Mechanistic Underpinnings of Preeclampsia | NCT06567899

Studies
Mechanistic Underpinnings of Preeclampsia

NCT06567899

Sponsor

University of Arizona

Status

Not yet recruiting

Last Update Posted

Nov 26, 2025Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Preeclampsia

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 25, 2026Estimated

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2029Estimated

First Submitted Date

May 29, 2024

First Submission Date that Met QC Criteria

Aug 19, 2024

First Posted Date

Aug 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2025

Last Update Posted Date

Nov 26, 2025Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnant females and women with desire to get pregnant.

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Women above 18 years of age.

Sampling Method

Probability Sample

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases