter filled with 30mL
Algemeen / deelnemers
Bronovolaan 5
W.J. van Wijngaarden
Den Haag 2597 AX
The Netherlands
tel: 070 312 4141
e-mail: WvWijngaarden@bronovo.nl
Wetenschappers
Bronovolaan 5
W.J. van Wijngaarden
Den Haag 2597 AX
The Netherlands
tel: 070 312 4141
e-mail: WvWijngaarden@bronovo.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Term pregnancy (≥37 weeks of pregnancy)
• Scheduled for induction of labour
• Vital singleton pregnancy
• Intact membranes
• Unfavourable cervix (Bishop score < 6)
• Cephalic presentation
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Maternal age <18years
• Severe congenital malformations
• Prior caesarean section
• Placenta praevia
• Hypersensitivity for one of the products used for induction
• Latex allergy
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5345 |
| NTR-old | NTR5578 |
| CCMO | NL44078.098.13 |
| OMON | NL-OMON39008 |