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DIGITAT

 

Disproportionate Intrauterine Growth Intervention Trial At Term

Go to the
DIGITAT page

Objective
Small babies with intrauterine growth failure are at increased risk of direct adverse neonatal outcome. In The Netherlands, >9.000 women deliver a baby below the 10th birth weight percentile (SGA). At present, no unanimity exists among obstetricians, regarding benefits of induction of labour to realise earlier delivery or wait for spontaneous delivery. Induction may result in complications during delivery; expectant monitoring provides a maximal chance of spontaneous labour, however at the expense of possible complications for the child. Both strategies might have impact on maternal quality of life, and there is no reliable information whatsoever on the costs of both strategies.

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

Study population
Women are eligible for the study if the carry a singleton SGA foetus (in cephalic position) at 36 completed weeks (or more).

Intervention
Induction of labour at 35 completed weeks or later (interventionprotocol) or expectant monitoring. In case of expectant monitoring,vital parameters of the child will be monitored until the onset of spontaneous labour or until there are signs of a intra-uterine distress (expectant monitoring group).


Outcome measures
Main outcome will be a composite bad neonatal outcome defined as foetal death, a 5 minute Apgar score below 7, an umbilical artery pH below7.05 and/or admission to the neonatal intensive care. Secondary outcomes will be severe maternal morbidity, maternal quality of life and costs.

Power/data analysis
Based on an incidence of 15% of poor neonatal outcome, we need 275patients in each arm to exiled large difference between neonatal outcome (power 50% to exclude a difference larger than 5%. In case of equivalent maternal and neonatal outcome, the study will compare quality of life of the mother and costs. Assuming an average difference in cost of 1.000 per patient to be relevant, we will need 626 women to be randomised (313 per arm). Thus, the study aims to recruit 626 patients.

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 willbe a cost-minimisation analysis.

Time schedule
36 months. Three months preparation. Thirty months inclusion. Three months analysis and report.

Projectleaders
Dr. S.A. Scherjon, gynaecologist, LUMC Leiden
Dr. B.W. Mol, gynaecologist, MMC Veldhoven

Health Technology Assessment
Prof. Dr. G.J. Bonsel, AMC Amsterdam

Methodology
Dr. S. Le Cessie, epidemiologist LUMC
Dr. E. Birnie, health economist, AMC
Drs. D. Bijlenga, AMC
Drs. K.E. Boers, LUMC
Drs. S.M.C. Vijgen, AMC

Subsidy
ZonMw -
www.zonmw.nl