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Clinical Trials/NCT05457504
NCT05457504
Unknown
Not Applicable

Blood Pressure Monitoring in Postpartum Women at Risk of Hypertension

Massachusetts General Hospital0 sites200 target enrollmentJuly 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension in Pregnancy
Sponsor
Massachusetts General Hospital
Enrollment
200
Primary Endpoint
Percent of patients who are normotensive at 6 weeks postpartum by American College of Cardiology (ACC)/American Heart Association (AHA) guidelines
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2022
End Date
December 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ilona T. Goldfarb, M.D.

Principal Investigator

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

Outcomes

Primary Outcomes

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

Time Frame: 6 weeks

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

Secondary Outcomes

  • Adherence with scheduled outpatient clinical appointments(6 months)
  • Establishment of care with a primary care doctor(1 year)
  • Frequency of Hospital readmission(6 weeks)
  • Percent of patients who are normotensive at 6 weeks postpartum by American College of Obstetricians and Gynecologists (ACOG) guidelines(6 weeks)
  • Number of medication titrations(6 weeks)

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