Intra Uterine Pressure Catheter
The results of the IUPC study showed that internal tocodynamometry during induced or augmented labor, as compared with external monitoring, did not significantly reduce the rate of operative deliveries or of adverse neonatal outcomes. See full article: N Engl J Med 2010; 362:306-13.
Protocol IUPC nov. 2004 (Word)
In The Netherlands, approximately 10.000 deliveries are induced and15.000 deliveries are augmented with intravenous oxytocin each year(LVR 2, 2002). The guideline of the Dutch Society of Gynaecology andObstericians advices to use an intra uterine pressure catheter (IUPC)to monitor frequency and strength of contractions. (NVOG-richtlijn no5: Inleiden van de baring, February 1997. www.nvog.nl)
There is however no scientific evidence that monitoring contractionswith IUPC is beneficial in terms of maternal or fetal outcome andwhether it is cost effective. The aim of our study is to evaluate theeffectiveness of IUPC in comparison to external monitoring duringinduction of labour.
Multicentre prospective randomised controlled trial. The study will beperformed within a consortium of five perinatal centres, which arecollaborating in several proposed studies.
Women are eligible for the study if labour is induced or augmented with intravenous oxytocin.
Women will be at random allocated to placement of an IUPC (interventiongroup) or external uterine activity monitoring (control group). Therewill be stratifed for centre, parity and induction or augmentation.
Main outcome will be the neonatal condition defined as a 5 minute Apgarscore below 7, an umbilical artery pH below 7.05 and/or admission tothe neonatal intensive care. Secondary outcomes will be complications,the number of instrumental deliveries, i.e. caesarean sections and/orassisted vaginal delivery, need for antibiotics by mother or child,total amount of oxytocin used, time to delivery and costs.
Power/ data analysis
The study will be designed as anequivalence study. Analysis will be by intention to treat. We will need1000 women in each arm (overall 2000 women). In a second analysis, wewill assess the effectiveness of IUPC in those women in whom thetechnique could be applied according to protocol. In case of equalneonatal and maternal outcome the analysis will be a cost-minimisationanalysis.
Dr. J.A.M.van der Post, gynaecologist, AMC Amsterdam
Dr. B.W. Mol, gynaecologist, AMC Amsterdam
Amsterdam - Academisch Medisch Centrum
Amsterdam - Onze Lieve Vrouwe Gasthuis
Amsterdam - Slotervaart ziekenhuis
Leiden - Leiden Universitair Medisch Centrum
Veldhoven - Maxima Medisch Centrum