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Lifestyle Intervention for Preeclampsia (SAIL Trial)

N/A
Recruiting
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post intervention measured at the completion of the last study visit, 3 years
Awards & highlights

SAIL Trial Summary

This trial will test a lifestyle intervention to reduce the risk of preeclampsia, which is a disease of pregnancy that can lead to organ damage and death. The intervention incorporates social risk factors that may explain the racial and ethnic disparities in the disease.

Who is the study for?
This trial is for African-American/Non-Hispanic black women who are pregnant for the first time, less than 16 weeks along, living in inner-city Milwaukee, and can give informed consent. It's not open to those who don't speak English or have psychiatric illnesses that would prevent them from participating in group activities.Check my eligibility
What is being tested?
The SAIL program is being tested as a lifestyle intervention aimed at reducing the risk of preeclampsia by incorporating social risk factors into its strategy. The study focuses on addressing health disparities that contribute to higher risks of this condition among black women.See study design
What are the potential side effects?
Since SAIL is a lifestyle intervention rather than a drug treatment, it may not have typical medical side effects; however, participants might experience stress or discomfort due to changes in their daily habits or discussions about personal health issues.

SAIL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post intervention measured at the completion of the last study visit, 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and post intervention measured at the completion of the last study visit, 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Retention
Systolic and diastolic blood pressure: 6 Weeks Postpartum
Systolic and diastolic blood pressure: Post Intervention
Secondary outcome measures
Preeclampsia

SAIL Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SAIL interventionExperimental Treatment1 Intervention
6 monthly group sessions with the study nurse with a background in prenatal care and the PI that will include each group will include preeclampsia education, coaching on stress management, resource navigation, and training in problem solving.
Group II: Routine prenatal careActive Control1 Intervention
Routine prenatal care: All women participating in the study will receive routine prenatal care by their obstetric provider, consisting of 1 prenatal visit a month up to 28 weeks of gestation, 1 prenatal visit every 2 weeks during 28-36 weeks and weekly visits during 36-40 weeks.

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
608 Previous Clinical Trials
1,162,397 Total Patients Enrolled
American Heart AssociationOTHER
320 Previous Clinical Trials
4,932,388 Total Patients Enrolled

Media Library

SAIL Clinical Trial Eligibility Overview. Trial Name: NCT04958057 — N/A
Prophylaxis of Preeclampsia Research Study Groups: Routine prenatal care, SAIL intervention
Prophylaxis of Preeclampsia Clinical Trial 2023: SAIL Highlights & Side Effects. Trial Name: NCT04958057 — N/A
SAIL 2023 Treatment Timeline for Medical Study. Trial Name: NCT04958057 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

May those over the age of 45 participate in this medical experiment?

"The present clinical trial is open to those aged between 18 and 45. Those under the age of consent or over 65 are befitting for separate experiments, comprising 9 and 46 trials respectively."

Answered by AI

Is this trial presently accepting volunteers for participation?

"Affirmative. Clinicaltrials.gov confirms that this investigation into a medical intervention is actively recruiting participants, having been posted on March 28th 2022 and updated most recently on April 1st 2022. 100 persons are sought for the study which will take place at one site only."

Answered by AI

Who is eligible to join this research project?

"This medical trial is seeking to enrol approximately 100 participants, aged between 18 and 45 years old with pre-eclampsia."

Answered by AI

How many participants have been recruited for this research endeavor?

"Affirmative. Resources from clinicaltrials.gov suggest that, following its posting on March 28th 2022 and last update April 1st 2022, this study is actively seeking out 100 participants at one location."

Answered by AI
~11 spots leftby Jun 2024