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PRO staglandin or BA lloon for induction of labour A t T erm

PRO staglandin or BA lloon for induction of labour A t T erm. Researcher: Marta J óź wiak Project leaders: Dr K. Bloemenkamp, Dr J.W. de Leeuw, Dr M.G. van Pampus . Project Group. M. Benthem, UMC Groningen Drs. M.G.K. Dijksterhuis, Ikazia Ziekenhuis Rotterdam

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PRO staglandin or BA lloon for induction of labour A t T erm

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  1. PROstaglandin or BAlloon for induction of labour At Term Researcher: Marta Jóźwiak Project leaders: Dr K. Bloemenkamp, Dr J.W. de Leeuw, Dr M.G. van Pampus

  2. Project Group • M. Benthem, UMC Groningen • Drs. M.G.K. Dijksterhuis, Ikazia Ziekenhuis Rotterdam • Dr. J.P.R. Doornbos, Zaans MC • Dr. J.W. de Leeuw, Ikazia Ziekenhuis Rotterdam • Drs. M. Jozwiak, Ikazia Ziekenhuis Rotterdam • Prof. Dr. B.W. Mol, AMC Amsterdam • Dr. M.G.van Pampus, UMC Groningen • Prof.Dr. J.A.M. van der Post, AMC Amsterdam • Dr. K.W.M. Bloemenkamp, LUMC Leiden

  3. Content • Background • Objective • In- and exclusion criteria • Procedure • Outcomes

  4. Rationale • 20-30% of all deliveries are induced • 51,000 induced deliveries in The Netherlands annually • Method? NVOG: vaginal prostaglandin gel PRN 2007, NVOG 2006

  5. Current Practice Methods for induction of labour in Dutch Hospitals 2006 30 26 25 25 20 15 number of hospitals 10 9 10 4 3 5 0 Misoprostol Vaginal insert Prostaglandin gel c Multiple methods Foley and Prosta Prostaglandin gel v Reijers, submitted for publication

  6. Induction of labour increases assisted delivery and caesarean section rate LVR 2, Vrouenraets Obstet Gyncol 2005

  7. Foley catheter vs prostaglandins • Relatively inexpensive method • Comparable success rates • Comparable/lower caesarean section rate • No differences in maternal/neonatal morbidity... Higher infection rate?? previous studies underpowered Sciscione AJOG 1999, Ghezzi EJOG 2001, Boulvain Cochrane 2001, Heinemann AJOG 2008

  8. Objective To investigate the efficacy and safety of induction of labour with a Foley catheter compared to prostaglandins in term pregnant women with an unfavourable cervix

  9. Inclusion criteria • Term pregnancy (≥ 37 weeks gestation) • Scheduled for induction of labour • Vital singleton pregnancy • Intact membranes • Cephalic presentation • Unfavourable cervix (Bishop score <6)

  10. Exclusion criteria • History of caesarean section (separate study!) • Placenta praevia • Fetal anomalies • Contraindication for use of one of the products used for induction of labour

  11. Randomisation procedure Inform patient when scheduled for induction, patient information leaflet Day of induction • CTG • Bishop Score • Informed consent • Randomisation

  12. Randomisation • Transcervical Foley catheter • Prostaglandins according to local protocol

  13. Intervention - Method

  14. If after 24 hours the cervix is unfavourable for amniotomy  another 24 hours of induction • If after second 24 hours the cervix is unfavourable for amniotomy  day of rest, followed by a maximum of another 48 hours of induction NO CROSS-OVER!!!

  15. Outcome Primary outcome • Caesarean section rate Secondary outcome • Assisted delivery rate • Induction to delivery interval • Neonatal morbidity • Apgar Score ≤ 6 after 1 and 5 minutes • Umbilical cord pH ≤ 7.10 • Admission due to suspected infection • Other admissions

  16. Outcome Maternal morbidity • Hyperstimulation • Maternal infection • Post partum haemorrhage Cost analysis

  17. Sample size Reduction of caesarean section rate from 25% to 17% 406 patients in each group (α 0.05, power 80%)

  18. Hospitals AMC Amsterdam Spaarne Hoofddorp Zaans MC Zaandam Tweesteden Tilburg Máxima MC Veldhoven Jeroen Bosch s-Hertogenbosch Elkerliek Helmond UMCG Groningen MC Leeuwarden Leeuwarden LUMC Leiden Groene Hart Gouda MCH Westeinde Den Haag HAGA ziekenhuis Den Haag MUMC Maastricht Amphia Breda Ikazia Rotterdam St Antonius Nieuwegein Diakonessen Utrecht Meander MC Amersfoort

  19. Contact information www.studies-obsgyn.nl/probaat probaat@studies-obsgyn.nl Marta Jóźwiak Arts-onderzoeker PROBAAT

  20. SETI INeS HYPITAT-II WOMB TOTEM

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