Hypertension in PregnancyHTNNCT03679117
Prenatal Mindfulness & Hypertension Study
A study testing Mindfulness Training in people with Hypertension in Pregnancy, run by Lifespan at 1 site in United States.
Trial summary
Hypertensive disorders of pregnancy are one of the greatest causes of death to mothers and babies. These disorders affect 1 out of every 10 pregnancies, the rate is increasing in the United States, and rate of recurrence is as high as 50%. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension in Pregnancy
- What is being tested?
- Mindfulness Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- > 18 years old,
- Singleton pregnancy,
- English speaking,
- <20 weeks' gestation at enrollment,
- History of a hypertensive disorder in a prior pregnancy.
Who cannot join
- No current engagement in mindfulness training (defined as weekly yoga, mindfulness exercises (including on-line), or meditation).
Trial locations and contacts
1 site in 1 country.
United States1 site
Women's Medicine Collaborative
Providence, Rhode Island, 20904
About this study
Official title: Prenatal Mindfulness Training for Pregnant Women at Risk for Hypertension
Hypertensive disorders of pregnancy are one of the greatest causes of death to mothers and babies. These disorders affect 1 out of every 10 pregnancies, the rate is increasing in the United States, and rate of recurrence is as high as 50%. Treatments to prevent hypertensive disorders of pregnancy from happening in future pregnancies are limited. There are currently no effective interventions to prevent hypertension recurrence in pregnancy that do not involve medications.
Mindfulness interventions hold great potential as a medication-free approach to prevent the recurrence of hypertension in pregnant women with histories of hypertensive disorders. However, traditional group-based mindfulness training interventions, requiring 2.5 hours of class attendance for 8 weeks plus a full-day retreat, are very difficult for pregnant women with medical conditions to attend.
The goal of the current study is to determine if phone-delivered mindfulness training is an acceptable intervention among pregnant women with histories of hypertensive disorders of pregnancy. 20 pregnant women with histories of hypertensive disorders of pregnancy will be randomly picked to participate in an 8-week phone-delivered mindfulness training intervention (N=10) or usual care (N=10). All women will undergo blood pressure monitoring before and after the intervention. The investigators predict that phone-delivered mindfulness training will reduce risk for hypertension recurrence.
Read the detailed description
Hypertensive disorders of pregnancy are one of the greatest causes of perinatal morbidity and mortality. Hypertensive disorders of pregnancy affect 1 out of every 10 pregnancies, the rate has increased substantially over the past several decades, and rates of recurrence are as high as 50%. Treatments to prevent the recurrence of hypertension are extremely limited and include watchful waiting, anti-hypertensive medications, or ultimately, early delivery. There are currently no effective alternatives to pharmacological interventions to prevent hypertension recurrence in pregnancy.
Mindfulness interventions hold great potential as a non-pharmacological approach to reduce stress and prevent the recurrence of hypertension in pregnant women with histories of hypertensive disorders. However, traditional group-based mindfulness training interventions, requiring 2.5 hours of class attendance for 8 weeks plus a full-day retreat, are infeasible in pregnancies complicated by hypertensive disorders due to the need for activity restriction, hospitalization, and increased maternal and fetal monitoring.
The goal of the current study is to determine if phone-delivered mindfulness training is feasible and acceptable among pregnant women with histories of hypertensive disorders of pregnancy. 20 pregnant women with histories of hypertensive disorders of pregnancy will be randomized to an 8-week phone-delivered mindfulness training intervention (N=10) or usual care (N=10). All women will undergo 24-hour ambulatory blood pressure monitoring before and after the intervention. The investigators will used a mixed-methods approach using both quantitative and qualitative data to examine feasibility/acceptability. The working hypothesis, to be tested in a fully-powered randomized controlled trial, is that phone-delivered mindfulness training will reduce risk for hypertension recurrence.
- Conditions
- Hypertension in Pregnancy
- Being tested
- Mindfulness Training
- Keywords
- mindfulness, pregnancy, hypertension
- Medical subject headings
- Hypertension, Pregnancy-Induced, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness TrainingBehavioural
Phone-delivered mindfulness training. 8 weeks of 30 minute phone sessions with an instructor, plus 15 minutes of self-guided practice.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Training | Experimental | Phone-delivered mindfulness training Receives: Behavioral: Mindfulness Training |
| Treatment as Usual | No intervention | Prenatal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention and Adherence
Number of participants that completed greater than 5 mindfulness sessions or completed the follow up interview.
