Blood Pressure Monitoring in Postpartum Women at Risk of Hypertension

Mass General Brigham

Status: Not yet enrolling

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

Treatments: Behavioral: Remote blood pressure monitoring; Behavioral: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05457504

2021P003705

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Treatment:

Behavioral: Remote blood pressure monitoring

Usual Care

Placebo Comparator group

Treatment:

Behavioral: Usual Care