Cardiometabolic risk after pregnancy with placental dysfunction: intensified versus conventional follow-up care - a feasibility study

Not Applicable

Conditions: hypertensive pregnancy disorders

Registration Number: DRKS00031285

Lead Sponsor: niversitätsklinikum Leipzig, Klinik für Geburtsmedizin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 80

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

• 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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
patient compliance with visit schedule, operationalised as the number of intensified care visits

Secondary Outcome Measures

Name	Time	Method
What is the overall recruitment rate (regardless of the randomization arm)?<br>between both arms:<br>• What is the proportion of informative drop-outs?<br>• What is the proportion of patients who received treatment for hypertension?<br>• What is the proportion of patients who received treatment for dyslipidemia?<br>• What is the proportion of patients who received at least one of the above treatments?<br>• Change in the Homeostasis Model Assessment (HOMA-index) between 48-72 h and 24-month follow-up<br>• Change in the individual 10- and 30-year Framingham Risk Score and its components between 48-72 h and 24-month follow-up?<br>• Change in the cardiac pump function between 48-72 h and 24-month follow-up?<br>