Prenatal Mindfulness & Hypertension Study (HTN)
Primary Purpose
Hypertension in Pregnancy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Training
Sponsored by
About this trial
This is an interventional prevention trial for Hypertension in Pregnancy focused on measuring mindfulness, pregnancy, hypertension
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).
Sites / Locations
- Women's Medicine Collaborative
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mindfulness Training
Treatment as Usual
Arm Description
Phone-delivered mindfulness training
Prenatal care
Outcomes
Primary Outcome Measures
Retention and Adherence
Number of participants that completed greater than 5 mindfulness sessions or completed the follow up interview.
Secondary Outcome Measures
Hypertension Diagnosis
Number of participants with a diagnosis of hypertensive disorders of pregnancy
Full Information
NCT ID
NCT03679117
First Posted
August 28, 2018
Last Updated
May 31, 2023
Sponsor
Lifespan
Collaborators
National Institute of General Medical Sciences (NIGMS)
1. Study Identification
Unique Protocol Identification Number
NCT03679117
Brief Title
Prenatal Mindfulness & Hypertension Study
Acronym
HTN
Official Title
Prenatal Mindfulness Training for Pregnant Women at Risk for Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lifespan
Collaborators
National Institute of General Medical Sciences (NIGMS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension in Pregnancy
Keywords
mindfulness, pregnancy, hypertension
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized trial in which participants are assigned to mindfulness training or treatment as usual.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Training
Arm Type
Experimental
Arm Description
Phone-delivered mindfulness training
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Prenatal care
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Training
Intervention Description
Phone-delivered mindfulness training. 8 weeks of 30 minute phone sessions with an instructor, plus 15 minutes of self-guided practice.
Primary Outcome Measure Information:
Title
Retention and Adherence
Description
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
Secondary Outcome Measure Information:
Title
Hypertension Diagnosis
Description
Number of participants with a diagnosis of hypertensive disorders of pregnancy
Time Frame
Through study completion, an average of 20 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Bublitz, PhD
Organizational Affiliation
Women's Medicine Collaborative
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's Medicine Collaborative
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
20904
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prenatal Mindfulness & Hypertension Study
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