Disproportionate Intrauterine Growth Intervention Trial At Term (DIGITAT): long-term follow-up

This study is a follow-up study of the Disproportionate Intrauterine Growth
Intervention Trial at Term (DIGITAT), a prospective multicentre randomised
study performed between 2004 and 2008. The aim of this study was to investigate
whether the induction policy in pregnancies complicated with growth restriction
between 36 and 41 weeks can influence outcome. A total of 650 women were
randomised between induction and expectant monitoring. 452 Women refused
randomisation but consented with the use of their medical data. Demographic
data, data from the medical records of the mothers, data concerning the
pregnancy and labour and neonatal outcome were collected. All data were coded
and stored in a central digital database and in digital databases of all
participating centers respectively.

Parents of 2-year-old children included in the Disproportionate Intrauterine
Growth Intervention Trial at Term (DIGITAT) answered the Ages and Stages
Questionnaire (ASQ) and Child Behavior Checklist (CBCL). Parents of 291
children responded. Data from the paper questionnaires were collected in the
digital DIGITAT database.

No data of long-term follow-up studies of randomized intervention trials for
the common problem of FGR are published or currently undertaken. Therefore we
aim to perform this important follow-up study at 10-14 years to investigate
whether in the long term the worldwide early induction strategy that was
implemented after DIGITAT is indeed the optimal strategy. This important
follow-up study will guide pregnancy management for FGR.

- To investigate the long-term outcome of the intervention strategy for FGR
(induction of labour) that is worldwide applied after the original DIGITAT
study, in relation to induction of labour versus expectant management.
- To investigate neurocognitive behaviour and development and the allergic
constitution of children, in relation to induction of labor or an expectant
management.

We will conduct a mono-center follow-up study of the original (multi-center)
randomized controlled trial: DIGITAT. Parents will be contacted to participate
in a follow-up of their children at 10 to 14 years of age. Both patients who
were randomised in the DIGITAT (n=650) and patients who refused randomisation
but consented with the use of their medical data (n=452) will be contacted.
Patients will initially be approached by their local center with a brief
summary of the follow-up study. If they want to participate or would like to
receive additional information, the further course of this follow-up study will
be coordinated from the UMCG. The questionnaires will be distributed, collected
and analyses by the researchteam in the UMCG.
We will use digital questionnaires to collect data on neuro-cognitive
development and behaviour data on allergic constitution of the children.
General medical data of the mothers and children will be collected as well.

The only burden is the time needed to fill in the extensive questionnaires:
60-75 minutes.