NCT06640842

Brief Summary

The purpose of this study is to learn if hypertensive disorders during pregnancy affects brain health in midlife.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2024

Completed
25 days until next milestone

Study Start

First participant enrolled

September 23, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2025

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

9 months

First QC Date

August 29, 2024

Last Update Submit

June 26, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Cardiometabolic markers of middle age women

    Assess cardiometabolic marker values differences between the women diagnosed with a hypertensive disorder of pregnancy to the values of the healthy control.

    Baseline

  • Neurovascular hemodynamics of middle age women

    Assess differences in heart rate via an ECG, and beat to beat blood pressure, cerebral blood flow, and pulse wave velocity) between the women diagnosed with hypertensive disorder of pregnancy to the values of the healthy control.

    Baseline

  • Brain structure & function of middle age women

    Assess differences in MRI MPRAGE, fMRI and DTI sequencing scan between the women diagnosed with hypertensive disorder of pregnancy to the values of the healthy control.

    Baseline

  • Alzheimer's disease-related plasma biomarkers of middle age women

    Assess value differences in a predetermined Alzheimer's disease-related plasma biomarkers between the women diagnosed with hypertensive disorder of pregnancy to the values of the healthy controls.

    Baseline

Study Arms (2)

Hypertensive disorder of pregnancy

Women who were diagnosed with a hypertensive disorder of pregnancy during the ADORE study participation.

Diagnostic Test: A combination of various test and biomarkers will be completed to understand the effect of hypertensive disorders of pregnancy in brain health in midlife.

Healthy pregnancy

Women who participated in the ADORE study and had a healthy pregnancy during their participation.

Diagnostic Test: A combination of various test and biomarkers will be completed to understand the effect of hypertensive disorders of pregnancy in brain health in midlife.

Interventions

Participants will be asked to complete a blood draw, 5-lead ECG, MRI, a series of cognitive assessments, dietary assessments, monitor sleep and physical activity and DXA scan.

Healthy pregnancyHypertensive disorder of pregnancy

Eligibility Criteria

Age18 Years - 54 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women who previously participated in the ADORE, received a hypertensive disorder diagnosis or had a healthy pregnancy during their participation.

You may qualify if:

  • Participated in the ADORE trial ( R01 HD083292)

You may not qualify if:

  • History of seizures or Epilepsy
  • Pregnant at screening
  • Ineligible to complete MRI due to metal in the body

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Hypertension, Pregnancy-InducedAlzheimer DiseaseDementiaCardiovascular DiseasesPre-Eclampsia

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Holly R Hull, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2024

First Posted

October 15, 2024

Study Start

September 23, 2024

Primary Completion

June 13, 2025

Study Completion

June 13, 2025

Last Updated

June 29, 2025

Record last verified: 2025-06

Locations