Clinical trial NCT05457504: Blood Pressure Monitoring in Postpartum Women at Risk of Hypertension
Official title: Blood Pressure Monitoring in Postpartum Women at Risk of Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension in Pregnancy
Preeclampsia
Gestational Hypertension
Chronic Hypertension With Pre-Eclampsia
Hypertension Complicating Pregnancy, Childbirth, and the Puerperium
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Percent of patients who are normotensive at 6 weeks postpartum by American College of Cardiology (ACC)/American Heart Association (AHA) guidelines
timeFrame: 6 weeks
Secondary outcomes:
measure: Percent of patients who are normotensive at 6 weeks postpartum by American College of Obstetricians and Gynecologists (ACOG) guidelines
timeFrame: 6 weeks
measure: Frequency of Hospital readmission
timeFrame: 6 weeks
measure: Number of medication titrations
timeFrame: 6 weeks
measure: Adherence with scheduled outpatient clinical appointments
timeFrame: 6 months
measure: Establishment of care with a primary care doctor
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
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