Blood Pressure Monitoring in Postpartum Women at Risk of Hypertension

NCT05457504 | Unknown

• 1 other identifier: 2021P003705
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cardiovascular disease and hypertensive disorders of pregnancy (HDP) are the leading causes of maternal morbidity and mortality in the United States. Postpartum, in office care has demonstrated to be an insufficient model of hypertensive management postpartum, largely due to barriers that women face in accessing in office care, with stark racial disparities in access. The care of postpartum patients with HDP following delivery is made up of either a single postpartum visit at 6 weeks postpartum or a fragmented and non-standardized series of in-person appointments depending on the patients' medical complications and the clinicians' experience. Further, current society guidelines outline inpatient thresholds for initiation of antihypertensive medication but do not provide recommendations for titration thereafter. The proposed study will investigate the acceptability and effectiveness of an algorithm-based, outpatient treatment model for the management of postpartum hypertension utilizing an asynchronous text-based platform as compared to the standard of care for postpartum women with a diagnosis of Hypertensive disorder of pregnancy at Massachusetts General Hospital.

Conditions

Hypertension in Pregnancy; Preeclampsia; Gestational Hypertension; Chronic Hypertension With Pre-Eclampsia; Hypertension Complicating Pregnancy, Childbirth, and the Puerperium

Outcome Measures

Primary Outcomes (1)

• Percent of patients who are normotensive at 6 weeks postpartum by American College of Cardiology (ACC)/American Heart Association (AHA) guidelines

  Percent of patients who are normotensive at 6 weeks postpartum by ACC/AHA guidelines (\>130/80) in each treatment group

  6 weeks

Secondary Outcomes (5)

• Percent of patients who are normotensive at 6 weeks postpartum by American College of Obstetricians and Gynecologists (ACOG) guidelines

  6 weeks

• Frequency of Hospital readmission

  6 weeks

• Number of medication titrations

  6 weeks

• Adherence with scheduled outpatient clinical appointments

  6 months

• Establishment of care with a primary care doctor

  1 year

Study Arms (2)

Experimental

EXPERIMENTAL

Behavioral: Remote blood pressure monitoring

Usual Care

PLACEBO COMPARATOR

Behavioral: Usual Care

Interventions

Remote blood pressure monitoring BEHAVIORAL

Participants assigned to this arm will participate in the experimental intervention

Experimental

Usual Care BEHAVIORAL

Participants assigned to this arm will participate in a placebo intervention

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Diagnosis of gestational hypertension (Systolic Blood Pressure (SBP)≥140 or Diastolic Blood Pressure (DBP) ≥90 on at least two occasions at least 4 hours apart after 20 weeks gestation in previously normotensive women) and or preeclampsia (SBP≥140 or DBP ≥90, proteinuria with or without symptoms of preeclampsia (headache, vision changes, right upper quadrant pain), and presentation of symptoms/lab abnormalities but no proteinuria)
• English and Spanish-speaking
• Delivering at Massachusetts General Hospital

You may not qualify if:

• Chronic hypertension or underlying cardiovascular disease

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Pre-Eclampsia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ilona T Goldfarb, MD

CONTACT

617-724-2640; igoldfarb@partners.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: In this study, we are testing different strategies to help women decrease issues with hypertension in the postpartum period. Participants may or may not undergo some of the following study procedures: * Frequent blood pressure monitoring and feedback * Receive information related to blood pressure measurement, heart disease prevention, etc. * Regular blood pressure monitoring and advice regarding changes in medications.

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 14, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 18, 2022

Record last verified: 2022-07