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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 l.jpg

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


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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


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Content

  • Background

  • Objective

  • In- and exclusion criteria

  • Procedure

  • Outcomes


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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


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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


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LVR 2, Vrouenraets Obstet Gyncol 2005


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Foley catheter vs prostaglandins caesarean section rate

  • 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


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Objective caesarean section rate

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


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Inclusion criteria caesarean section rate

  • Term pregnancy (≥ 37 weeks gestation)

  • Scheduled for induction of labour

  • Vital singleton pregnancy

  • Intact membranes

  • Cephalic presentation

  • Unfavourable cervix (Bishop score <6)


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Exclusion criteria caesarean section rate

  • History of caesarean section (separate study!)

  • Placenta praevia

  • Fetal anomalies

  • Contraindication for use of one of the products used for induction of labour


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Randomisation procedure caesarean section rate

Inform patient when scheduled for induction, patient information leaflet

Day of induction

  • CTG

  • Bishop Score

  • Informed consent

  • Randomisation


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Randomisation caesarean section rate

  • Transcervical Foley catheter

  • Prostaglandins according to local protocol


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Intervention - Method caesarean section rate


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Outcome caesarean section rate

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


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Outcome caesarean section rate

Maternal morbidity

  • Hyperstimulation

  • Maternal infection

  • Post partum haemorrhage

    Cost analysis


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Sample size caesarean section rate

Reduction of caesarean section rate from 25% to 17%

406 patients in each group (α 0.05, power 80%)


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Hospitals caesarean section rate

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


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Contact information caesarean section rate

www.studies-obsgyn.nl/probaat

probaat@studies-obsgyn.nl

Marta Jóźwiak

Arts-onderzoeker PROBAAT


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SETI caesarean section rate INeS HYPITAT-II

WOMB

TOTEM