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PROBAAT

 

Prostaglandin or Balloon for Induction of labour at Term

 

Go to the Probaat website.

 

Results

Transcervical Foley catheter induction is as effective as vaginal prostaglandin E2 gel induction in terms of caesarean section. Fewer instrumental deliveries for foetal distress are performed when using a Foley catheter. Furthermore there is a tendency towards less maternal and neonatal hyperstimulation-related morbidity, and significantly less neonates are admitted after Foley catheter induction. Therefore Foley catheter induction should be considered first method of choice for induction of labour in case of an unfavourable cervix at term.


Background

Induction of labour is an intervention designed to artificially initiate uterine contractions leading to progressive dilatation and effacement of the cervix and birth of the baby. Induction of labour is a common procedure: twenty-two percent of all deliveries were induced in the Netherlands in 2007. Compared to the spontaneous onset of labour, induction of labour is associated with prolonged labour, more instrumental deliveries and a higher rate of caesarean sections, especially when the cervix is unfavourable.

A recent Dutch survey showed a wide variety of methods being in use for induction of labour, intravaginal prostaglandin gel being used most frequently. A less frequently utilized method of ripening the uterine cervix is the transcervical Foley catheter. This inexpensive method is reported to have similar success-rates to induction of labour with intravaginal prostaglandins, and is associated with fewer abnormalities of contraction pattern and a lower caesarean section rate.

 

Objective

To assess in term pregnant women with an unfavourable cervix (Bishop score < 6) the effectiveness of induction of labour with a transcervical Foley catheter as compared to induction with prostaglandins.

 

Study design

Multicentre prospective randomised controlled trial. The study will be performed within a consortium of perinatal centres, that are collaborating in several proposed studies.

 

Study population

Term pregnant women with an indication for induction of labour

 

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:

- Previous caesarean section

- Placenta praevia

- Hypersensitivity for one of the products used for induction

 

Intervention

Induction of labour with a transcervical Foley catheter as opposed to intravaginal prostaglandins.

 

Main study parameters/endpoints

Caesarean section rate. Secondary outcomes will be maternal and neonatal morbidity and costs.

 

Analysis and sample size

Analysis will be by intention to treat. We need two groups of 406 women (812 women) to demonstrate a reduction in caesarean section rate from 25% to 17%

 

Economic evaluation

For each of the two strategies, we will calculate costs of perinatal care. In case of equal neonatal and maternal outcome the analysis will be a cost-minimisation analysis.

 

Time schedule

30 months. Three months preparation. Twenty-four months inclusion. Three months analysis and report.

 

Project leader

Dr. J.W. de Leeuw, Ikazia Ziekenhuis Rotterdam

 

Project group

Drs. M.G.K. Dijksterhuis, Ikazia Ziekenhuis Rotterdam

Dr. J.W. de Leeuw, Ikazia Ziekenhuis Rotterdam

Drs. M. Jozwiak, Ikazia Ziekenhuis Rotterdam

Dr. S. Scherjon, LUMC Leiden

Prof. Dr. B.W. Mol, AMC Amsterdam

Dr. J.A.M. van der Post, AMC Amsterdam

Dr. M.G.van Pampus, UMC Groningen

M. Benthem, UMC Groningen