Influence of Conditional Workout Postpartum on Arterial Stiffness Among Women With Status After Preeclampsia, Superimposed Preeclampsia or HELLP-syndrome

Preeclampsia Clinical Trial

— RedCarRisk  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02754778
• Other study ID #: RedCarRisk-Study
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• HELLP Syndrome
• Pre-Eclampsia
• Preeclampsia
• Superimposed Preeclampsia
• Syndrome

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

External Links

•   Paper