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Prenatal Mindfulness & Hypertension Study

Prenatal Mindfulness Training for Pregnant Women at Risk for Hypertension

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03679117
Acronym
HTN
Enrollment
30
Registered
2018-09-20
Start date
2019-04-01
Completion date
2022-07-01
Last updated
2023-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension in Pregnancy

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

BEHAVIORALMindfulness Training

Phone-delivered mindfulness training. 8 weeks of 30 minute phone sessions with an instructor, plus 15 minutes of self-guided practice.

Sponsors

National Institute of General Medical Sciences (NIGMS)
CollaboratorNIH
Lifespan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Randomized trial in which participants are assigned to mindfulness training or treatment as usual.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Retention and AdherenceThrough study completion, an average of 20 weeksNumber of participants that completed greater than 5 mindfulness sessions or completed the follow up interview.

Secondary

MeasureTime frameDescription
Hypertension DiagnosisThrough study completion, an average of 20 weeksNumber 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

ArmCount
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
Total29

Baseline characteristics

CharacteristicMindfulness TrainingTreatment as UsualTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
15 Participants14 Participants29 Participants
Age, Continuous33 years
STANDARD_DEVIATION 4
32 years
STANDARD_DEVIATION 5
32 years
STANDARD_DEVIATION 4
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants2 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
13 Participants12 Participants25 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
2 Participants3 Participants5 Participants
Race (NIH/OMB)
More than one race
1 Participants2 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
11 Participants9 Participants20 Participants
Region of Enrollment
United States
15 participants14 participants29 participants
Sex: Female, Male
Female
15 Participants14 Participants29 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
Systolic blood pressure117 mmHg
STANDARD_DEVIATION 11
125 mmHg
STANDARD_DEVIATION 14
121 mmHg
STANDARD_DEVIATION 13

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 150 / 14
other
Total, other adverse events
8 / 158 / 14
serious
Total, serious adverse events
0 / 150 / 14

Outcome results

Primary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mindfulness TrainingRetention and Adherence12 Participants
Treatment as UsualRetention and Adherence11 Participants
Secondary

Hypertension Diagnosis

Number of participants with a diagnosis of hypertensive disorders of pregnancy

Time frame: Through study completion, an average of 20 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Mindfulness TrainingHypertension Diagnosis4 Participants
Treatment as UsualHypertension Diagnosis4 Participants

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026