Recruiting

Observational Study

Sponsor:

University of Wisconsin, Madison

Code:

NCT03806283

Conditions

Pre-Eclampsia

Vascular Diseases

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Omental Biopsy

Study Details

Brief 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.

Conditions

Pre-Eclampsia

Vascular Diseases

Study ID

NCT03806283

Start date

Nov 20, 2018

Status verified date

Jan, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Female
  • Ages 18 to 40 years old
  • Singleton gestation between 28 weeks, 0 days and 41 weeks, 0 days gestational age at the time of consent
  • Undergoing caesarean section, either planned or otherwise with or without trial of labor

Exclusion Criteria:

  • 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
  • Undergoing cesarean section for placental abruption or bleeding complications.
  • Singleton gestation not within 36 weeks, 0 days and 41 weeks, 0 days gestational age at the time of enrollment (delivery)

Study Design

Enrollment

166 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1 no Preeclampsia

Cohort 1: mothers with no diagnosis of preeclampsia during pregnancy Omental Biopsy and placental collection will be performed

Cohort 2 mild or severe Preeclampsia

Cohort 2: mothers with diagnosis of mild or severe preeclampsia during pregnancy Omental Biopsy and placental collection will be performed

Interventions

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.

Primary outcome measure

  • Quantify the vascular AT2R expression and vascular function in placental and omental vascular arteries in both preeclamptic and controlled pregnancies. [ Time Frame: 1 year ]
  • To test if ex-vivo treatment of AT2R agonists reverses the endothelial dysfunction and improves vasoconstriction in the preeclamptic vessels. [ Time Frame: 1 year ]
  • To test AT2R mediated mechanisms on endothelial derived hyperpolarizing factor, nitric oxide and prostacyclin pathway of vascular relaxation to examine AT2's role in vaso-relaxation and AT2R mediated vasoconstrictor pathway will be defined. [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

UW Ob/Gyn Human Subjects Core

608-890-3345research.crc_obgyn@wisc.edu

Locations

UnityPoint Health-Meriter Hospital

Recruiting

Madison, Wisconsin, United States, 53715

Principal Investigator:

Sathish Kumar, PhD

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-01-20.