Prenatal Mindfulness & Hypertension Study
Condition: Hypertension in Pregnancy
MeSH terms: Hypertension, Pregnancy-Induced; Hypertension
Study type: Interventional

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.
    

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.
    

Intervention name(s): Mindfulness Training
Intervention type(s): Behavioral
Intervention description(s): Phone-delivered mindfulness training. 8 weeks of 30 minute phone sessions with an instructor, plus 15 minutes of self-guided practice.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized trial in which participants are assigned to mindfulness training or treatment as usual.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: mindfulness; pregnancy; hypertension