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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02754778
Other study ID # RedCarRisk-Study
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2016
Est. completion date March 2021

Study information

Verified date March 2023
Source Martin-Luther-Universität Halle-Wittenberg
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluation of practicability in survey and test procedures and of successful implementation of complex interventions - feasibility analysis based on a pilot study: Influence of conditional workout postpartum on arterial stiffness among women with status after preeclampsia, superimposed preeclampsia or HELLP-syndrome


Description:

Cardiovascular disease is the main cause of death among women in Europe and in the USA. Its costs amount annually more than 196 billions Euro in Europe. The federal state of Saxony-Anhalt occupies leading position in mortality in myocardial infarction and coronary heart disease in Germany. Up to 8 percent of all pregnant women develop a severe pregnancy-associated hypertension, like preeclampsia, superimposed preeclampsia or HELLP-syndrome. These women have an increased lifetime risk for cardio- and cerebrovascular diseases. The consecutive increasing arterial stiffness because of endothelial dysfunction is a determining factor in etiology of pregnancy-associated hypertension and results in increased cardiovascular risk. Aortal pulse wave velocity is used as Goldstandard for measuring arterial stiffness. Pregnant women suffering from a severe pregnancy-associated hypertension present higher levels in arterial stiffness measured by pulse wave velocity than healthy pregnant women. Pathological changes of the vascular systems persistent from 6 month until 10 years after delivery and give an explanatory approach for an increased cardiovascular longterm risk at these patients. Numerous medical associations like American Heart Association aim at reducing especially cardiovascular longterm risk in women with status after preeclampsia, superimposed preeclampsia or HELLP syndrome. Pregnancy-independent studies in patients with coronary heart disease and analysis in women with metabolic syndrome show a reduction of arterial stiffness by regular conditional workout. Scientific problem of this pilot study: If a reduction in arterial stiffness in women from a risk group - during a 6-month-ongoing intensive regular conditional workout within a midwife-supported teamwork and under inclusion of dietary interventions - achieved?


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 2021
Est. primary completion date April 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - diagnosis of preeclampsia, superimposed gestosis or HELLP syndrome - capacity for content Exclusion Criteria: - eclamptic stroke - New York Heart Association > Stadium II - severe neurological or orthopedic disabilities - peripheral arterial occlusive disease - severe disease of the newborn which leads to an intensive familial care

Study Design


Intervention

Behavioral:
conditional workout
6 month of regular conditional workout 1-3 times a weak

Locations

Country Name City State
Germany Maternity Clinic/Perinatal Treatment Center, Halle university hospital, Martin-Luther-Universität Halle-Wittenberg Halle (Saale) Sachsen Anhalt
Germany St. Elisabeth and St. Barbara Hospital / Women's clinic Halle (Saale) Saint

Sponsors (1)

Lead Sponsor Collaborator
Martin-Luther-Universität Halle-Wittenberg

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary reduced aortic pulse wave velocity by 1m/s six month
Secondary no arterial hypertension defined as blood pressure =140mmHg / 80mmHg without antihypertensic medication 13 years
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