Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT.
BACKGROUND
Around 80% of intrauterine growth restricted (IUGR) infants are born at term. They have an increase in perinatal mortality and morbidity including behavioral problems, minor developmental delay and spastic cerebral palsy. Management is controversial, in particular the decision whether to induce labour or await spontaneous delivery with strict fetal and maternal surveillance. We propose a randomised trial to compare effectiveness, costs and maternal quality of life for induction of labour versus expectant management in women with a suspected IUGR fetus at term.


METHODS
The proposed trial is a multi-centre randomised study in pregnant women who are suspected on clinical grounds of having an IUGR child at a gestational age between 36+0 and 41+0 weeks. After informed consent women will be randomly allocated to either induction of labour or expectant management with maternal and fetal monitoring. Randomisation will be web-based. The primary outcome measure will be a composite neonatal morbidity and mortality. Secondary outcomes will be severe maternal morbidity, maternal quality of life and costs. Moreover, we aim to assess neurodevelopmental and neurobehavioral outcome at two years as assessed by a postal enquiry (Child Behavioral Check List-CBCL and Ages and Stages Questionnaire-ASQ). Analysis will be by intention to treat. Quality of life analysis and a preference study will also be performed in the same study population. Health technology assessment with an economic analysis is part of this so called Digitat trial (Disproportionate Intrauterine Growth Intervention Trial At Term). The study aims to include 325 patients per arm.


CONCLUSIONS
This trial will provide evidence for which strategy is superior in terms of neonatal and maternal morbidity and mortality, costs and maternal quality of life aspects. This will be the first randomised trial for IUGR at term.


BACKGROUND
Dutch Trial Register and ISRCTN-Register: ISRCTN10363217.
Boers
Kim E
KE
Department of Obstetrics and Gynaecology, Leiden University Medical Center, The Netherlands. k.e.boers@lumc.nl
Bijlenga
Denise
D
Mol
Ben W J
BW
LeCessie
Saskia
S
Birnie
Erwin
E
van Pampus
Marielle G
MG
Stigter
Rob H
RH
Bloemenkamp
Kitty W M
KW
van Meir
Claudia A
CA
van der Post
Joris A M
JA
Bekedam
Dick J
DJ
Ribbert
Lucy S M
LS
Drogtrop
Addie P
AP
van der Salm
Paulien C M
PC
Huisjes
Anjoke J M
AJ
Willekes
Christine
C
Roumen
Frans J M E
FJ
Scheepers
Hubertina C J
HC
de Boer
Karin
K
Duvekot
Johannes J
JJ
Thornton
Jim G
JG
Scherjon
Sicco A
SA
D000328:Adult; D016001:Confidence Intervals; D003365:Costs and Cost Analysis; D005260:Female; D005317:Fetal Growth Retardation / Q000191:economics* / Q000453:epidemiology; D006801:Humans; D007229:Infant Welfare / Q000191:economics* / Q000706:statistics & numerical data; D007231:Infant, Newborn; D007751:Labor, Induced / Q000191:economics* / Q000379:methods; D008429:Maternal Welfare / Q000191:economics* / Q000706:statistics & numerical data; D011247:Pregnancy; D011256:Pregnancy Outcome / Q000191:economics* / Q000453:epidemiology; D011446:Prospective Studies; D011788:Quality of Life; D047929:Term Birth