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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

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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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  • Induction of labour increases assisted delivery and caesarean section rate

LVR 2, Vrouenraets Obstet Gyncol 2005


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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


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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


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Inclusion criteria

  • 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

  • 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

Inform patient when scheduled for induction, patient information leaflet

Day of induction

  • CTG

  • Bishop Score

  • Informed consent

  • Randomisation


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Randomisation

  • Transcervical Foley catheter

  • Prostaglandins according to local protocol


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Intervention - Method


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  • 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!!!


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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


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Outcome

Maternal morbidity

  • Hyperstimulation

  • Maternal infection

  • Post partum haemorrhage

    Cost analysis


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Sample size

Reduction of caesarean section rate from 25% to 17%

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


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Hospitals

AMCAmsterdam

SpaarneHoofddorp

Zaans MCZaandam

TweestedenTilburg

Máxima MCVeldhoven

Jeroen Boschs-Hertogenbosch

ElkerliekHelmond

UMCGGroningen

MC LeeuwardenLeeuwarden

LUMCLeiden

Groene HartGouda

MCH WesteindeDen Haag

HAGA ziekenhuisDen Haag

MUMCMaastricht

AmphiaBreda

IkaziaRotterdam

St AntoniusNieuwegein

DiakonessenUtrecht

Meander MCAmersfoort


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Contact information

www.studies-obsgyn.nl/probaat

[email protected]

Marta Jóźwiak

Arts-onderzoeker PROBAAT


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SETI INeS HYPITAT-II

WOMB

TOTEM


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