Monitoring Blood PressureNCT07491510
Improving Prenatal Care to Reduce Early Onset Preeclampsia in Low-Income
A study testing Active Comparator: Behavioral: Experimental: Centering HER (routine prenatal care + 7 doula-led 90-minute virtual group in people with Monitoring Blood Pressure and Aspirin Prophylaxis, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if a telehealth hypertension group prenatal care program (Centering HER / HGPC-T) can improve blood pressure monitoring and aspirin adherence and help reduce early-onset preeclampsia in low-income, predominantly Black pregnant participants in Kansas who are <13 weeks… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Monitoring Blood Pressure, Aspirin Prophylaxis
- What is being tested?
- Active Comparator: Behavioral: Experimental: Centering HER (routine prenatal care + 7 doula-led 90-minute virtual group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- English or Spanish speaking
- <13 weeks gestations
- >18 years old
- moderate or high risk for hypertensive disorders in pregnancy
Who cannot join
- less than18 years of age
- not receiving prenatal care
- not eligible for doula care
- no risk factors for hypertensive disorders in pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66101
About this study
Official title: Improving Prenatal Care to Reduce Early Onset Preeclampsia in Low-Income Black Women in Kansas
The goal of this clinical trial is to learn if a telehealth hypertension group prenatal care program (Centering HER / HGPC-T) can improve blood pressure monitoring and aspirin adherence and help reduce early-onset preeclampsia in low-income, predominantly Black pregnant participants in Kansas who are <13 weeks gestation, age ≥18, and moderate or high risk for preeclampsia (USPSTF).
The main question[s] it aims to answer [is/are]:
Does Centering HER increase hypertension monitoring and aspirin compliance compared with usual doula care?
Is Centering HER feasible and acceptable, and what contextual factors influence implementation in community clinics?
Read the detailed description
The study will compare Centering HER (routine prenatal care + 7 doula-led 90-minute virtual group sessions with OB/GYN fellow oversight + Bluetooth BP cuff/scale ± Apple Watch) to usual doula care + routine prenatal care to see if the intervention improves monitoring/adherence and supports better BP-related outcomes.
Participants will:
- Be randomized 2:1 to Centering HER or usual doula care.
- Complete REDCap surveys at baseline, antepartum, and postpartum.
- If assigned to Centering HER, attend 7 virtual group sessions and self-monitor/report BP and weight using a Bluetooth BP cuff/scale (± Apple Watch), and keep a medication log if applicable.
- Conditions
- Monitoring Blood Pressure, Aspirin Prophylaxis
- Being tested
- Active Comparator: Behavioral: Experimental: Centering HER (routine prenatal care + 7 doula-led 90-minute virtual group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator: Behavioral: Experimental: Centering HER (routine prenatal care + 7 doula-led 90-minute virtual groupBehavioural
routine prenatal care + 7 doula-led 90-minute virtual group sessions with OB/GYN fellow oversight + Bluetooth BP cuff/scale ± Apple Watch
| Study group | Role | What they receive |
|---|---|---|
| usual doula care + routine prenatal care | Placebo comparator | Not described Receives: Behavioral: Active Comparator: Behavioral: Experimental: Centering HER (routine prenatal care + 7 doula-led 90-minute virtual group |
| Behavioral: Experimental: Centering HER (routine prenatal care + 7 doula-led 90-minute virtual group | Active comparator | routine prenatal care + 7 doula-led 90-minute virtual group sessions with OB/GYN fellow oversight + Bluetooth BP cuff/scale ± Apple Watch Receives: Behavioral: Active Comparator: Behavioral: Experimental: Centering HER (routine prenatal care + 7 doula-led 90-minute virtual group |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean diastolic blood pressure
Average daily diastolic blood pressure
Measured: From enrollment to the end of treatment at 12 weeks
mean systolic blood pressure
Average daily systolic blood pressure
Measured: From enrollment of study to end of treatment at 12 weeks
Secondary outcomes (2)
aspirin use
Aspirin use or not
Measured: From enrollment to the end of treatment at 12 weeks
implementation outcomes
Number of intervention sessions attended
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start2 Mar 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monitoring Blood PressureStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- * Be randomized 2:1 to Centering HER or usual doula care. * Complete REDCap surveys at baseline, antepartum, and postpartum. * If assigned to Centering HER, attend 7 virtual group sessions and self-monitor/report BP and weight using a Bluetooth BP cuff/scale (± Apple Watch), and keep a medication log if applicable.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491510
- Sponsor's protocol ID
- STUDY00160319
- Other IDs
- 1P20GM139733
- Status last verified
- Aug 2026
- First submitted
- 30 Jan 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will not be shared with other researchers outside of the study team to date. Currently the decision is undecided unless IRB approved to share with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Prenatal Care to Reduce Early Onset Preeclampsia in Low-Income Black Women in Kansas
- ClinicalTrials.gov ID
- NCT07491510
- Acronym / sponsor ID
- STUDY00160319
- Conditions
- Monitoring Blood Pressure, Aspirin Prophylaxis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 24 Mar 2026 (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 goal of this clinical trial is to learn if a telehealth hypertension group prenatal care program (Centering HER / HGPC-T) can improve blood pressure monitoring and aspirin adherence and help reduce early-onset preeclampsia in low-income, predominantly Black pregnant participants in Kansas who are <13 weeks gestation, age ≥18, and moderate or high risk for preeclampsia (USPSTF).
