An observational study in Preeclampsia, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2018-05-02.
Sponsored by University of Pennsylvania · Observational
This study will evaluate the differences in cardiovascular parameters between women with severe preterm preeclampsia and those without preeclampsia using echocardiography and maternal blood. The investigators will also look at associations of abnormal cardiovascular findings and immediate complications among a high risk cohort of pregnant African American women.
This will be a prospective cohort study. Exposed cases will be admitted to the inpatient obstetrical unit (labor \& delivery or antepartum unit) at the Hospital of the University of Pennsylvania with concern for severe preterm preeclampsia. Unexposed controls will be matched by gestational age and other clinical factors and will be obtained from the outpatient setting (Helen O Dickens clinic or Penn ObGyn Associates at 3701 Market Street). The investigators will compare cardiovascular risk factors between these two groups.
882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.
This study's enrollment of 192 is above the median of 163 across 380 observational studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
This study will take place on the obstetrical unit at the Hospital of the University of Pennsylvania (HUP) as well as in the outpatient setting. The patient population is primary from the surrounding urban region. The majority receive prenatal care at our institution. Based on fiscal year 2010 at HUP, the mean age was 24 years old and 85% were African American.
Exposed cases:
Inclusion Criteria:
Exclusion Criteria:
Unexposed controls:
Inclusion Criteria:
Exclusion Criteria:
Non-African American women and women who are not receiving care at our institution.
African American women with concern for severe preterm (37 weeks gestation) preeclampsia who are admitted to the inpatient obstetrical unit at HUP.
African American women without preeclampsia or medical comorbidity who are matched by gestational age, maternal age, and BMI in the outpatient setting.
Cardiovascular parameters obtained on echocardiogram (longitudinal strain and E/E)
Time frame: 2 years
Angiogenic factors and biomarkers of congestive heart failure (sFlt1)
Time frame: 2 years
Other cardiovascular parameters measured on echocardiogram (ventricular arterial coupling, arterial tonometry)
Time frame: 2 years
Other angiogenic factors and biomarkers of CHF (VEGF, BNP, troponin, etc)
Time frame: 2 years
Postpartum readmission rate
Time frame: 2 years
Pulmonary edema during labor and delivery or postpartum
Time frame: 2 years
Peripartum cardiomyopathy
Time frame: 2 years
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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University of Pennsylvania