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Search / Trial NCT04626245

Mindfulness & Mechanisms Study

Launched by LIFESPAN · Nov 10, 2020

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Mindfulness Pregnancy Blood Pressure Ecological Momentary Assessment

ClinConnect Summary

The Mindfulness & Mechanisms Study is a clinical trial aimed at exploring how mindfulness training might help prevent high blood pressure issues during pregnancy, known as hypertensive disorders of pregnancy (HDP). These conditions are common and can lead to serious health problems for both mothers and babies. The study will involve 150 pregnant women who are at moderate to high risk for developing HDP. To participate, women must be in their first 20 weeks of pregnancy, speak English, and have a blood pressure reading lower than 140/90. Women with multiple pregnancies or severe mental health issues, as well as those already practicing mindfulness regularly, will not be eligible.

Participants in this study will engage in an 8-week mindfulness program delivered over the phone, while some will continue with regular care. Throughout the study, researchers will measure participants' blood pressure and other heart health indicators before and after the mindfulness training. They will also gather information about daily stress experiences using surveys sent through a smartphone app and wearable devices that monitor heart rate. By examining how mindfulness affects stress and heart health, the researchers hope to better understand its potential benefits for pregnant women at risk for HDP.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Singleton pregnancy
  • English speaking
  • less than 20 weeks' gestation at enrollment
  • Blood pressure \< 140/90
  • Moderate to high risk for hypertensive disorders of pregnancy
  • Exclusion Criteria:
  • Multiple gestations
  • current severe depression or psychosis
  • ongoing mind-body practice (e.g., yoga, meditation, mindfulness =\> once a week).

About Lifespan

Lifespan is a leading healthcare organization dedicated to advancing medical research and improving patient outcomes through innovative clinical trials. With a commitment to excellence, Lifespan collaborates with a diverse network of healthcare professionals and institutions to conduct cutting-edge studies across various therapeutic areas. By leveraging state-of-the-art methodologies and a patient-centered approach, Lifespan aims to contribute to the development of groundbreaking treatments, ensuring the highest standards of safety and effectiveness. Their mission underscores a relentless pursuit of knowledge and a deep commitment to enhancing the quality of life for individuals and communities.

Locations

Providence, Rhode Island, United States

Patients applied

0 patients applied

Trial Officials

Margaret H Bublitz

Principal Investigator

The Miriam Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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