Blood Pressure Monitoring in Postpartum Women at Risk of Hypertension

Preeclampsia Clinical Trial

Official title:

Blood Pressure Monitoring in Postpartum Women at Risk of Hypertension

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05457504
• Other study ID #: 2021P003705
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Eclampsia
• Gestational Hypertension
• Hypertension
• Hypertension in Pregnancy
• Hypertension, Pregnancy-Induced
• Pre-Eclampsia
• Preeclampsia
• Pregnancy Complications

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