Angiotensin 2 Receptor (AT2R) in Endothelial Cells in Preeclampsia
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pre Eclampsia
- Vascular Diseases
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 35 years
- Gender
- Only males
Description
Trial Design: The study is a comparison of two cohorts, those with and without preeclampsia during pregnancy. The study team plans to investigate role of AT2 in modulation of vascular function/dysfunction using vessels isolated from the omental biopsies by examining for the evidence of fetal vascula...
Trial Design: The study is a comparison of two cohorts, those with and without preeclampsia during pregnancy. The study team plans to investigate role of AT2 in modulation of vascular function/dysfunction using vessels isolated from the omental biopsies by examining for the evidence of fetal vascular dysfunction mediated by decreased expression of AT2 in preeclampsia using vessels isolated from the placentas. Study Population: The study will include pregnant women. The pregnant women will participate in the omental tissue collection, placenta collection, and the medical record review. The study is expects a maximum enrollment of 70 pregnant women. This is because 32 omental biopsies and 32 placentas are required to meet proposed statistical considerations. Subjects have the option of providing just one or both of the specimens. There is a possibility as few as 32 subjects could be enrolled and a maximum of 64 subjects could be enrolled to meet this requirement. There is an additional 6 subjects enrollment built into the enrollment number to allow for replacement of subjects based on lack of clinical data in some subjects, failure of tissue viability and hence experiments. This required enrollment (32) is divided into two cohorts based on the diagnosis of preeclampsia: 16 of each type of specimen in which the woman was diagnosed with preeclampsia during her pregnancy, and 16 of each type of specimen in which the woman was not diagnosed with preeclampsia during her pregnancy. Additionally, each cohort of 16 will be divided into two groups based on gender of the fetus, 8 male fetuses and 8 female fetuses
Tracking Information
- NCT #
- NCT03806283
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Principal Investigator: Dinesh Shah, MD University of Wisconsin, Madison
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