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

• ClinicalTrials.gov Identifier: NCT04570124
• Recruitment Status: Recruiting
• First Posted: September 30, 2020
• Last Update Posted: December 17, 2020
• Sponsor: University of Mississippi Medical Center
• Collaborator: University of Chicago
• Information provided by (Responsible Party): Kedra Wallace, University of Mississippi Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypertension in Pregnancy	Device: Home Blood Pressure Telemonitoring	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 211 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Implementing the Systemic Treatment and Management of Postpartum Hypertension (STAMPP-HTN) Bundle in a High-risk Mississippi Population
• Actual Study Start Date: December 14, 2020
• Estimated Primary Completion Date: September 2021
• Estimated Study Completion Date: January 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Determine if HBPT decreases the severity of postpartum hypertension complication [ Time Frame: 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 :

1. Increase awareness and knowledge of postpartum blood pressure control in a group of high-risk women [ Time Frame: 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.
2. Assess compliance using HBPT and adherence to blood pressure medication [ Time Frame: 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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Lucia I Solis, BS; (601) 613- 9984; lsolis@umc.edu

Contact: Shauna Spencer, MS, BS RN; (347)-845-9700; sspencer2@umc.edu

Locations

United States, Mississippi

University of MS Medical Center; Recruiting

Jackson, Mississippi, United States, 39216

Principal Investigator: Kedra L Wallace, PhD

Sponsors and Collaborators

University of Mississippi Medical Center

University of Chicago

Investigators

• Principal Investigator: Kedra Wallace, PhD; University of Mississippi Medical Center

More Information

• Responsible Party: Kedra Wallace, Associate Professor, PhD, University of Mississippi Medical Center
• ClinicalTrials.gov Identifier: NCT04570124
• Other Study ID Numbers: 2020-0175
• First Posted: September 30, 2020
• Last Update Posted: December 17, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: Within 7 days of study completion each participant will receive their personal data as outlined in the study consent.
• Access Criteria: Each patient will be mailed their information.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kedra Wallace, University of Mississippi Medical Center:

Hypertension; Blood Pressure; Post-Partum; Telemonitoring

Additional relevant MeSH terms:

Hypertension, Pregnancy-Induced; Hypertension; Vascular Diseases; Cardiovascular Diseases; Pregnancy Complications