STAMPP-HTN in a High-risk Rural Population of Women

Not Applicable

Completed

• Conditions: Hypertension in Pregnancy
• Interventions: Device: Home Blood Pressure Telemonitoring

• Registration Number: NCT04570124
• Lead Sponsor: University of Mississippi Medical Center

Brief Summary

The purpose of this study is to determine if monitored blood pressure paired with education reduces maternal mortality and morbidity during the post-partum period in a high-risk rural population of women.

Detailed Description

Women with hypertension during pregnancy are at an increased risk of maternal mortality (death during or within 42 days of termination of pregnancy) and hypertension related morbidity. Black women, women with lower education and less access to health care resources also have increased maternal mortality and morbidity. This project will use Bluetooth enabled blood pressure devices to monitor blood pressure in a population of postpartum women at increased risk for maternal mortality and morbidity. We will compare the number of postpartum hypertensive incidences and severities to a population of women who did not have a postpartum blood pressure control intervention.

Study Timeline

• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-09-24
• Study First Posted: 2020-09-30
• Study Start: 2020-12-14
• Primary Completion: 2021-09-30
• Study Completion: 2022-04-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-28
• Last Update Posted: 2022-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

1. Signed informed consent in a postpartum woman between 18-45 years of age at the time of study enrollment
2. Hospitalized for delivery with a hypertensive disorder of pregnancy as defined by ACOG 2019 Guidelines (chronic hypertension, HELLP syndrome, eclampsia, preeclampsia, gestational hypertension or new onset postpartum hypertension).
3. Ability to understand English or Spanish
4. Reliable access to the Internet and a Bluetooth mobile device
5. Willingness to download Omron Connect App and ability to use blood pressure monitor

Exclusion Criteria

1. Does not meet Inclusion criteria
2. Postpartum or operative complication that prolongs hospital stay beyond postpartum day 10.
3. Patients who are currently participating in another clinical trial to evaluate a therapeutic intervention for control of blood pressure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Remote Surveillance	Home Blood Pressure Telemonitoring	Women will use the home blood pressure monitoring device to record their blood pressure everyday for the first postpartum week, and then weekly until postpartum week 6.

Primary Outcome Measures

Name	Time	Method
Determine if HBPT decreases the severity of postpartum hypertension complication	9 months	Postpartum outcomes between women being monitored to those from the previous year who received no postpartum blood pressure monitoring will be compared. Women will be monitored and we measure Systolic, Diastolic and Mean arterial pressure and to see if HPBT decreases the severity of postpartum hypertension from previous baseline measurements from women who had no interventions. Percentages of patients with controlled blood pressure at each time point will be compared to previous BP measurements.

Secondary Outcome Measures

Name	Time	Method
Increase awareness and knowledge of postpartum blood pressure control in a group of high-risk women	9 months	A 9-question survey will be given before any hypertension education is conducted with study participants and again at the end of the 6-week study. The pre-test and post-test will measure if women are more knowledgeable of how to monitor postpartum blood pressure. We will calculate test scores and knowledge based on increase or decrease of correct answers after participants received education and training.
Assess compliance using HBPT and adherence to blood pressure medication	9 months	Study completion records (per week) will be compared with study covariates (i.e. maternal race, age, parity). The measurement of compliance across different subcategories will determine what population, race and age group is most compliant. Percentage of women who are correctly taking medication will be calculated.

Trial Locations

Locations (1)

University of MS Medical Center; 🇺🇸 Jackson, Mississippi, United States