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Mechanistic Underpinnings of Preeclampsia (MUP)

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University of Arizona

Status

Begins enrollment in 5 months

Conditions

Preeclampsia

Study type

Observational

Funder types

Other

Identifiers

NCT06567899
STUDY00004565

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

500 participants in 6 patient groups

Non-pregnant with previous normal pregnancy
Description:
Non pregnant females
Non-pregnant with previous known preeclampsia
Description:
Women with known preeclampsia in previous pregnancy
First Trimester Pregnant (First antenatal visit)
Description:
Women in first trimester
Second Trimester Pregnant
Description:
Women in second trimester
Third Trimester with known preeclampsia
Description:
Women in third trimester with diagnosis of preeclampsia
Third Trimester with Normal Pregnancy
Description:
Women in third trimester with no complications.

Trial contacts and locations

0

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Central trial contact

Ravi Goyal, MD, PhD

Data sourced from clinicaltrials.gov

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