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NCT04958057Completed

Social Risks-Focused Lifestyle Intervention to Reduce Preeclampsia (SAIL)

Social Risks-Focused Lifestyle Intervention to Reduce Preeclampsia in AA Women

Source: ClinicalTrials.gov · Last updated 7 Aug 2025

Brief summary (registry, in English)

Preeclampsia is a disease of pregnancy and first few weeks after birth. It is diagnosed as new onset of high blood pressure and injury to organs such as kidneys, liver, and brain. Preeclampsia is growing at a rapid rate - rate that exceeds diabetes and heart disease. Over half a million lives lost each year to preeclampsia. Women with a history of preeclampsia have 3-4 times the risk of high blood pressure. They also have double the risk for heart disease and stroke. Racial and ethnic disparities are present in preeclampsia. Black women are at higher risk of developing preeclampsia. They are also at much higher risk of dying from preeclampsia than other women. The reasons behind such disparities are unclear. What may explain these differences are social determinants of health. The contribution of social determinants to differences in preeclampsia is well recognized. However, a major gap in research remains strategies that address these factors. Our study will test a lifestyle intervention incorporating social risk factors to reduce the risk of preeclampsia.

Status (registry)
Completed
Study type
Interventional
Enrollment
100 (actual)
First submitted
28 Jun 2021
Start date
28 Mar 2022
Primary completion date
30 Nov 2024
Lead sponsor
Medical College of Wisconsin
NCT number
NCT04958057

What you commit to

  • Study type: Interventional
  • Participants enrolled: 100
  • From 28 Mar 2022 to the primary completion date, 30 Nov 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • psychiatric illness that precludes group participation

Other

  • not able to communicate in English
  • major fetal anomaly

Who the study is looking for

  • self-report as African-American/Non-Hispanic black
  • residence in inner-city Milwaukee
  • nulliparity
  • gestational age at enrollment \<=16 weeks
  • able and willing to give informed consent

Age in the registry: 18 years to 45 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical College of Wisconsin
Coordinator of this site? Confirm its status
WauwatosaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.