hypertensive pregnancy disorders
Conditions
Interventions
Group 1: intensified care, follow-up after 6, 12 and 24 months
Group 2: conventional care, follow-up after 24 months
Sponsors
Universitätsklinikum Leipzig, Klinik für Geburtsmedizin
Eligibility
Sex/Gender
Female
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: • clear allocation to the risk group of hypertensive pregnancy disorders or placental dysfunction, i.e., at least one of the following: - Preeclampsia - Gestational hypertension or pregnancy-induced hypertension (PIH) - Chronic hypertension - Intrauterine growth restriction (IUGR) • singleton pregnancy • permanent residence in Leipzig and the surrounding area • written informed consent
Exclusion criteria
Exclusion criteria: • patients with pre-existing (surgically corrected) structural heart defects or heart failure • patients with pre-existing nephropathies/ glomerulonephritis • patients with pre-existing diabetes mellitus • patients with known vasculitides and/or collagenoses • patients with any type of lipid lowering agents and diuretics • fetal chromosomal aberrations or genetic defects associated with fetal growth restriction • suspected fetal major structural defects (e.g., heart failures) that may lead to fetal ascites and hydrops fetalis and therefore, are associated with maternal mirror syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| patient compliance with visit schedule, operationalised as the number of intensified care visits | — |
Secondary
| Measure | Time frame |
|---|---|
| What is the overall recruitment rate (regardless of the randomization arm)? between both arms: • What is the proportion of informative drop-outs? • What is the proportion of patients who received treatment for hypertension? • What is the proportion of patients who received treatment for dyslipidemia? • What is the proportion of patients who received at least one of the above treatments? • Change in the Homeostasis Model Assessment (HOMA-index) between 48-72 h and 24-month follow-up • Change in the individual 10- and 30-year Framingham Risk Score and its components between 48-72 h and 24-month follow-up? • Change in the cardiac pump function between 48-72 h and 24-month follow-up? | — |
Countries
Germany
Contacts
Public ContactAnett Schmiedeknecht
Zentrum für Klinische Studien Leipzig
Outcome results
None listed