Clinical trial NCT03679117: Prenatal Mindfulness & Hypertension Study
Official title: Prenatal Mindfulness Training for Pregnant Women at Risk for Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension in Pregnancy
Keywords: mindfulness
pregnancy
hypertension
Lead sponsor: Lifespan
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2018-09-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized trial in which participants are assigned to mindfulness training or treatment as usual.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion criteria:

* \> 18 years old,
* Singleton pregnancy,
* English speaking,
* \<20 weeks' gestation at enrollment,
* 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).

Primary outcomes:
measure: Retention and Adherence
timeFrame: Through study completion, an average of 20 weeks
Secondary outcomes:
measure: Hypertension Diagnosis
timeFrame: Through study completion, an average of 20 weeks
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women's Medicine Collaborative
state: Rhode Island
Study officials:
affiliation: Women's Medicine Collaborative
name: Margaret Bublitz, PhD
role: PRINCIPAL_INVESTIGATOR
References: