Chronic Hypertension With Pre-Eclampsia, Gestational Hypertension, Hypertension Complicating Pregnancy, Childbirth, and the Puerperium, Hypertension in Pregnancy, Preeclampsia
Conditions
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.
Interventions
BEHAVIORALRemote blood pressure monitoring
Participants assigned to this arm will participate in the experimental intervention
BEHAVIORALUsual Care
Participants assigned to this arm will participate in a placebo intervention
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of patients who are normotensive at 6 weeks postpartum by American College of Cardiology (ACC)/American Heart Association (AHA) guidelines | 6 weeks | Percent of patients who are normotensive at 6 weeks postpartum by ACC/AHA guidelines (\>130/80) in each treatment group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of patients who are normotensive at 6 weeks postpartum by American College of Obstetricians and Gynecologists (ACOG) guidelines | 6 weeks | Percent of patients who are normotensive at 6 weeks postpartum by ACOG guidelines (\>140/90) in each treatment group |
| Frequency of Hospital readmission | 6 weeks | Frequency of Hospital readmission in the first 6 weeks postpartum in each treatment group |
| Number of medication titrations | 6 weeks | Mean number of medication titrations by patient in the first 6 postpartum weeks in each treatment group |
| Adherence with scheduled outpatient clinical appointments | 6 months | 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 | 1 year | Percent of patients who attend a primary care doctor visit in the first postpartum year in each treatment group |
Contacts
Primary ContactIlona T Goldfarb, MD
Outcome results
None listed