NCT03806283

Mechanisms of Pregnancy Vascular Adaptations

Angiotensin 2 Receptor (AT2R) Expression/Activation in Endothelial Cells in Preeclampsia

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 166 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The investigators will collect omental tissue (research surgical excision) and placental tissue (standard of care clinical delivery) from both preeclamptic and non-preeclamptic women during their c-section and use these samples to study the blood vessels, specifically the expression/activation of the AT2R.

Detailed description

Trial Design: The study is a comparison of two cohorts, those with and without preeclampsia during pregnancy. The team plans to investigate role of FABP4, PFAS and AT2 in modulation of vascular function/dysfunction using vessels isolated from the omental biopsies. The investigators will examine 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 166 pregnant women. This is because 52 omental biopsies and 104 placentas are required to meet proposed statistical considerations. Participants have the option of providing just one or both of the specimens. There is a possibility as few as 52 participants could be enrolled and a maximum of 166 participants could be enrolled to meet this requirement. There is an additional 10 participants enrollment built into the enrollment number to allow for replacement of subjects based on lack of clinical data in some participants, failure of tissue viability and hence experiments, and thus a maximum of 166 (156+10) participants could be enrolled. This required enrollment is divided into two cohorts based on the diagnosis of preeclampsia: specimens in which the woman was diagnosed with preeclampsia during her pregnancy, and 26 of each type of specimen in which the woman was not diagnosed with preeclampsia during her pregnancy. Additionally, each cohort will be divided into two groups based on gender of the fetus.

Conditions

• Pre-Eclampsia
• Vascular Diseases

Interventions

Type	Name	Description
PROCEDURE	Omental Biopsy	The surgeon and clinical care team will conduct the c-section to deliver the baby and the placenta as clinically indicated. After delivery, during the closing procedures, the surgeon will indicate a time for a participating Ob/Gyn physician on the study team to collect the omental bio-specimen. Omentum is frequently excised or removed for clinical reasons during surgical procedures. Omentum has small blood vessels within it that have been used for evaluation of vascular functional changes in research. The investigators wish to isolate one to three vessels of 5 to 7 cm length. The surgeon will then close and the clinical care team will resume their standard of care activities.

Timeline

• Start date: 2018-11-20
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2019-01-16
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States