Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P20GM103652 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Training | Experimental | Phone-delivered mindfulness training |
|
| Treatment as Usual | No Intervention | Prenatal care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Training | Behavioral | Phone-delivered mindfulness training. 8 weeks of 30 minute phone sessions with an instructor, plus 15 minutes of self-guided practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Retention and Adherence | Number of participants that completed greater than 5 mindfulness sessions or completed the follow up interview. | Through study completion, an average of 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hypertension Diagnosis | Number of participants with a diagnosis of hypertensive disorders of pregnancy | Through study completion, an average of 20 weeks |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Margaret Bublitz, PhD | Women's Medicine Collaborative | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Medicine Collaborative | Providence | Rhode Island | 20904 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40505593 | Derived | 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. | |
| 38976481 | Derived | Sharp 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
One participant withdrew prior to randomization. This is why 30 participants were enrolled and 29 randomized.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness Training | Phone-delivered mindfulness training Mindfulness Training: Phone-delivered mindfulness training. 8 weeks of 30 minute phone sessions with an instructor, plus 15 minutes of self-guided practice. |
| FG001 | Treatment as Usual | Usual prenatal care to prevent and treat hypertension |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness Training | Phone-delivered mindfulness training Mindfulness Training: Phone-delivered mindfulness training. 8 weeks of 30 minute phone sessions with an instructor, plus 15 minutes of self-guided practice. |
| BG001 | Treatment as Usual |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Retention and Adherence | Number of participants that completed greater than 5 mindfulness sessions or completed the follow up interview. | Posted | Count of Participants | Participants | Through study completion, an average of 20 weeks |
|
Adverse events were recorded during participation in the RCT approximately 20 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mindfulness Training | Phone-delivered mindfulness training Mindfulness Training: Phone-delivered mindfulness training. 8 weeks of 30 minute phone sessions with an instructor, plus 15 minutes of self-guided practice. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margaret Bublitz | Lifespan Hospital | 401-323-3356 | mbublitz@lifespan.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 20, 2020 | May 31, 2023 | Prot_SAP_ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Randomized trial in which participants are assigned to mindfulness training or treatment as usual.
Not provided
Not provided
Not provided
| 37751286 | Derived | Unger 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. |
| 36621212 | Derived | Bublitz 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. |
Usual prenatal care to prevent and treat hypertension |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Systolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Hypertension Diagnosis | Number of participants with a diagnosis of hypertensive disorders of pregnancy | Posted | Count of Participants | Participants | Through study completion, an average of 20 weeks |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 8 |
| 15 |
| EG001 | Treatment as Usual | Usual prenatal care to prevent and treat hypertension | 0 | 14 | 0 | 14 | 8 | 14 |
| High blood pressure | Blood and lymphatic system disorders | Systematic Assessment |
|
Not provided
Not provided
| D002318 | Cardiovascular Diseases |