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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05457504
Other study ID # 2021P003705
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2022
Est. completion date December 2023

Study information

Verified date July 2022
Source Massachusetts General Hospital
Contact Ilona T Goldfarb, MD
Phone 617-724-2640
Email igoldfarb@partners.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date December 2023
Est. primary completion date July 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Remote blood pressure monitoring
Participants assigned to this arm will participate in the experimental intervention
Usual Care
Participants assigned to this arm will participate in a placebo intervention

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Frequency of Hospital readmission Frequency of Hospital readmission in the first 6 weeks postpartum in each treatment group 6 weeks
Secondary Number of medication titrations Mean number of medication titrations by patient in the first 6 postpartum weeks in each treatment group 6 weeks
Secondary 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
Secondary 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
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