Blood Pressure Monitoring in Postpartum Women at Risk of Hypertension

NCT ID: NCT05457504

Last Updated: 2022-07-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-31
• Study Completion Date: 2023-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Experimental

Group Type: EXPERIMENTAL

Remote blood pressure monitoring

Intervention Type: BEHAVIORAL

Participants assigned to this arm will participate in the experimental intervention

Usual Care

Group Type: PLACEBO_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

Participants assigned to this arm will participate in a placebo intervention

Interventions

Remote blood pressure monitoring

Participants assigned to this arm will participate in the experimental intervention

Intervention Type: BEHAVIORAL

Usual Care

Participants assigned to this arm will participate in a placebo intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ilona T. Goldfarb, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ilona T Goldfarb, MD

Role: CONTACT

igoldfarb@partners.org

617-724-2640

Other Identifiers

2021P003705

Identifier Type: -

Identifier Source: org_study_id