Skip to main content
OpenTrials
Completed

NCT Number: NCT04570124

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension in Pregnancy Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of MS Medical Center

Jackson, Mississippi, 39216, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Does not meet Inclusion criteria
  • 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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Mississippi Medical Center

Other

Collaborators

  • University of Chicago

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Sep 30, 2020
Registry last updated
Dec 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.