Mindfulness training to prevent hypertension in pregnancy
Mindfulness & Daily Experiences Study
This study is testing if mindfulness training can help pregnant women at risk for high blood pressure stay healthy without using medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | Lifespan Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT04626245 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of mindfulness training as a non-medication intervention to prevent hypertensive disorders of pregnancy (HDP). It targets women who are at moderate to high risk for HDP and aims to understand the mechanisms through which mindfulness may improve cardiovascular parameters. Participants will receive mindfulness training and their blood pressure and other health indicators will be monitored throughout the study. The approach is based on previous findings that mindfulness can reduce blood pressure in non-pregnant individuals and aims to extend these benefits to pregnant women.
Who should consider this trial
Good fit: Ideal candidates are English-speaking women with singleton pregnancies who are less than 20 weeks' gestation and have blood pressure below 140/90 but are at moderate to high risk for hypertensive disorders.
Not a fit: Patients with multiple gestations, severe depression, psychosis, or those currently engaged in regular mind-body practices may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of hypertension in pregnant women, improving maternal and fetal health outcomes.
How similar studies have performed: Previous studies have shown promise for mindfulness interventions in reducing blood pressure, but this specific application in pregnant women at risk for HDP is novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Providence, Rhode Island
- Women's Medicine Collaborative — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Principal investigator: Margaret H Bublitz — The Miriam Hospital
- Study coordinator: Margaret H Bublitz, PhD
- Email: margaret_bublitz@brown.edu
- Phone: 4017937884
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.