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Mindfulness & Mechanisms Study
NCT04626245 · View on ClinicalTrials.gov ↗
Study Summary
Hypertensive disorders of pregnancy (HDP) are the most common medical condition affecting pregnancy and a leading cause of maternal morbidity and mortality in the Unites States. HDP also increase lifetime cardiac disease risk in women and infants. Current interventions to prevent HDP are limited, and interventions that do not include medications are minimally effective at preventing HDP. Mindfulness interventions hold promise as a intervention to prevent HDP that does not require pregnant women to take medications. Past research shows that mindfulness interventions reduce blood pressure in adults with hypertension and pre-hypertension. However, past studies of mindfulness interventions for pregnant women have not allowed women at risk for HDP to participate. The preliminary study of prenatal mindfulness training for women at risk for HDP demonstrated benefit on maternal blood pressure and fetal growth. However, the mechanisms explaining effects of prenatal mindfulness training on risk for HDP are unknown. Building upon these promising preliminary findings, the proposed clinical trial will measure daily experiences of stress, physiological reactivity to stress, and interpersonal processes before and after prenatal mindfulness training. The investigators hypothesize that mindfulness training will impact these processes, which may lead to improved maternal cardiovascular parameters and reduced risk for HDP. N=150 pregnant women at risk for HDP will be randomized to an 8-week phone-delivered mindfulness intervention or usual care. For every participant, we will measure maternal cardiovascular parameters (24-hour blood pressure and uterine artery resistance values by ultrasound Doppler) before and after the 8-week period. All participants will complete surveys of daily experiences for 2 weeks before and after the 8-week period to evaluate mechanisms of mindfulness training on maternal cardiovascular parameters. Daily experiences will be measured using surveys delivered v
Conditions Studied
Interventions
- BEHAVIORAL Mindfulness training
Study Locations (1)
Rhode Island
- Women's Medicine Collaborative — Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2022-06-13 |
| Est. Completion | 2027-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04626245
The ClinicalTrials.gov registry entry for NCT04626245 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lifespan, which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Hypertension in Pregnancy appearing as the primary indexed condition, and to 1 intervention — of which Mindfulness training is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04626245 reports 1 study location spanning 1 distinct geographic area — top geographies include Rhode Island. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04626245 about?
NCT04626245 is a clinical study titled "Mindfulness & Mechanisms Study". Hypertensive disorders of pregnancy (HDP) are the most common medical condition affecting pregnancy and a leading cause of maternal morbidity and mortality in the Unites States. HDP also increase lifetime cardiac disease risk in women and infants. Current interventions to prevent HDP are limited, an...
What is the current status of trial NCT04626245?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2022-06-13. Estimated completion is 2027-06-30.
What conditions does trial NCT04626245 study?
This clinical trial studies the following conditions: Hypertension in Pregnancy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04626245?
The interventions under investigation include: Mindfulness training (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04626245?
This trial is sponsored by Lifespan, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04626245 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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