PreeclampsiaSAILNCT04958057
Social Risks-Focused Lifestyle Intervention to Reduce Preeclampsia (SAIL)
A study testing SAIL in people with Preeclampsia, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia
- What is being tested?
- SAIL
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- not able to communicate in English
- major fetal anomaly
- psychiatric illness that precludes group participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Wauwatosa, Wisconsin, 53226
About this study
Official title: Social Risks-Focused Lifestyle Intervention to Reduce Preeclampsia in AA Women
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.
Read the detailed description
Preeclampsia is a significant global health problem affecting over 10 million pregnancies each year. Preeclampsia disproportionately burdens ethnic minority women, especially African American women when compared to non-Hispanic white women. Once diagnosed with preeclampsia, African women are 3 times more likely to die of preeclampsia compared to their white counterparts. Evidence supports contribution of social risk factors towards racial and ethnic disparities seen with preeclampsia. However, currently, there are few trials that examine efficacy of social risks-focused lifestyle interventions on reduction of preeclampsia and its complications. This proposal is designed to address this crucial gap by testing feasibility (Aim 1), acceptability (Aim 1) and efficacy (Aim 2) of a social risks-focused lifestyle intervention to reduce preeclampsia in pregnant inner-city African American women. The intervention will be delivered via a randomized control trial design (N=100), with 6 monthly group sessions conducted in the second and third trimesters. The overall hypothesis is that the intervention will be feasible and acceptable, and that women randomized to the intervention group will have lower blood pressure and lower rates of preeclampsia compared with women receiving routine prenatal care.
- Conditions
- Preeclampsia
- Being tested
- SAIL
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAILBehavioural
Also called SociAl rIsks-focused Lifestyle 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.
| Study group | Role | What they receive |
|---|---|---|
| Routine prenatal care | No 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. |
| SAIL intervention | Experimental | 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. Receives: Behavioral: SAIL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Retention will be measured by session attendance rates.
Measured: Post intervention measured at the completion of the last study visit, 3 years
Systolic and diastolic blood pressure: Post Intervention
BP will be taken by a study trained and certified research assistant using the study OMRON automated device.
Measured: Post intervention/at the last study visit, up to 40 weeks
Systolic and diastolic blood pressure: 6 Weeks Postpartum
BP will be taken by a study trained and certified research assistant using the study OMRON automated device.
Measured: At 6 weeks postpartum visit
Secondary outcomes (1)
Preeclampsia
The rate of preeclampsia diagnosis will be compared between intervention and control group.
Measured: At the 6 weeks postpartum visit through patient interview, confirmed with medical record review
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start28 Mar 2022
- Primary completion30 Nov 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group prenatal care with a focus on preeclampsia prevention
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Anna Palatnik, MD, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958057
- Sponsor's protocol ID
- PRO00041206
- Other IDs
- 847482
- Acronym
- SAIL
- Status last verified
- Aug 2025
- First submitted
- 28 Jun 2021
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The proposed study will be conducted, and the data analyzed, and results disseminated in an objective and transparent manner. All investigators are aware of and agree to abide by the principles for sharing research resources, as described by NIH in "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Programs."
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Risks-Focused Lifestyle Intervention to Reduce Preeclampsia in AA Women
- ClinicalTrials.gov ID
- NCT04958057
- Acronym / sponsor ID
- SAIL / PRO00041206
- Conditions
- Preeclampsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Preeclampsia is a significant global health problem affecting over 10 million pregnancies each year. Preeclampsia disproportionately burdens ethnic minority women, especially African American women when compared to non-Hispanic white women. Once diagnosed with preeclampsia, African women are 3 times more likely to die of preeclampsia compared to their white counterparts. Evidence supports contribution of social risk factors towards racial and ethnic disparities seen with preeclampsia. However, currently, there are few trials that examine efficacy of social risks-focused lifestyle interventions on reduction of preeclampsia and its complications. This proposal is designed to address this crucial gap by testing feasibility (Aim 1), acceptability (Aim 1) and efficacy (Aim 2) of a social risks-focused lifestyle intervention to reduce preeclampsia in pregnant inner-city African American women. The intervention will be delivered via a randomized control trial design (N=100), with 6 monthly group sessions conducted in the second and third trimesters. The overall hypothesis is that the intervention will be feasible and acceptable, and that women randomized to the intervention group will have lower blood pressure and lower rates of preeclampsia compared with women receiving routine prenatal care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group prenatal care with a focus on preeclampsia prevention
| Arm | Type | Receives |
|---|---|---|
| Routine prenatal care | No 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. |
| SAIL intervention | Experimental | Behavioral: SAIL6 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- not able to communicate in English
- major fetal anomaly
- psychiatric illness that precludes group participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAILAlso: SociAl rIsks-focused Lifestyle intervention6 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. | Behavioural | SAIL intervention |
Primary outcome
Retention
Time frame: Post intervention measured at the completion of the last study visit, 3 years
Retention will be measured by session attendance rates.
Systolic and diastolic blood pressure: Post Intervention
Time frame: Post intervention/at the last study visit, up to 40 weeks
BP will be taken by a study trained and certified research assistant using the study OMRON automated device.
Systolic and diastolic blood pressure: 6 Weeks Postpartum
Time frame: At 6 weeks postpartum visit
BP will be taken by a study trained and certified research assistant using the study OMRON automated device.
1 secondary outcome
Preeclampsia
Time frame: At the 6 weeks postpartum visit through patient interview, confirmed with medical record review
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: No. The proposed study will be conducted, and the data analyzed, and results disseminated in an objective and transparent manner. All investigators are aware of and agree to abide by the principles for sharing research resources, as described by NIH in "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Programs."
Related trials for Preeclampsia
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Preeclampsia
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAIL in people with Preeclampsia, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention (time frame: Post intervention measured at the completion of the last study visit, 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.