Protocol for a randomized controlled trial comparing phone-based prenatal mindfulness training to usual care for pregnant people at risk for hypertensive disorders of pregnancy

Contemp Clin Trials. 2024 Oct:145:107661. doi: 10.1016/j.cct.2024.107661. Epub 2024 Aug 8.

Abstract

Hypertensive disorders of pregnancy (HDP) are the most common medical conditions in pregnancy and a leading cause of maternal morbidity and mortality in the United States. There are few interventions available to prevent HDP, and those currently available do not target underlying mechanisms of disease. Mindfulness training (MT) is effective at reducing blood pressure in non-pregnant patients with pre-hypertension and hypertension and has proven more effective at blood pressure reduction than other stress management interventions. MT thus holds great promise as a mind-body intervention to prevent HDP. This randomized trial will harness subjective and objective ecological momentary assessment methodology combined with wearable biosensor technology to capture psychological, physiological, and interpersonal processes through which MT may lead to improved maternal cardiovascular parameters. Pregnant women at risk for HDP will be randomized to an 8-week phone-delivered MT intervention or usual care. Through these methods, we will evaluate psychological, physiological, and interpersonal responses to daily experiences linking MT to cardiovascular parameters among women at risk for HDP.

Keywords: Hypertensive disorders of pregancy; Mechanisms; Mindfulness; Pregnancy.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Adult
  • Blood Pressure
  • Ecological Momentary Assessment
  • Female
  • Humans
  • Hypertension, Pregnancy-Induced* / therapy
  • Mindfulness* / methods
  • Pregnancy
  • Prenatal Care / methods
  • Prenatal Care / organization & administration
  • Randomized Controlled Trials as Topic
  • Telephone
  • Wearable Electronic Devices