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Completed

NCT Number: NCT03679117

Prenatal Mindfulness & Hypertension Study

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women's Medicine Collaborative

Providence, Rhode Island, 20904, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Mindfulness Training

Behavioral

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

Primary outcomes

  1. Retention and Adherence

    Time frame: 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 outcomes

  1. Hypertension Diagnosis

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

    Number of participants with a diagnosis of hypertensive disorders of pregnancy

Sponsors and collaborators

Lead sponsor

Lifespan

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

Prenatal Mindfulness Training for Pregnant Women at Risk for Hypertension

Acronym: HTN

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 20, 2018
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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