N/A
N=29
Prenatal Mindfulness & Hypertension Study
Hypertension in Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT03679117 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Retention and Adherence — 12; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindfulness Training (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Lifespan
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retention and Adherence |
12; 11 | — |
| SECONDARY Hypertension Diagnosis |
4; 4 | — |
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.
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).
Data sourced from ClinicalTrials.gov (NCT03679117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.