Angiotensin 2 Receptor (AT2R) in Endothelial Cells in Preeclampsia

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

Inclusion Criteria:

- female

- Minimum age: 18

- Maximum age: 35

- Singleton births

- Minimum gestational age at consent: 28 weeks, 0 days

- Maximum gestational age at consent: 41 weeks, 0 days

- Undergoing caesarean section, either planned or otherwise with or without trial of
labor

Exclusion Criteria:

- Preexisting hypertension treated by antihypertensive agents during the prenatal
period. This will not include treatment of severe hypertension by antihypertensive or
use of magnesium sulfate after the patient is hospitalized for the diagnosis of
preeclampsia.

- Any major fetal structural anomalies or aneuploidies

- Preexisting conditions like pre-gestational type I or type II diabetes mellitus,
pre-pregnancy kidney disease with increased serum creatinine above 1.2 mg/dL, or other
underlying blood vessel problems like systemic lupus erythematosus or other autoimmune
conditions with evidence of pre-pregnancy proteinuria or hypertension.

- Undergoing cesarean section for placental abruption or bleeding complications.

- Treatment with betamethasone before 36 weeks and 0 days gestation

- Singleton gestation not within 36 weeks, 0 days and 41 weeks, 0 days gestational age
at the time of enrollment (delivery)