search
Back to results

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
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypertension in Pregnancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

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

    First Posted
    July 11, 2022
    Last Updated
    July 14, 2022
    Sponsor
    Massachusetts General Hospital
    search

    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

    We'll reach out to this number within 24 hrs