Hypertension in PregnancyNCT04570124
STAMPP-HTN in a High-risk Rural Population of Women
A study testing Home Blood Pressure Telemonitoring in people with Hypertension in Pregnancy, run by University of Mississippi Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hypertension in Pregnancy
- What is being tested?
- Home Blood Pressure Telemonitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2020to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of MS Medical Center
Jackson, Mississippi, 39216
About this study
Official title: 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.
Read the 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
- Being tested
- Home Blood Pressure Telemonitoring
- Keywords
- Hypertension, Blood Pressure, Post-Partum, Telemonitoring
- Medical subject headings
- Hypertension, Pregnancy-Induced, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Blood Pressure TelemonitoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Home Blood Pressure Telemonitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start14 Dec 2020
- Primary completion30 Sep 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago
- Responsible party
- Principal investigator, Kedra Wallace, University of Mississippi Medical Center
- Investigators
- Kedra Wallace, PhD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570124
- Sponsor's protocol ID
- 2020-0175
- Status last verified
- Dec 2022
- First submitted
- 17 Sep 2020
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 38702619
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing the Systemic Treatment and Management of Postpartum Hypertension (STAMPP-HTN) Bundle in a High-risk Mississippi Population
- ClinicalTrials.gov ID
- NCT04570124
- Acronym / sponsor ID
- 2020-0175
- Conditions
- Hypertension in Pregnancy
- Keywords
- Hypertension, Blood Pressure, Post-Partum, Telemonitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Collaborators
- University of Chicago
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remote Surveillance | Experimental | Device: Home Blood Pressure TelemonitoringWomen 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Blood Pressure TelemonitoringWomen 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. | Device | Remote Surveillance |
Primary outcome
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.
2 secondary outcomes
Increase awareness and knowledge of postpartum blood pressure control in a group of high-risk women
Time frame: 9 months
Assess compliance using HBPT and adherence to blood pressure medication
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Derived from this study: PubMed 38702619Moustafa 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.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kedra Wallace, PhD principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Blood Pressure Telemonitoring in people with Hypertension in Pregnancy, run by University of Mississippi Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine if HBPT decreases the severity of postpartum hypertension complication (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04570124, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.