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Hypertension in PregnancyNCT04626245

Mindfulness & Mechanisms Study

A study testing Mindfulness training in people with Hypertension in Pregnancy, run by Lifespan at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years, women only
Conditions the study is for
Hypertension in Pregnancy
What is being tested?
Mindfulness training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteUnited States
Study dates
13 Jun 2022to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Singleton pregnancy
  • English speaking
  • less than 20 weeks' gestation at enrollment
  • Blood pressure < 140/90
  • Moderate to high risk for hypertensive disorders of pregnancy

Who cannot join

  • Multiple gestations
  • current severe depression or psychosis
  • ongoing mind-body practice (e.g., yoga, meditation, mindfulness => once a week).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Women's Medicine Collaborative

    Providence, Rhode Island, 02906

Other trials in United States

About this study

Official title: Mindfulness & Daily Experiences 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, 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 via smartphone-app, ambient audio sampling, and wearable wrist-worn biosensor monitoring (heart rate and heart rate variability).

Read the detailed description

Hypertensive disorders of pregnancy (HDP) are the most common medical conditions in pregnancy and a leading cause of maternal morbidity and mortality in the United States. HDP are also associated with significant financial costs to the US healthcare system; $2.18 billion is spent on treatment of affected mothers and infants in the first year after delivery. Women exposed to HDP are at increased lifetime risk for cardiovascular disease, dementia, and all-cause mortality. Current interventions to prevent HDP are limited and do not target underlying mechanisms of disease. Mindfulness training (MT) holds tremendous promise as a mind-body intervention to prevent HDP. MT is effective at reducing blood pressure in non-pregnant patients with pre-hypertension and hypertension and has proven more effective at blood pressure reduction than other stress management interventions. Results from the pilot RCT were the first to indicate that prenatal phone-delivered MT is feasible and had a medium to large effect on cardiovascular parameters in women at risk for HDP. However, the mechanisms through which prenatal MT affects cardiovascular parameters are not yet understood.

MT teaches participants to "attend and respond in a non-judgmental way to ordinary, everyday experiences." Theory and available evidence indicate that MT elicits relaxation, decreases stress biomarkers and autonomic activation, and decreases loneliness --- dynamic processes that may serve as pathways to improved cardiovascular parameters in women at risk for HDP. The proposed RCT will harness subjective and objective ecological momentary assessment (EMA) methodologies (in vivo repeated assessments) in combination with wearable biosensor technology to capture rich epochs of ecologically-valid psychological, physiological, and interpersonal processes through which MT may lead to improved maternal cardiovascular parameters. Pregnant women at risk for HDP will be randomized to an 8-week phone-delivered MT intervention or usual care. For every participant, the research team will measure maternal cardiovascular parameters (24-hour blood pressure and uterine artery resistance values by ultrasound Doppler) before and after the RCT. All participants will complete EMA for 2 weeks 'bursts' before and after the RCT to evaluate mechanisms of MT on cardiovascular parameters. EMA will include smartphone-app based experience sampling of psychological processes; smartphone-app based ambient audio sampling (i.e. the Electronically Activated Recorder [EAR] method) and wearable wrist-worn biosensor monitoring of physiological responses (heart rate and heart rate variability) to everyday experiences. Results will provide new insights into 1) effects of MT on cardiovascular parameters in pregnancy, 2) pathophysiological mechanisms of HDP, and 3) targets for new HDP prevention strategies.

Being tested
Mindfulness training
Keywords
mindfulness, pregnancy, blood pressure, ecological momentary assessment
Medical subject headings
Hypertension, Pregnancy-Induced

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness trainingBehavioural

    Phone-delivered brief mindfulness training based on principles of MBSR

Study groups in NCT04626245
Study groupRoleWhat they receive
Mindfulness trainingExperimentalPhone-delivered mindfulness training
Receives: Behavioral: Mindfulness training
Treatment as usualOtherPrenatal care
Receives: Behavioral: Mindfulness training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perceived stress and mood responses to momentary stress

    Ecological momentary assessment surveys will query for maternal mood and perceived stress throughout the day.

    Measured: Before and after the intervention, approximately 3 months

Secondary outcomes (2)
  1. Heart rate response to momentary stress

    Measured: Before and after the intervention, approximately 3 months

  2. Perceived and received support in response to momentary stress

    Ecological momentary assessment and audio recording will be used to measure perceived and received social support and loneliness throughout the day.

    Measured: Before and after the intervention, approximately 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2020
  2. Study start13 Jun 2022
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized to a mindfulness training condition or treatment as usual.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04626245
Sponsor's protocol ID
1679889-1
Status last verified
Aug 2026
First submitted
5 Nov 2020
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness training in people with Hypertension in Pregnancy, run by Lifespan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceived stress and mood responses to momentary stress (time frame: Before and after the intervention, approximately 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.

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