PlacEntal Acute Atherosis RefLecting Subclinical Atherosclerosis

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Pregnancy is considered a cardiovascular (CV) stress test, and complicated pregnancies are associated with an increased risk for cardiovascular disease (CVD) later in life. Moreover, it is known that often the pregnancy induced CV adaptation does not resolve completely after a short postpartum (PP) period and it is not clear whether these induced changes will resolve over a longer period of time (i.e. in the upcoming months/years after delivery). Understanding the cardiac adaptation during pregnancy and the reversal process in the postpartum period, as well as the factors that influence this these processes, may provide us not only insight in this mechanism, but may help us in identifying factors that may be target points for modification.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
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• Women aged ≥ 18 years

• Controls: Women with an uncomplicated pregnancy at the moment of inclusion (i.e no foetal or maternal placental complications, such as pregnancy induced hypertension, preeclampsia or HELLP-syndrome, or small for gestational birth infancies)

• Cases: Women diagnosed with a preeclamptic pregnancy at the moment of inclusion

Locations
Other Locations
Netherlands
Maastricht University Medical Center (MUMC+)
RECRUITING
Maastricht
Contact Information
Primary
Gwyneth Jansen, MBBS
gwyneth.jansen@mumc.nl
043-38774145
Backup
Marc Spaanderman, MD, PhD
marc.spaanderman@mumc.nl
043-38774774
Time Frame
Start Date: 2016-11
Estimated Completion Date: 2028-12
Participants
Target number of participants: 226
Treatments
Short track controls
Controls are women (18 years or older) with an uncomplicated pregnancy (i.e no foetal or maternal placental complications, such as pregnancy induced hypertension, preeclampsia or HELLP-syndrome, or small for gestational birth infancies).~Follow up roughly 18 months postpartum.
Short track early PE with IUGR
These cases consist of women (18 years or older) with preeclampsia (PE) and/or HELLP syndrome in the current pregnancy (PE is defined as hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg) developed after 20 weeks of pregnancy with de novo proteinuria (≥ 300 mg/ 24 hours)) Cases will be subdivided into early and late PE, with or without IUGR (Early PE is defined as the occurence of PE \< 34 weeks of gestation, whereas late PE is defined as the occurence of PE ≥ 34 weeks of gestation. IUGR is defined as birthweight below the 10th percentile).~Follow up roughly 18 months postpartum.
Short track early PE without IUGR
Cases consist of women (18 years or older) with preeclampsia (PE) and/or HELLP syndrome in the current pregnancy (PE is defined as hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg) developed after 20 weeks of pregnancy with de novo proteinuria (≥ 300 mg/ 24 hours)) Cases will be subdivided into early and late PE, with or without IUGR (Early PE is defined as the occurence of PE \< 34 weeks of gestation, whereas late PE is defined as the occurence of PE ≥ 34 weeks of gestation. IUGR is defined as birthweight below the 10th percentile).~Follow up roughly 18 months postpartum.
Short track late PE with IUGR
Cases consist of women (18 years or older) with preeclampsia (PE) and/or HELLP syndrome in the current pregnancy (PE is defined as hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg) developed after 20 weeks of pregnancy with de novo proteinuria (≥ 300 mg/ 24 hours)) Cases will be subdivided into early and late PE, with or without IUGR (Early PE is defined as the occurence of PE \< 34 weeks of gestation, whereas late PE is defined as the occurence of PE ≥ 34 weeks of gestation. IUGR is defined as birthweight below the 10th percentile).~Follow up roughly 18 months postpartum.
Short track late PE without IUGR
Cases consist of women (18 years or older) with preeclampsia (PE) and/or HELLP syndrome in the current pregnancy (PE is defined as hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg) developed after 20 weeks of pregnancy with de novo proteinuria (≥ 300 mg/ 24 hours)) Cases will be subdivided into early and late PE, with or without IUGR (Early PE is defined as the occurence of PE \< 34 weeks of gestation, whereas late PE is defined as the occurence of PE ≥ 34 weeks of gestation. IUGR is defined as birthweight below the 10th percentile).~Follow up roughly 18 months postpartum.
Long term follow up track cases
Cases consist of women (18 years or older) with preeclampsia (PE) and/or HELLP syndrome in the current pregnancy (PE is defined as hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg) developed after 20 weeks of pregnancy with de novo proteinuria (≥ 300 mg/ 24 hours)) Cases will be subdivided into early and late PE, with or without IUGR (Early PE is defined as the occurence of PE \< 34 weeks of gestation, whereas late PE is defined as the occurence of PE ≥ 34 weeks of gestation. IUGR is defined as birthweight below the 10th percentile).~Follow up roughly 18 months postpartum.
Related Therapeutic Areas
Preeclampsia
Intrauterine Growth Restriction
Atherosclerosis
HELLP Syndrome
Sponsors
Leads: Maastricht University Medical Center

This content was sourced from clinicaltrials.gov

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