Blood Pressure, Antihypertensive Treatment and Preeclampsia in Pregnant Wom-en With Pre-existing Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 513
- 试验地点
- 1
- 主要终点
- White coat hypertension
研究概览
简要总结
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.
详细描述
Design: Home blood pressure and office blood pressure as predictors of preeclampsia will be evaluated in the total cohort. From February 2018, the routine care includes treatment with prophylactic aspirin in all women with pre-existing diabetes and screening for vitamin D insufficiency, treated with vitamin D depending on the severity of the insufficiency. The prevalence of preeclampsia after initiation of the new treatment strategy will be evaluated. The women included from 2016-2018, where aspirin was only initiated if other risk factors to preeclampsia apart from diabetes were present, will be used for comparison.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for pregnant women with diabetes:
- •Women with pre-existing diabetes, older than 18 years and referred to The Center for Pregnant Women with Diabetes, Rigshospitalet, or the Centre for Diabetes and Pregnancy, Odense University Hospital, with a live singleton or twin pregnancy before 20 weeks during the inclusion period.
- •Women with diabetes diagnosed in pregnancy before 20 weeks (HbA1c ≥48 mmol/mol) may also be included as having type 2 diabetes.
- •Sufficient Danish language skills to read and understand the patient information sheet and to converse.
- •Inclusion criteria for pregnant healthy women without diabetes:
- •Women above 18 years of age, with a live singleton pregnancy, referred to a nuchal translucency scan at 11-14 weeks at The Department of Obstetrics, Rigshospitalet.
- •Sufficient Danish language skills to read and understand the patient information sheet and to converse.
排除标准
- •Exclusion criteria for both study groups:
- •Women diagnosed with severe diseases that could possibly bias BP measurements or pregnancy outcome. This is judged by the principal investigators.
研究组 & 干预措施
Pregnant women with pre-existing diabetes
Inclusion of 400 women is anticipated.
干预措施: Antihypertensiva, mainly Metyldopa (Drug)
结局指标
主要结局
White coat hypertension
时间窗: 2 years
Office blood pressure \>135/85 mmHg measured twice at least 4 hours apart, but home blood pressure ≤130/80 mmHg
Confirmed hypertension
时间窗: 2 years
Office blood pressure \>135/85 mmHg measured twice at least 4 hours apart and home blood pressure \>130/80 mmHg in pregnancy, or diagnosed hypertension with antihypertensive treatment from before pregnancy
Preeclampsia
时间窗: 4 years
Early preeclampsia
时间窗: 4 years
Preeclampsia occurring before 34 weeks
Preterm birth
时间窗: 4 years
Birth before 37 completed weeks
Early preterm delivery (international)
时间窗: 4 years
Birth before 32 completed weeks
Early preterm delivery (Danish)
时间窗: 4 years
Birth before 34 completed weeks
次要结局
- Gestational hypertension(4 years)
- Chronic hypertension(4 years)
研究者
Marianne Vestgaard
MD, Ph.D student
Rigshospitalet, Denmark