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 Wat bevalt beter



Prostaglandin or Balloon catheter for induction of labour after previous caesarean section

Go to the PROBAAT-S website

Women with a previous caesarean section entering a trial of labour have an increased risk of repeat caesarean section, especially when labour is induced. In the Netherlands, labour in women with a previous caesarean section is mostly induced with a transcervical Foley catheter or with intravaginal prostaglandin gel when the cervix is unfavourable. When the cervix is favourable, labour may be induced by amniotomy. Some hospitals do not induce labour at all in women with a previous caesarean section and thus perform an elective repeat caesarean section. The best method of induction of labour in this group of women is still controversial. Induction by Foley catheter and especially prostaglandins are associated with increased uterine scar rupture rate. To date, studies have focused on uterine scar rupture rate or caesarean rate when comparing prostaglandins to Foley catheter for induction of labour. Studies concerning induction of labour by Foley catheter show its efficacy and safety although they include cohorts not larger than n=161.

To study the methods of induction of labour in women with a previous caesarean section and their respective effectiveness and safety, i.e. neonatal and maternal morbidity in the Netherlands.

Study design
A national prospective observational cohort study.

Study population
Pregnant women with a history of one previous caesarean section and an indication for induction of labour in the current pregnancy.

All women with one previous caesarean section and an indication for induction of labour will be treated according to their local hospital protocol who may induce by prostaglandins, Foley catheter, amniotomy or oxytocine. Hospitals that do not induce labour in this group of women perform a repeat caesarean section. All women will be registered and information concerning their (obstetrical) history, pregnancy, mode of delivery and puerperium will be collected as well as neonatal data until discharge. All data will be collected anonymously in a web-based file.

Outcome measures
Primary outcome will be neonatal and maternal morbidity. Secondary outcome measures will be mode of delivery, including subanalysis of Foley catheter versus prostaglandins, induction-to-delivery interval and costs.

We aim to include 1500 women in a two-year period starting on August 1st 2011.    
Time schedule
36 months. 6 months preparation, 24 months inclusions, 6 months data analysis.

Dr. Bloemenkamp, gynaecologist, Leiden University Medical Centre, Leiden


Drs. M. Józwiak, Groene Hart Ziekenhuis, Gouda
Dr J.W. de Leeuw, Ikazia Ziekenhuis Rotterdam
Dr. B.W. Mol, Academic Medical Centre, Amsterdam
Dr. M.G.van Pampus, OLVG Amsterdam
Dr. A. Kwee, UMCU, Utrecht
Prof. dr J. van Roosmalen, LUMC, Leiden

Grant from ”Werkgroep Perinatologie en Maternale Ziekten (working party of
    Dutch Society of Obstetrics and Gynaecology).
Grant from Dutch Consortium in Obstetrics, Fertility and Gynaecology.

Drs. Claartje Huisman, 
Main researcher
Leiden University Medical Centre

Contact information:
Postal address:
Afdeling Verloskunde K-06-P/35
Postbus 9600
2300 RC Leiden
Telephonenumber: +31-6-46 08 82 35
Faxnumber: 071-526 6741