HTN: Prenatal Mindfulness & Hypertension Study

Sponsor
Lifespan (Other)
Overall Status
Completed
CT.gov ID
NCT03679117
Collaborator
(none)
30
1
2
39
0.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness Training
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized trial in which participants are assigned to mindfulness training or treatment as usual.Randomized trial in which participants are assigned to mindfulness training or treatment as usual.
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Prenatal Mindfulness Training for Pregnant Women at Risk for Hypertension
Actual Study Start Date :
Apr 1, 2019
Actual Primary Completion Date :
Jan 31, 2022
Actual Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mindfulness Training

Phone-delivered mindfulness training

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

No Intervention: Treatment as Usual

Prenatal care

Outcome Measures

Primary Outcome Measures

  1. Retention and Adherence [Through study completion, an average of 20 weeks]

    Number of sessions attended, drop outs, lost to follow up

Secondary Outcome Measures

  1. Hypertension diagnosis [Through study completion, an average of 20 weeks]

    Chart review information on hypertension diagnoses in pregnancy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Women's Medicine Collaborative Providence Rhode Island United States 20904

Sponsors and Collaborators

  • Lifespan

Investigators

  • Principal Investigator: Margaret Bublitz, PhD, Women's Medicine Collaborative

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Margaret Bublitz, Research Scientist, Lifespan
ClinicalTrials.gov Identifier:
NCT03679117
Other Study ID Numbers:
  • 1303286
First Posted:
Sep 20, 2018
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Margaret Bublitz, Research Scientist, Lifespan
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2022