Prenatal Mindfulness & Hypertension Study

NCT03679117 | Completed Results DMC

• 2 other identifiers: 1303286P20GM103652
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension in Pregnancy

Keywords

mindfulness; pregnancy; hypertension

Outcome Measures

Primary Outcomes (1)

• Retention and Adherence

  Number of participants that completed greater than 5 mindfulness sessions or completed the follow up interview.

  Through study completion, an average of 20 weeks

Secondary Outcomes (1)

• Hypertension Diagnosis

  Through study completion, an average of 20 weeks

Study Arms (2)

Mindfulness Training

EXPERIMENTAL

Phone-delivered mindfulness training

Behavioral: Mindfulness Training

Treatment as Usual

NO INTERVENTION

Prenatal care

Interventions

Mindfulness Training BEHAVIORAL

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

Mindfulness Training

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \> 18 years old,
• Singleton pregnancy,
• English speaking,
• \<20 weeks' gestation at enrollment,
• History of a hypertensive disorder in a prior pregnancy.

You may not qualify if:

• No current engagement in mindfulness training (defined as weekly yoga, mindfulness exercises (including on-line), or meditation).

Sponsors & Collaborators

• Lifespan: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Women's Medicine Collaborative

Providence, Rhode Island, 20904, United States

Location

Related Publications (4)

• Bublitz MH, Anderson M, Bourjeily G, Salmoirago-Blotcher E. Psychological mechanisms of prenatal mindfulness training on antenatal blood pressure reduction: A pilot study. J Psychosom Res. 2025 Aug;195:112183. doi: 10.1016/j.jpsychores.2025.112183. Epub 2025 Jun 6.

  PMID: 40505593 DERIVED

• Sharp M, Ward LG, Pomerantz M, Bourjeily G, Guthrie KM, Salmoirago-Blotcher E, Desmarattes A, Bublitz MH. Prenatal Mindfulness Training and Interoceptive Awareness in Pregnant People at Risk for Hypertensive Disorders. J Integr Complement Med. 2024 Dec;30(12):1200-1208. doi: 10.1089/jicm.2024.0121. Epub 2024 Jul 8.

  PMID: 38976481 DERIVED

• Unger KG, Sanapo L, Bourjeily G, Salmoirago-Blotcher E, Bublitz MH. The Impact of Mindfulness Treatment on Maternal Inflammation and Fetal Neurodevelopment Among Participants with Histories of Hypertensive Disorders. J Integr Complement Med. 2024 Jan;30(1):85-89. doi: 10.1089/jicm.2023.0254. Epub 2023 Sep 26.

  PMID: 37751286 DERIVED

• Bublitz MH, Salmoirago-Blotcher E, Sanapo L, Ayala N, Mehta N, Bourjeily G. Feasibility, acceptability, and preliminary effects of mindfulness training on antenatal blood pressure. J Psychosom Res. 2023 Feb;165:111146. doi: 10.1016/j.jpsychores.2023.111146. Epub 2023 Jan 5.

  PMID: 36621212 DERIVED

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Hypertension

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Margaret Bublitz
• Organization: Lifespan Hospital

mbublitz@lifespan.org

401-323-3356

Study Officials

• Margaret Bublitz, PhD

  Women's Medicine Collaborative

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Model Details: Randomized trial in which participants are assigned to mindfulness training or treatment as usual.

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: September 20, 2018
• Study Start: April 1, 2019
• Primary Completion: January 31, 2022
• Study Completion: July 1, 2022
• Last Updated: June 1, 2023
• Results First Posted: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)