HTN: Prenatal Mindfulness & Hypertension Study
Study Details
Study Description
Brief 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%. 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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Mindfulness Training Phone-delivered mindfulness training |
Behavioral: Mindfulness Training
Phone-delivered mindfulness training. 8 weeks of 30 minute phone sessions with an instructor, plus 15 minutes of self-guided practice.
|
No Intervention: Treatment as Usual Prenatal care |
Outcome Measures
Primary Outcome Measures
- Retention and Adherence [Through study completion, an average of 20 weeks]
Number of sessions attended, drop outs, lost to follow up
Secondary Outcome Measures
- Hypertension diagnosis [Through study completion, an average of 20 weeks]
Chart review information on hypertension diagnoses in pregnancy
Eligibility Criteria
Criteria
Inclusion criteria:
-
18 years old,
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Singleton pregnancy,
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English speaking,
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<20 weeks' gestation at enrollment,
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History of a hypertensive disorder in a prior pregnancy.
Exclusion criteria:
- No current engagement in mindfulness training (defined as weekly yoga, mindfulness exercises (including on-line), or meditation).
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Women's Medicine Collaborative | Providence | Rhode Island | United States | 20904 |
Sponsors and Collaborators
- Lifespan
Investigators
- Principal Investigator: Margaret Bublitz, PhD, Women's Medicine Collaborative
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1303286