Clinical Trial: Blood Pressure, Antihypertensive Treatment and Preeclampsia in Pregnant Wom-en With Pre-existing Diabetes

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Blood Pressure, Antihypertensive Treatment and Preeclampsia in Pregnant Wom-en With Pre-existing Diabetes

Brief 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.

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.


Detailed Summary:
Sponsor: Rigshospitalet, Denmark

Current Primary Outcome:

  • Confirmed hypertension [ Time Frame: 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
  • White coat hypertension [ Time Frame: 2 years ]
    Office blood pressure >135/85 mmHg measured twice at least 4 hours apart, but home blood pressure ≤130/80 mmHg
  • Preeclampsia [ Time Frame: 2 years ]
  • Early preeclampsia [ Time Frame: 2 years ]
    Preeclampsia occurring before 34 weeks
  • Preterm birth [ Time Frame: 2 years ]
    Birth before 37 completed weeks
  • Early preterm delivery (international) [ Time Frame: 2 years ]
    Birth before 32 completed weeks
  • Early preterm delivery (Danish) [ Time Frame: 2 years ]
    Birth before 34 completed weeks


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Gestational hypertension [ Time Frame: 2 years ]
    De novo hypertension appearing after 20 weeks
  • Chronic hypertension [ Time Frame: 2 years ]
    Hypertension diagnosed prior to pregnancy, or during pregnancy before 20 weeks


Original Secondary Outcome: Same as current

Information By: Rigshospitalet, Denmark

Dates:
Date Received: August 31, 2016
Date Started: February 2016
Date Completion: February 2019
Last Updated: August 31, 2016
Last Verified: August 2016