Mindfulness + Wearable Biosensors for Pre-eclampsia

(MINDBP Trial)

Not yet recruiting at 1 trial location

Overseen By Anna Palatnik, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Must be taking: Low-dose aspirin

Disqualifiers: Multiple gestation, Chronic hypertension, others

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

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how mindfulness training and wearable biosensors can assist pregnant women at risk for pre-eclampsia, a condition that can lead to high blood pressure and other complications. Participants will receive either mindfulness training with biosensors, mindfulness training alone, or routine prenatal care. The researchers aim to determine if these interventions are feasible and potentially beneficial. This trial suits pregnant women who are less than 16 weeks along, have a single baby without anomalies, and are at moderate to high risk for pre-eclampsia, but are not currently experiencing high blood pressure. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance prenatal care for future mothers.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mindfulness training is safe for pregnant women. One study found that mindfulness breathing exercises improved the health of pregnant women with pre-eclampsia without any safety issues. Another study demonstrated that mindfulness training can reduce stress levels in pregnant women, further supporting its safety.

Regarding mindfulness with wearable devices, studies have shown this method is safe and acceptable for adults. One study found that using a brain-sensing device for meditation during work hours was both safe and well-received. Although this study focused on non-pregnant adults, it suggests that combining mindfulness with technology should be safe.

In summary, both mindfulness training and its use with wearable devices have been well-tolerated, with no serious side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about integrating mindfulness with wearable biosensors for managing pre-eclampsia because it offers a non-invasive and holistic approach. Unlike traditional treatments that often rely on medication to manage symptoms, mindfulness training focuses on mental well-being, potentially reducing stress-related impacts on blood pressure. The addition of wearable biosensors allows for real-time self-monitoring, giving expectant mothers more control and insight into their health, which could lead to earlier detection and intervention. This combination of mental training and technology could offer a more personalized and empowering way to manage pre-eclampsia.

What evidence suggests that this trial's treatments could be effective for pre-eclampsia?

Research has shown that mindfulness training (MT) can help lower blood pressure. One study found that MT reduced the systolic blood pressure by about 5 points in people with hypertension. For pregnant women, MT has reduced stress and improved mental health. In this trial, some participants will receive MT alone, while others will receive MT combined with self-monitoring using data from wearable biosensors. When combined with feedback from wearable devices, MT might better manage stress and anxiety. These findings suggest MT could benefit pregnant women at risk of pre-eclampsia, a condition related to high blood pressure. ^{2 3 4 6 7}

Who Is on the Research Team?

Anna Palatnik, MD

Principal Investigator

Medical College of Wisconsin

Margaret Bublitz, PhD

Principal Investigator

Brown University

Are You a Good Fit for This Trial?

This trial is for pregnant women at risk of developing hypertensive disorders like pre-eclampsia. Participants will be randomly assigned to one of three groups: mindfulness training with a wearable biosensor, mindfulness training alone, or routine prenatal care.

Inclusion Criteria

Live, non-anomalous gestation

Meet criteria consistent with 'moderate' to 'high' risk for preeclampsia based on ACOG/USPSTF guidelines for low-dose aspirin administration to prevent hypertensive disorders of pregnancy

My blood pressure is normal.

Exclusion Criteria

Multiple gestation

Chronic (pregestational hypertension)

Inability of unwillingness to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Mindfulness Training

Participants receive 8 weekly phone-based mindfulness training sessions

8 weeks

8 visits (virtual)

Booster Sessions

Participants receive two booster sessions at 1 and 2 months post-intervention

2 months

2 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness Training

Trial Overview The study is testing if mindfulness training (MT), when combined with monitoring using a Garmin Vivoactive 4 watch, can help prevent hypertensive disorders during pregnancy compared to MT alone or standard care.

How Is the Trial Designed?

Group I: MT + Biofeedback Experimental Treatment 2 Interventions

Mindfulness training plus self-monitoring with access to data from wearable biosensor

Group II: MT Experimental Treatment 1 Intervention

Mindfulness training (no access to wearable biosensor data)

Group III: Control Active Control 1 Intervention

Routine prenatal care alone

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10288303/

Feasibility, acceptability, and preliminary effects of ... Mindfulness training (MT) significantly reduces blood pressure in non-pregnant adults, yet MT has not been tested to reduce blood pressure in the prenatal ...

2. journals.lww.com journals.lww.com/jhypertension/fulltext/2025/05002/mindfulness_therapy_for_preeclampsia__a_systematic.41.aspx

Mindfulness Therapy for Preeclampsia: A Systematic ... Mindfulness training and music therapy also reduced systolic blood pressure by -5.00 mmHg and -4.75 mmHg, respectively. Yoga further improved neonatal outcomes, ...

3. trial.medpath.com trial.medpath.com/clinical-trial/c81eecbd23d73971/nct06841367-stress-reduction-training-preeclampsia-pregnancy

The Effect of Awareness-Based Stress Reduction Training on ... Mindfulness-based training for the psychological health of pregnant women has been reported to significantly reduce perceived stress and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10412792/

The Effect of Body Relaxation Techniques on Pre ... Consistent with the results of Awad et al.,[19] in our study, stretching exercises and relaxation significantly decreased the systolic and diastolic blood ...

5. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2023.1073494/full

Effectiveness of mindfulness training on pregnancy stress ... Mindfulness-based interventions effectively reduced the level of pregnancy stress and adjusted the HPA axis function in pregnant women in China.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12046138/

Mindfulness-Based Breathing Exercise on Health Profile ... Mindfulness-based breathing exercise can be safely used as a care intervention to improve the health profile of pregnant women with pre-eclampsia.

7. pediatrics.jmir.org pediatrics.jmir.org/2023/1/e53933/

Evaluating the Impact of an App-Delivered Mindfulness ... This study found evidence to support the Headspace app as an effective intervention to aid in stress and anxiety reduction during pregnancy.