The main question[s] it aims to answer [is/are]:
Does Centering HER increase hypertension monitoring and aspirin compliance compared with usual doula care?
Is Centering HER feasible and acceptable, and what contextual factors influence implementation in community clinics?
Detailed description
The study will compare Centering HER (routine prenatal care + 7 doula-led 90-minute virtual group sessions with OB/GYN fellow oversight + Bluetooth BP cuff/scale ± Apple Watch) to usual doula care + routine prenatal care to see if the intervention improves monitoring/adherence and supports better BP-related outcomes.
Participants will:
- Be randomized 2:1 to Centering HER or usual doula care.
- Complete REDCap surveys at baseline, antepartum, and postpartum.
- If assigned to Centering HER, attend 7 virtual group sessions and self-monitor/report BP and weight using a Bluetooth BP cuff/scale (± Apple Watch), and keep a medication log if applicable.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- * Be randomized 2:1 to Centering HER or usual doula care. * Complete REDCap surveys at baseline, antepartum, and postpartum. * If assigned to Centering HER, attend 7 virtual group sessions and self-monitor/report BP and weight using a Bluetooth BP cuff/scale (± Apple Watch), and keep a medication log if applicable.
| Arm | Type | Receives |
|---|---|---|
| usual doula care + routine prenatal care | Placebo comparator | Behavioral: Active Comparator: Behavioral: Experimental: Centering HER (routine prenatal care + 7 doula-led 90-minute virtual group |
| Behavioral: Experimental: Centering HER (routine prenatal care + 7 doula-led 90-minute virtual group | Active comparator | Behavioral: Active Comparator: Behavioral: Experimental: Centering HER (routine prenatal care + 7 doula-led 90-minute virtual grouproutine prenatal care + 7 doula-led 90-minute virtual group sessions with OB/GYN fellow oversight + Bluetooth BP cuff/scale ± Apple Watch |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- English or Spanish speaking
- <13 weeks gestations
- >18 years old
- moderate or high risk for hypertensive disorders in pregnancy
Key exclusion criteria (4 listed)
- less than18 years of age
- not receiving prenatal care
- not eligible for doula care
- no risk factors for hypertensive disorders in pregnancy
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 |
|---|---|---|
| Active Comparator: Behavioral: Experimental: Centering HER (routine prenatal care + 7 doula-led 90-minute virtual grouproutine prenatal care + 7 doula-led 90-minute virtual group sessions with OB/GYN fellow oversight + Bluetooth BP cuff/scale ± Apple Watch | Behavioural | Behavioral: Experimental: Centering HER (routine prenatal care + 7 doula-led 90-minute virtual group, usual doula care + routine prenatal care |
Primary outcome
mean diastolic blood pressure
Time frame: From enrollment to the end of treatment at 12 weeks
Average daily diastolic blood pressure
mean systolic blood pressure
Time frame: From enrollment of study to end of treatment at 12 weeks
Average daily systolic blood pressure
2 secondary outcomes
aspirin use
Time frame: From enrollment to the end of treatment at 12 weeks
implementation outcomes
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No. The IPD will not be shared with other researchers outside of the study team to date. Currently the decision is undecided unless IRB approved to share with other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator: Behavioral: Experimental: Centering HER (routine prenatal care + 7 doula-led 90-minute virtual group in people with Monitoring Blood Pressure and Aspirin Prophylaxis, run by University of Kansas 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 4 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 14 Aug 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
mean diastolic blood pressure (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2026.