Blood Pressure Monitoring in Postpartum Women at Risk of Hypertension
Primary Purpose
Hypertension in Pregnancy, Preeclampsia, Gestational Hypertension
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Remote blood pressure monitoring
Usual Care
Sponsored by
About this trial
This is an interventional other trial for Hypertension in Pregnancy
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental
Usual Care
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Frequency of Hospital readmission
Frequency of Hospital readmission in the first 6 weeks postpartum in each treatment group
Number of medication titrations
Mean number of medication titrations by patient in the first 6 postpartum weeks in each treatment group
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
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
Full Information
NCT ID
NCT05457504
First Posted
July 11, 2022
Last Updated
July 14, 2022
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05457504
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2022 (Anticipated)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension in Pregnancy, Preeclampsia, Gestational Hypertension, Chronic Hypertension With Pre-Eclampsia, Hypertension Complicating Pregnancy, Childbirth, and the Puerperium
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Remote blood pressure monitoring
Intervention Description
Participants assigned to this arm will participate in the experimental intervention
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Participants assigned to this arm will participate in a placebo intervention
Primary Outcome Measure Information:
Title
Percent of patients who are normotensive at 6 weeks postpartum by American College of Cardiology (ACC)/American Heart Association (AHA) guidelines
Description
Percent of patients who are normotensive at 6 weeks postpartum by ACC/AHA guidelines (>130/80) in each treatment group
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Percent of patients who are normotensive at 6 weeks postpartum by American College of Obstetricians and Gynecologists (ACOG) guidelines
Description
Percent of patients who are normotensive at 6 weeks postpartum by ACOG guidelines (>140/90) in each treatment group
Time Frame
6 weeks
Title
Frequency of Hospital readmission
Description
Frequency of Hospital readmission in the first 6 weeks postpartum in each treatment group
Time Frame
6 weeks
Title
Number of medication titrations
Description
Mean number of medication titrations by patient in the first 6 postpartum weeks in each treatment group
Time Frame
6 weeks
Title
Adherence with scheduled outpatient clinical appointments
Description
Percent of scheduled outpatient clinical appointments attended by patients in the first 6 postpartum months in each treatment group
Time Frame
6 months
Title
Establishment of care with a primary care doctor
Description
Percent of patients who attend a primary care doctor visit in the first postpartum year in each treatment group
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilona T Goldfarb, MD
Phone
617-724-2640
Email
igoldfarb@partners.org
12. IPD Sharing Statement
Learn more about this trial
Blood Pressure Monitoring in Postpartum Women at Risk of Hypertension
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