Measured: Through study completion, an average of 20 weeks
Secondary outcomes (1)
Hypertension Diagnosis
Number of participants with a diagnosis of hypertensive disorders of pregnancy
Measured: Through study completion, an average of 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start1 Apr 2019
- Primary completion31 Jan 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hypertension in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomized trial in which participants are assigned to mindfulness training or treatment as usual.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lifespan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Margaret Bublitz, Lifespan
- Investigators
- Margaret Bublitz, PhD, Principal investigator, Women's Medicine Collaborative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679117
- Sponsor's protocol ID
- 1303286
- Other IDs
- P20GM103652
- Acronym
- HTN
- Status last verified
- May 2023
- First submitted
- 28 Aug 2018
- Last updated
- 1 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bublitz MH, Anderson M, Bourjeily G, Salmoirago-Blotcher E. Psychological mechanisms of prenatal mindfulness training on antenatal blood pressure reduction: A pilot study. J Psychosom Res. 2025 Aug;195:112183. doi: 10.1016/j.jpsychores.2025.112183. Epub 2025 Jun 6.
PubMed 40505593Sharp M, Ward LG, Pomerantz M, Bourjeily G, Guthrie KM, Salmoirago-Blotcher E, Desmarattes A, Bublitz MH. Prenatal Mindfulness Training and Interoceptive Awareness in Pregnant People at Risk for Hypertensive Disorders. J Integr Complement Med. 2024 Dec;30(12):1200-1208. doi: 10.1089/jicm.2024.0121. Epub 2024 Jul 8.
PubMed 38976481Unger KG, Sanapo L, Bourjeily G, Salmoirago-Blotcher E, Bublitz MH. The Impact of Mindfulness Treatment on Maternal Inflammation and Fetal Neurodevelopment Among Participants with Histories of Hypertensive Disorders. J Integr Complement Med. 2024 Jan;30(1):85-89. doi: 10.1089/jicm.2023.0254. Epub 2023 Sep 26.
PubMed 37751286Bublitz MH, Salmoirago-Blotcher E, Sanapo L, Ayala N, Mehta N, Bourjeily G. Feasibility, acceptability, and preliminary effects of mindfulness training on antenatal blood pressure. J Psychosom Res. 2023 Feb;165:111146. doi: 10.1016/j.jpsychores.2023.111146. Epub 2023 Jan 5.
PubMed 36621212
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Mindfulness Training for Pregnant Women at Risk for Hypertension
- ClinicalTrials.gov ID
- NCT03679117
- Acronym / sponsor ID
- HTN / 1303286
- Conditions
- Hypertension in Pregnancy
- Keywords
- mindfulness, pregnancy, hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- LifespanUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 20 Sep 2018 (actual)
- Results
- Posted 1 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypertensive disorders of pregnancy are one of the greatest causes of death to mothers and babies. These disorders affect 1 out of every 10 pregnancies, the rate is increasing in the United States, and rate of recurrence is as high as 50%. Treatments to prevent hypertensive disorders of pregnancy from happening in future pregnancies are limited. There are currently no effective interventions to prevent hypertension recurrence in pregnancy that do not involve medications.
Mindfulness interventions hold great potential as a medication-free approach to prevent the recurrence of hypertension in pregnant women with histories of hypertensive disorders. However, traditional group-based mindfulness training interventions, requiring 2.5 hours of class attendance for 8 weeks plus a full-day retreat, are very difficult for pregnant women with medical conditions to attend.
The goal of the current study is to determine if phone-delivered mindfulness training is an acceptable intervention among pregnant women with histories of hypertensive disorders of pregnancy. 20 pregnant women with histories of hypertensive disorders of pregnancy will be randomly picked to participate in an 8-week phone-delivered mindfulness training intervention (N=10) or usual care (N=10). All women will undergo blood pressure monitoring before and after the intervention. The investigators predict that phone-delivered mindfulness training will reduce risk for hypertension recurrence.
Detailed description
Hypertensive disorders of pregnancy are one of the greatest causes of perinatal morbidity and mortality. Hypertensive disorders of pregnancy affect 1 out of every 10 pregnancies, the rate has increased substantially over the past several decades, and rates of recurrence are as high as 50%. Treatments to prevent the recurrence of hypertension are extremely limited and include watchful waiting, anti-hypertensive medications, or ultimately, early delivery. There are currently no effective alternatives to pharmacological interventions to prevent hypertension recurrence in pregnancy.
