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

NCT04570124 | Completed DMC

• 1 other identifier: 2020-0175
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension in Pregnancy

Keywords

Hypertension; Blood Pressure; Post-Partum; Telemonitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Increase awareness and knowledge of postpartum blood pressure control in a group of high-risk women

  9 months

• Assess compliance using HBPT and adherence to blood pressure medication

  9 months

Study Arms (1)

Remote Surveillance

EXPERIMENTAL

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

Interventions

Home Blood Pressure Telemonitoring 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.

Remote Surveillance

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent in a postpartum woman between 18-45 years of age at the time of study enrollment
• 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).
• Ability to understand English or Spanish
• Reliable access to the Internet and a Bluetooth mobile device
• Willingness to download Omron Connect App and ability to use blood pressure monitor

You may not qualify if:

• Postpartum or operative complication that prolongs hospital stay beyond postpartum day 10.
• Patients who are currently participating in another clinical trial to evaluate a therapeutic intervention for control of blood pressure.

Sponsors & Collaborators

• University of Mississippi Medical Center: lead
• University of Chicago: collaborator

Study Sites (1)

University of MS Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (1)

• 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.

  PMID: 38702619 DERIVED

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Hypertension

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kedra Wallace, PhD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, PhD

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 30, 2020
• Study Start: December 14, 2020
• Primary Completion: September 30, 2021
• Study Completion: April 30, 2022
• Last Updated: December 29, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)