Status:
RECRUITING
Mechanisms of Pregnancy Vascular Adaptations
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Pre-Eclampsia
Vascular Diseases
Eligibility:
FEMALE
18-40 years
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-se...
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 functi...
Eligibility Criteria
Inclusion
- female
- Minimum age: 18
- Maximum age: 40
- 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
- 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.
- Singleton gestation not within 36 weeks, 0 days and 41 weeks, 0 days gestational age at the time of enrollment (delivery)
Key Trial Info
Start Date :
November 20 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT03806283
Start Date
November 20 2018
End Date
April 1 2027
Last Update
August 22 2025
Active Locations (1)
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1
UnityPoint Health-Meriter Hospital
Madison, Wisconsin, United States, 53715