CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Mindfulness Trainingbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03679117
NCT03679117N/ACompleted

Prenatal Mindfulness Training for Pregnant Women at Risk for Hypertension

Lifespan·interventional·Posted Sep 20, 2018·Updated Jun 1, 2023

In Brief

A clinical study evaluating Mindfulness Training for Hypertension in Pregnancy. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedSep 20, 2018
Enrollment StartApr 1, 2019
Primary CompletionJan 31, 2022
Study CompletionJul 1, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 7.8 years ago

Interventions

Mindfulness Trainingbehavioral

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