Hypertension in Pregnancy
Conditions
Keywords
mindfulness, pregnancy, hypertension
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.
Interventions
Phone-delivered mindfulness training. 8 weeks of 30 minute phone sessions with an instructor, plus 15 minutes of self-guided practice.
Sponsors
Study design
Intervention model description
Randomized trial in which participants are assigned to mindfulness training or treatment as usual.
Eligibility
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention and Adherence | Through study completion, an average of 20 weeks | Number of participants that completed greater than 5 mindfulness sessions or completed the follow up interview. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypertension Diagnosis | Through study completion, an average of 20 weeks | Number of participants with a diagnosis of hypertensive disorders of pregnancy |
Countries
United States
Participant flow
Pre-assignment details
One participant withdrew prior to randomization. This is why 30 participants were enrolled and 29 randomized.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| Treatment as Usual Usual prenatal care to prevent and treat hypertension | 14 |
| Total | 29 |
Baseline characteristics
| Characteristic | Mindfulness Training | Treatment as Usual | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 14 Participants | 29 Participants |
| Age, Continuous | 33 years STANDARD_DEVIATION 4 | 32 years STANDARD_DEVIATION 5 | 32 years STANDARD_DEVIATION 4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 12 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 11 Participants | 9 Participants | 20 Participants |
| Region of Enrollment United States | 15 participants | 14 participants | 29 participants |
| Sex: Female, Male Female | 15 Participants | 14 Participants | 29 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Systolic blood pressure | 117 mmHg STANDARD_DEVIATION 11 | 125 mmHg STANDARD_DEVIATION 14 | 121 mmHg STANDARD_DEVIATION 13 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 14 |
| other Total, other adverse events | 8 / 15 | 8 / 14 |
| serious Total, serious adverse events | 0 / 15 | 0 / 14 |
Outcome results
Retention and Adherence
Number of participants that completed greater than 5 mindfulness sessions or completed the follow up interview.
Time frame: Through study completion, an average of 20 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mindfulness Training | Retention and Adherence | 12 Participants |
| Treatment as Usual | Retention and Adherence | 11 Participants |
Hypertension Diagnosis
Number of participants with a diagnosis of hypertensive disorders of pregnancy
Time frame: Through study completion, an average of 20 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mindfulness Training | Hypertension Diagnosis | 4 Participants |
| Treatment as Usual | Hypertension Diagnosis | 4 Participants |