Blood Pressure Monitoring in Postpartum Women at Risk of Hypertension

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Preeclampsia; Hypertension in Pregnancy; Gestational Hypertension; Chronic Hypertension With Pre-Eclampsia; Hypertension Complicating Pregnancy, Childbirth, and the Puerperium
• Intervention / Treatment: Behavioral: Remote blood pressure monitoring; Behavioral: Usual Care

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ilona T Goldfarb, MD; Phone Number: 617-724-2640; Email: igoldfarb@partners.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Chronic hypertension or underlying cardiovascular disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental	Behavioral: Remote blood pressure monitoring; Participants assigned to this arm will participate in the experimental intervention
Placebo Comparator: Usual Care	Behavioral: Usual Care; Participants assigned to this arm will participate in a placebo intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of patients who are normotensive at 6 weeks postpartum by American College of Obstetricians and Gynecologists (ACOG) guidelines	Percent of patients who are normotensive at 6 weeks postpartum by ACOG guidelines (>140/90) in each treatment group	6 weeks
Frequency of Hospital readmission	Frequency of Hospital readmission in the first 6 weeks postpartum in each treatment group	6 weeks
Number of medication titrations	Mean number of medication titrations by patient in the first 6 postpartum weeks in each treatment group	6 weeks
Adherence with scheduled outpatient clinical appointments	Percent of scheduled outpatient clinical appointments attended by patients in the first 6 postpartum months in each treatment group	6 months
Establishment of care with a primary care doctor	Percent of patients who attend a primary care doctor visit in the first postpartum year in each treatment group	1 year

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Eclampsia; Pre-Eclampsia; Pregnancy Complications; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: 2021P003705

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No