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NCT04626245 · ClinicalTrials.gov registry record · NA
Mindfulness & Mechanisms Study
A NA study of Hypertension in Pregnancy, sponsored by Lifespan.
- Active
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT04626245 is a NA study of Hypertension in Pregnancy that is active but no longer recruiting, run by Lifespan. The registered enrollment target is 150 participants, below the 437-participant average among 13 other Hypertension in Pregnancy trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04626245, a NA study of Hypertension in Pregnancy, is active but no longer recruiting, sponsored by Lifespan.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 437-participant average among 13 other Hypertension in Pregnancy trials with a reported enrollment target (66% lower). The listed sponsor is Lifespan, which has 18 total studies on file at ClinicalTrials.gov.
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.
NCT04626245 reports 1 study location spanning 1 distinct geographic area - top geographies include Rhode Island.
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.
What interventions are being tested in trial NCT04626245?
The interventions under investigation include: Mindfulness training (BEHAVIORAL).
Who is sponsoring clinical trial NCT04626245?
This trial is sponsored by Lifespan, which has 18 total clinical trials registered on ClinicalTrials.gov.
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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Related
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