Fetal ECG in Diabetes Study
Research type
Research Study
Full title
Investigation of the effect of maternal diabetes on fetal cardiac rhythm: a prospective case-control study.
IRAS ID
186204
Contact name
Catherine Williamson
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
2 years, 11 months, 15 days
Research summary
Diabetes in pregnancy is increasingly common and includes pre-gestational diabetes (i.e. type 1 and type 2 diabetes) and gestational diabetes. Diabetes is considered to be a high-risk condition for both the mother and the baby, and the association between maternal hyperglycaemia and adverse perinatal outcomes, including stillbirth, is now well accepted. The aetiology of stillbirth in diabetes is complex and multifactorial. Post mortem examinations of stillborn babies support the hypothesis that it may be the result of an abnormal cardiac rhythm resulting from structural abnormalities in the fetal heart.
This study aims to assess whether diabetes in pregnancy is associated with abnormal fetal heart rhythms. Fetal heart rhythms will be recorded using a portable electrocardiogram (ECG) device, the Monica AN24. This device monitors the maternal and fetal heart via stickers applied to the mother's abdomen. Women will be asked to wear the device for up to 20 hours at recruitment, and for up to 20 hours weekly thereafter until the birth of their baby. Women will also be asked to donate a blood sample on the days that they wear the monitor, and this will be used to measure glucose and HbA1c, a marker of diabetic control. We will also study women with uncomplicated pregnancy, in order to make comparisons.
REC name
London - Fulham Research Ethics Committee
REC reference
16/LO/0839
Date of REC Opinion
30 Jun 2016
REC opinion
Further Information Favourable Opinion