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

Implementing the Systemic Treatment and Management of Postpartum Hypertension (STAMPP-HTN) Bundle in a High-risk Mississippi Population

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.

Study Overview

• Status: Completed
• Conditions: Hypertension in Pregnancy
• Intervention / Treatment: Device: Home Blood Pressure Telemonitoring

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 Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of MS Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Remote Surveillance; 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.

Device: Home Blood Pressure Telemonitoring; Women will complete a 9-question survey (pre-education) prior to discharge and will go over an education video a study team member. Once discharged, women will be asked to measure their blood pressure daily for the first postpartum week, and then weekly until postpartum week 6. Women who have a doctor's visit scheduled during the first 10 days, a member of the study team will meet them there to assess blood pressure and answer any questions. Women who do not have a visit scheduled they will have a telehealth visit during days 8-10 to complete the same assessments. At the final visit, participants will measure their blood pressure via HBPT, prior to returning the unit, complete a post-education questionnaire, a post-study questionnaire and have any questions or concerns addressed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine if HBPT decreases the severity of postpartum hypertension complication	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.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase awareness and knowledge of postpartum blood pressure control in a group of high-risk women	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.	9 months
Assess compliance using HBPT and adherence to blood pressure medication	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.	9 months

Collaborators and Investigators

• Sponsor: University of Mississippi Medical Center
• Collaborators: University of Chicago
• Investigators: Principal Investigator: Kedra Wallace, PhD, University of Mississippi Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2020
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (Actual): September 30, 2020

Study Record Updates

• Last Update Posted (Estimate): December 29, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Hypertension; Telemonitoring; Blood Pressure; Post-Partum
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Hypertension; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: 2020-0175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All women will receive a de-identified laminated notecard that has their study results (Type of hypertensive pregnancy, gestational age at delivery, discharged and current blood pressure medication, last study blood pressure, and readmission status) on it that can be shared with any new provider (including non-obstetrical). As stated in the study consent, a letter outlining the same information will also be sent to the obstetrician listed in the patient's medical record
• IPD Sharing Time Frame: Within 7 days of study completion each participant will receive their personal data as outlined in the study consent.
• IPD Sharing Access Criteria: Each patient will be mailed their information.
• IPD Sharing Supporting Information Type: Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No