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

NCT ID: NCT04570124

Last Updated: 2022-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-14
• Study Completion Date: 2022-04-30

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.

Conditions

Hypertension in Pregnancy

Keywords

Hypertension; Blood Pressure; Post-Partum; Telemonitoring

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Home Blood Pressure Telemonitoring

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: collaborator

University of Mississippi Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Kedra Wallace

Associate Professor, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kedra Wallace, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Mississippi Medical Center

Locations

University of MS Medical Center

Jackson, Mississippi, United States

Countries

United States

References

Moustafa ASZ, Yimer W, Perry A, Solis L, Belk S, Morris R, Spencer SK, Rana S, Wallace K. Report from a text-based blood pressure monitoring prospective cohort trial among postpartum women with hypertensive disorders of pregnancy. BMC Pregnancy Childbirth. 2024 May 3;24(1):340. doi: 10.1186/s12884-024-06511-1.

Reference Type: DERIVED

PMID: 38702619 (View on PubMed)

Other Identifiers

2020-0175

Identifier Type: -

Identifier Source: org_study_id