Pregnant women with type 1 diabetes mellitus are at increased risk of developing
pre-eclampsia, which presents as hypertension or high blood pressure and
proteinuria (protein present in urine). Somewhere between 13 and 30% of pregnant
women with diabetes will develop high blood pressure during pregnancy, and this is
a major cause of hospital admissions.
Pre-eclampsia is an important cause of premature delivery and low birth weight in
babies, and at present delivery of the baby is the only known cure. A reduction in the
rate of pre-eclampsia would therefore have major benefits in terms of improving the
health of both the mother and the baby.
At present, the cause of pre-eclampsia is not fully understood. However, it has been
suggested that it is, in part, due to a poor blood supply to the placenta. This may be
due to the production of harmful chemicals called free radicals which damage the
cells lining the blood vessels in the placenta.
Recently it has been suggested that taking supplements of vitamin C and vitamin E
during pregnancy may prevent the production of harmful free radicals and thus
reduce the risk of pre-eclampsia. A study in 283 women without diabetes showed
that taking supplements of vitamin C and vitamin E reduced the occurrence of preeclampsia from 17% to 8% (Chappell et al. Lancet 1999; 354: 810-816). However,
there were no women with diabetes in this study and it is unclear whether a similar
benefit will be found in the presence of diabetes.
Study Aim: To determine whether supplementation with vitamin C and vitamin E
from early pregnancy will reduce the risk of developing pre-eclampsia in pregnant
women with type 1 diabetes.
Study Design: Double-blind randomised multicentre placebo-controlled trial
Intervention: Vitamin C 1000mg and Vitamin E 400IU or placebo tablets daily
Patients: 756 women from 3 UK regions will be recruited to participate in this trial
Eligibility: Women with type 1 diabetes preceding pregnancy, presenting between 8
and 22 weeks gestation
Primary outcome: Incidence of pre-eclampsia
Secondary outcomes: endothelial activation; birthweight centile
Study Duration: Recruitment commenced in March 2003. The trial is now fully
recruited. The last baby was delivered in December 2008. The trial report is
expected early in 2010.
DAPIT Protocol Version 1.2: Click here to view protocol.
Funding Source: The Wellcome Trust
ISRCTN27214045
DAPIT Centres:
Northern Ireland: Belfast
Royal Jubilee Maternity Service (Dr David McCance)
Ulster Hospital, Dundonald (Dr Roy Harper)
Craigavon
Craigavon Area Hospital (Dr Kate Ritchie)
North-West
Altnagelvin Hospital (Dr Ken Moles)
Antrim
Antrim Area Hospital (Dr Adele Kennedy)
Scotland:
Edinburgh
Edinburgh Royal Infirmary (Dr Alan Patrick)
Western General Hospital, Edinburgh (Dr Corinne Love)
St John’s Hospital, Livingston (Dr James Walker)
Glasgow
Princess Royal Maternity Hospital, Glasgow (Dr Ken Paterson)
Queen Mother’s Maternity Hospital, Glasgow (Dr Alan Cameron)
Southern General Hospital, Glasgow (Dr Andy Gallagher)
Central Scotland
Wishaw General Hospital (Dr Dina McLellan)
Forth Valley
Stirling Royal Infirmary (Dr Hilary MacPherson)
Falkirk & District Royal Infirmary (Dr Hilary MacPherson)
Dundee
Ninewells Hospital, Dundee (Dr Graham Leese)
Aberdeen
Aberdeen Maternity Hospital (Dr Donald Pearson)
Fife
Forth Park Maternity Hospital (Dr Rennie Urquhart)
NW England:
Manchester
St Mary’s Hospital for Women & Children (Dr Mike Maresh)
Hope Hospital, Salford (Dr Bob Young)
Liverpool
Liverpool Women’s Hospital (Mr Steve Walkinshaw)
Aintree University Hospital (Dr Ian Casson)
Birmingham / West Midlands
Birmingham Women’s Hospital (Mr Harry Gee)
Good Hope Hospital (Dr John Milles)
City Hospital (Dr Ansu Basu)
Walsall Hospital (Mrs Balachandar)
If you require further information regarding the trial, or wish to be put in contact with one of
the DAPIT Research Midwives at any of the participating centres, please contact the
DAPIT Clinical Coordinating Centre on 028 9063 2524.
DAPIT Trial Coordinator: Dr Valerie Holmes, DAPIT, Institute of Clinical Sciences,
Block B, Grosvenor Road, Belfast BT12 6BW
Email: v.holmes@qub.ac.uk Telephone: 028 9063 2524
Principal Investigator: Dr David R McCance, Consultant Physician / Honorary
Senior Lecturer, Regional Centre for Endocrinology and Diabetes, Royal Victoria
Hospital, Belfast BT12 6BA
Investigators page (available to study members only)