Lifestyle Intervention for Preeclampsia

(SAIL Trial)

Overseen By Eleanor Saffian, RN

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Non-English, Major fetal anomaly, Psychiatric illness

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new lifestyle intervention called SAIL, designed to reduce the risk of preeclampsia, a pregnancy condition marked by high blood pressure and potential organ damage. The study will test whether incorporating social factors into prenatal care can make a difference. Participants will either receive routine prenatal care or engage in group sessions focusing on education, stress management, and problem-solving. The trial seeks African-American/Non-Hispanic Black women who are pregnant for the first time, live in inner-city Milwaukee, and are less than 16 weeks pregnant. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve prenatal care for future generations.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this lifestyle intervention is safe for pregnant women?

Research shows that lifestyle programs like the SAIL program under study are generally safe and manageable. SAIL emphasizes teaching, stress management, and problem-solving, which are typically low-risk activities. Although specific safety data for SAIL is not yet available, similar programs focusing on social and behavioral changes usually report few side effects.

This trial phase does not typically focus on safety, indicating that the treatment is likely safe enough for more extensive testing. Participants in the SAIL program will also receive guidance from healthcare professionals, adding an extra layer of safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SAIL intervention for preeclampsia because it takes a holistic approach by focusing on lifestyle changes rather than medication. Unlike standard treatments that often involve blood pressure management and medication to control symptoms, SAIL provides education on preeclampsia, stress management coaching, and problem-solving training. This method empowers expectant mothers to take an active role in managing their health, potentially reducing stress and improving outcomes without relying solely on drugs.

What evidence suggests that the SAIL intervention could be effective for preeclampsia?

Research has shown that lifestyle changes, such as managing stress and exercising, can significantly lower the risk of preeclampsia, a serious condition during pregnancy. One study found that regular exercise reduced the risk of high blood pressure during pregnancy by about 30% and preeclampsia by 40%. Improving lifestyle habits could therefore help manage or lower the risk of preeclampsia. In this trial, participants in the SAIL intervention arm will receive education and coaching on stress management to address these risk factors. Although more research is needed to fully confirm its effectiveness, early results are promising. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

gestational age at enrollment <=16 weeks

You have never been pregnant.

able and willing to give informed consent

Exclusion Criteria

You have a mental illness that makes it difficult for you to participate in group activities.

The unborn baby has a severe abnormality.

I cannot communicate in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a social risks-focused lifestyle intervention with 6 monthly group sessions during the second and third trimesters

6 months

6 group sessions (in-person)

Routine Prenatal Care

Participants receive routine prenatal care with varying visit frequency based on gestational age

Up to 40 weeks

1 visit/month up to 28 weeks, 1 visit/2 weeks during 28-36 weeks, weekly visits during 36-40 weeks

Follow-up

Participants are monitored for preeclampsia and blood pressure at 6 weeks postpartum

6 weeks postpartum

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• SAIL

Trial Overview 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.

How Is the Trial Designed?

Group I: SAIL intervention Experimental Treatment 1 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 care Active Control 1 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.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/HYP.0000000000000208

Hypertension in Pregnancy: Diagnosis, Blood Pressure ... Exercise may reduce gestational hypertension and preeclampsia risk by ≈30 and 40%, respectively.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9031058/

Hypertension in Pregnancy: Diagnosis, Blood Pressure Goals ... Low dose aspirin, starting between 12 and 16 weeks of gestation, reduces the risk of preeclampsia and related adverse outcomes by 10 to 20% in women at ...

3. go.drugbank.com go.drugbank.com/conditions/DBCOND0000606

Pre-Eclampsia (DBCOND0000606) Associated Data ; NCT03961360. Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida. Acetylsalicylic acid.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11543432/

Effect of low-dose aspirin intervention on pre-eclampsia ... Low-dose aspirin demonstrates promising efficacy as an intervention strategy for high-risk preeclamptic women. It does not increase the risk of postpartum ...

5. uspreventiveservicestaskforce.org uspreventiveservicestaskforce.org/home/getfilebytoken/YC7EPeMLhj5d-n_6cGAwp4

Screening for Hypertensive Disorders of Pregnancy The proportion of participants developing hypertension during pregnancy was approximately the same in the intervention group (15.3%) and the control group. ( ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK595100/?report=reader

Screening for Hypertensive Disorders of Pregnancy: An ... One possible intervention would be to increase clinician awareness of groups with elevated risk of hypertensive disorders of pregnancy and adverse outcomes, ...

7. peearz.com peearz.com/trialsindex?nctid=NCT04958057

Social Risks-Focused Lifestyle Intervention to Reduce ... 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 ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39209299/

Impact of Patient Safety Bundle and Team-Based Training ... Hypertensive emergency treatment improved with patient safety bundle.. · Training and order sets improved adherence to hypertensive ...

9. saildatabank.com saildatabank.com/sail-databank-offers-a-vital-research-tool-for-medicine-safety-during-breastfeeding/

SAIL Databank offers a vital research tool for medicine ... This study highlights the rich, individual-level data for the population of Wales that is available anonymously within SAIL Databank that could ...