Cardiovascular changes in High Risk pregnancy
Research type
Research Study
Full title
Cardiovascular changes in High risk pregnancy
IRAS ID
182250
Contact name
Hatem Mousa
Contact email
Sponsor organisation
University Hospitals of Leicester
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
We hypothesise that Gestational Diabetes has a greater impact on the maternal cardiovascular system (CVS) than currently understood. We will examine maternal cardiovascular changes among diabetic pregnant women on metformin. In addition we would like to evaluate the correlation between CVS changes and pregnancy outcome.
We plan:
1. To examine the potential value of early maternal cardiovascular changes in prediction of pregnancy complications.
2. To investigate long-term postpartum cardiovascular changes in women who have experienced adverse pregnancy outcomes.
3. To ascertain the effect of routinely-used glucose lowering agents on these cardiovascular parameters.
4. To validate the various non-invasive methods of cardiovascular assessment against the gold standard of invasive monitoring.
5. To investigate the effect of glucose lowering agents during pregnancy on uterine artery and fetal doppler studies and correlate the findings to pregnancy outcome.
6. To examine the influence of labour and anaesthesia on maternal cardiovascular changes in diabetic women on glucose lowering therapy and on pregnant women without diabetes
7. To assess the relationship between arterial stiffness, endothelial dysfunction and maternal anthropometry measures in the form of BMI, waist-hip measurements, weight and skin fold thickness in pregnant women on glucose lowering therapy and compare it to controls.
Participants in the study and control arms will be monitored during their pregnancy and 3 months postpartum. Demographic data and outcome measures from their pregnancy will be documented and trends investigated by evaluating this data.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
15/EM/0469
Date of REC Opinion
27 Nov 2015
REC opinion
Further Information Favourable Opinion