Mechanistic Underpinnings of Preeclampsia

NCT06567899 | Not Yet Recruiting

• 1 other identifier: STUDY00004565
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Preeclampsia is a dreadful disease with significant morbidity and mortality. Despite decades of research, we still need a proper diagnostic test or therapeutic option to treat this disorder. The proposed study will determine the diagnostic value of PBMC-secreted sFlt1 and determine the molecular mechanisms involved in its secretion. The molecular mechanisms can be novel therapeutic targets to treat this disorder.

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

• sFLT1 levels

  sFLT1 levels in preeclampsia should be higher than normal pregnancy.

  Outcome will be measured at 12 weeks, 24 weeks and 36 weeks of pregnancy.

Study Arms (6)

Non-pregnant with previous normal pregnancy

Non pregnant females

Non-pregnant with previous known preeclampsia

Women with known preeclampsia in previous pregnancy

First Trimester Pregnant (First antenatal visit)

Women in first trimester

Second Trimester Pregnant

Women in second trimester

Third Trimester with known preeclampsia

Women in third trimester with diagnosis of preeclampsia

Third Trimester with Normal Pregnancy

Women in third trimester with no complications.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant females and women with desire to get pregnant.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women above 18 years of age.

Healthy Adults: • Healthy non-pregnant with previous normal pregnant women Non-Health Adults: • Patients will be admitted with the diagnosis of preeclampsia according to the internationally accepted definition of preeclampsia: Blood pressure measurement of 140/90 mm Hg or an increase of 30 mm Hg systolic or 15 mm Hg diastolic over baseline values on at least two occasions, six or more hours apart and proteinuria; 300 mg/24 hour after 20th week of gestation. Pregnant Women: Groups 3 - 6 will include pregnant women at different trimesters. Criteria common to all groups: * The study will be conducted only in females aged 18 or above. * Patients in all the groups will be matched for age, which will be 18 or above. * Women will be matched for body mass index; criteria for normal body mass index will be used based on the Center for Disease Control and Prevention Guidelines. * Patients with premature rupture of the membrane, non-preeclamptic preterm labor, IUGR, placental abruption, twin? Any other complications during the pregnancy will be excluded from the study. * Patients with any evidence of genetic or non-genetic malformations of the fetus will be excluded from the study. * The study will be conducted on women who are non-smokers and do not consume alcohol or recreational drugs. * The study will be conducted only on primigravida females to minimize phenotyping variability. * The women with a known history of any chronic disorder, including but not limited to hypertension, diabetes, pulmonary, renal, cardiac, or cerebrovascular disorders, will be excluded from the studies.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Arizona: lead

Biospecimen

Retention: SAMPLES WITH DNA

Maternal blood, cord blood, and placenta will be collected.

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Ravi Goyal, MD, PhD

CONTACT

520-626-5573; goyalr@arizona.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: August 23, 2024
• Study Start (Estimated): July 25, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: November 26, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share