Blood Pressure, Antihypertensive Treatment and Preeclampsia in Pregnant Wom-en With Pre-existing Diabetes
Status:
Completed
Trial end date:
2021-02-01
Target enrollment:
Participant gender:
Summary
Aim: First, to investigate the prevalence of a) confirmed hypertension, b) white coat
hypertension and c) normal blood pressure in pregnant women with pre-existing diabetes.
Second, to explore the prevalence of preeclampsia and preterm delivery in women with
pre-existing diabetes with a) confirmed hypertension, b) white coat hypertension and c)
normal blood pressure before entering the third trimester of pregnancy. Third, to explore the
influence of lifestyle, gestational weight gain and mental well-being on confirmed
hypertension and preeclampsia in pregnant women with diabetes.The recruitment period was in
2018 extended to 2020 to perform the following studies: First whether home BP in early
pregnancy is superior to office BP to predict preeclampsia. Second to evaluate the prevalence
of preeclampsia after initiation of a new treatment strategy including prophylactic aspirin
and, in case of insufficiency, vitamin D supplementation.
Design: A prospective multicentre observational study where approximately 400 pregnant women
with pre-existing diabetes are offered measurements of office blood pressure (BP) and home BP
for three days three times during pregnancy as well as when the routinely measured office BP
exceeds 135/85 mmHg. The prevalence of confirmed hypertension (office BP >135/85 mmHg and
home BP >130/80 mmHg) and white coat hypertension (office BP >135/85 mmHg but home BP ≤130/80
mmHg) will be determined. Women with confirmed hypertension are offered antihypertensive
treatment mainly with methyldopa. In women with a) confirmed hypertension, b) white coat
hypertension, and c) normal blood pressure before entering third trimester of pregnancy, the
prevalence of preeclampsia and preterm delivery will be evaluated. Possible side effects of
antihypertensive treatment including impaired fetal haemodynamics and lower infant birth
weight will be recorded. The women will complete food diaries and questionnaires on lifestyle
and mental health three times in pregnancy in order to evaluate the influence of these
parameters on hypertension and preeclampsia.