Abstract
BackgroundAround 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/designThe 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.DiscussionThis 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.Trial registrationDutch Trial Register and ISRCTN-Register: ISRCTN10363217.
Highlights
Around 80% of intrauterine growth restricted (IUGR) infants are born at term
The lack of consensus on the subject in the Netherlands is demonstrated by the fact that in 2002 in women with a small for gestational age (SGA) child, labour was induced in 32% of these women, whereas labour started spontaneously in 56% of these women, the remaining 11% had an elective caesarean section
These data are based on actual birth weight, and the clinical situation is even more complicated by the fact that the antenatal diagnosis of a SGA child is often difficult to make and missed in clinical practice. In view of this clinical dilemma, we propose a randomised clinical trial in which induction of labour is compared with expectant monitoring in women with a suspected IUGR child at term
Summary
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. The long term morbidity ranges from behavioral problems and minor developmental delay to spastic cerebral palsy [510]. Meconium aspiration, fetal heart rate abnormalities and low Apgar score, more admittances to and longer stays at neonatal intensive care units are reported. This might partly be related to a higher prevalence of hypoglycaemia, neonatal sepsis, hypothermia and haematological problems as thrombocytopenia and polycythemia in these neonates [12,13,14]
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