Mindfulness interventions hold great potential as a non-pharmacological approach to reduce stress and prevent the recurrence of hypertension in pregnant women with histories of hypertensive disorders. However, traditional group-based mindfulness training interventions, requiring 2.5 hours of class attendance for 8 weeks plus a full-day retreat, are infeasible in pregnancies complicated by hypertensive disorders due to the need for activity restriction, hospitalization, and increased maternal and fetal monitoring.
The goal of the current study is to determine if phone-delivered mindfulness training is feasible and acceptable among pregnant women with histories of hypertensive disorders of pregnancy. 20 pregnant women with histories of hypertensive disorders of pregnancy will be randomized to an 8-week phone-delivered mindfulness training intervention (N=10) or usual care (N=10). All women will undergo 24-hour ambulatory blood pressure monitoring before and after the intervention. The investigators will used a mixed-methods approach using both quantitative and qualitative data to examine feasibility/acceptability. The working hypothesis, to be tested in a fully-powered randomized controlled trial, is that phone-delivered mindfulness training will reduce risk for hypertension recurrence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized trial in which participants are assigned to mindfulness training or treatment as usual.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Training | Experimental | Behavioral: Mindfulness TrainingPhone-delivered mindfulness training |
| Treatment as Usual | No intervention | –Prenatal care |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- > 18 years old,
- Singleton pregnancy,
- English speaking,
- <20 weeks' gestation at enrollment,
- History of a hypertensive disorder in a prior pregnancy.
Key exclusion criteria (1 listed)
- No current engagement in mindfulness training (defined as weekly yoga, mindfulness exercises (including on-line), or meditation).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness TrainingPhone-delivered mindfulness training. 8 weeks of 30 minute phone sessions with an instructor, plus 15 minutes of self-guided practice. | Behavioural | Mindfulness Training |
Primary outcome
Retention and Adherence
Time frame: Through study completion, an average of 20 weeks
Number of participants that completed greater than 5 mindfulness sessions or completed the follow up interview.
1 secondary outcome
Hypertension Diagnosis
Time frame: Through study completion, an average of 20 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40505593Bublitz MH, Anderson M, Bourjeily G, Salmoirago-Blotcher E. Psychological mechanisms of prenatal mindfulness training on antenatal blood pressure reduction: A pilot study. J Psychosom Res. 2025 Aug;195:112183. doi: 10.1016/j.jpsychores.2025.112183. Epub 2025 Jun 6.
- Derived from this study: PubMed 38976481Sharp M, Ward LG, Pomerantz M, Bourjeily G, Guthrie KM, Salmoirago-Blotcher E, Desmarattes A, Bublitz MH. Prenatal Mindfulness Training and Interoceptive Awareness in Pregnant People at Risk for Hypertensive Disorders. J Integr Complement Med. 2024 Dec;30(12):1200-1208. doi: 10.1089/jicm.2024.0121. Epub 2024 Jul 8.
- Derived from this study: PubMed 37751286Unger KG, Sanapo L, Bourjeily G, Salmoirago-Blotcher E, Bublitz MH. The Impact of Mindfulness Treatment on Maternal Inflammation and Fetal Neurodevelopment Among Participants with Histories of Hypertensive Disorders. J Integr Complement Med. 2024 Jan;30(1):85-89. doi: 10.1089/jicm.2023.0254. Epub 2023 Sep 26.
- Derived from this study: PubMed 36621212Bublitz MH, Salmoirago-Blotcher E, Sanapo L, Ayala N, Mehta N, Bourjeily G. Feasibility, acceptability, and preliminary effects of mindfulness training on antenatal blood pressure. J Psychosom Res. 2023 Feb;165:111146. doi: 10.1016/j.jpsychores.2023.111146. Epub 2023 Jan 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Bublitz, PhD principal investigator
Women's Medicine Collaborative
1 site in 1 country: see every site and its status.
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 1 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: finished, as of the sponsor's last update on 1 Jun 2023. 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?
Yes. Results are posted in the registry (first posted 1 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Retention and Adherence (time frame: Through study completion, an average of 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03679117, which also lists 4 linked publications.
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 1 Jun 2023.