PreeclampsiaNCT07807098
Exploring the Effect of Discharge Education, Blood Pressure Cuffs, and Postpartum Bracelets to Improve Health Among Newly Diagnosed Gestational Hypertension and Preeclampsia Patients During the Postpartum Period.
A study testing Education, Blood Pressure Cuff, and Visual Cue Bracelet in people with Preeclampsia and Gestational Hypertension, run by Memorial Hermann Health System.
Trial summary
This pilot, exploratory qualitative, descriptive study will examine whether standard postpartum discharge education, a free home blood pressure cuff, and an "At-Risk Postpartum" bracelet support self-management among postpartum patients newly diagnosed with preeclampsia or gestational hypertension at Memorial Hermann… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Preeclampsia, Gestational Hypertension, Postpartum
- What is being tested?
- Education, Blood Pressure Cuff, and Visual Cue Bracelet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 16 Sep 2026to Dec 2027
- Phase
- Interventional
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -A new diagnosis of GHTN or PE, who are discharged from FLC, and express willingness to participate in virtual interviews.
Who cannot join
- Patients with a preexisting diagnosis of chronic hypertension or PE, or are currently on antihypertensive medications (as these factors may influence self-management behaviors and outcomes).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This pilot, exploratory qualitative, descriptive study will examine whether standard postpartum discharge education, a free home blood pressure cuff, and an "At-Risk Postpartum" bracelet support self-management among postpartum patients newly diagnosed with preeclampsia or gestational hypertension at Memorial Hermann Memorial City Medical Center. Up to 40 eligible patients will receive standard postpartum education supplemented with blood pressure monitoring instruction, the Preeclampsia Foundation's blood pressure guidance sheet, and a bracelet intended to serve as a visual reminder of postpartum risk. Participants will complete virtual interviews at 6 and 10 weeks post-discharge to assess home blood pressure monitoring, knowledge retention, perceived usefulness of the bracelet, self-advocacy, and barriers to following recommended self-management behaviors. Findings will help determine whether these low-burden educational and practical tools can improve postpartum awareness, engagement, and safety, and will inform the design of a larger future study.
Read the detailed description
This pilot, exploratory qualitative, descriptive study will evaluate whether standard postpartum discharge education, a free home blood pressure cuff, and an "At-Risk Postpartum" bracelet support self-management among postpartum patients newly diagnosed with preeclampsia or gestational hypertension at Memorial Hermann Memorial City Medical Center. Eligible participants will be postpartum patients admitted to the Family Life Center who receive a newly diagnosis during hospitalization and were not previously taking antihypertensive medications.
The intervention supplements standard discharge education with blood pressure monitoring instruction, a no-cost BP cuff, written guidance from the Preeclampsia Foundation, and a bracelet intended to serve as a visual reminder of postpartum risk. After verbal informed consent, participants will complete virtual semi-structured interviews at approximately 6 and 10 weeks post-discharge to discuss BP monitoring, knowledge retention, bracelet usefulness, self-advocacy, and barriers to recommended self-management behaviors.
The primary outcome is evidence of home blood pressure self-management, including twice-daily monitoring. Additional areas of interest include maternal knowledge, perceived value of the bracelet, retention of preeclampsia signs and symptoms, and barriers to follow-through. Interview data will be analyzed using inductive thematic analysis, with descriptive statistics used to summarize participant demographics. Findings will inform future postpartum education strategies and a larger study aimed at improving safety and reducing preventable complications related to hypertensive disorders of pregnancy.
- Conditions
- Preeclampsia, Gestational Hypertension, Postpartum
- Being tested
- Education, Blood Pressure Cuff, and Visual Cue Bracelet
- Keywords
- Preeclampsia, Gestational Hypertension, Postpartum, Postpartum bracelet, Blood pressure cuff, Self-efficacy, Self-management
- Medical subject headings
- Pre-Eclampsia, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education, Blood Pressure Cuff, and Visual Cue BraceletOther
Also called At-Risk bracelet
In Family Life Center the intervention will be to provide standard education, at-risk bracelet, and BP cuff on discharge day. We are combining these practical tools to enhance self-management, knowledge, and engagement.
| Study group | Role | What they receive |
|---|---|---|
| Blood Pressure Cuff, At-Risk Postpartum Bracelet, and In Hospital Preeclampsia Education | Other | This descriptive qualitative study has only one arm receiving hospital approve standardized discharge education, blood pressure cuff, and an at-risk bracelet. Outcomes related to self-management behaviors will be measured through recorded interviews at 6- and 10-week intervals. Receives: Other: Education, Blood Pressure Cuff, and Visual Cue Bracelet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of Blood Pressure Self-Management
The primary outcome measure assesses whether the intervention supports postpartum blood pressure self-management among participants newly diagnosed with gestational hypertension or preeclampsia. This outcome is evaluated through the 6-week and 10-week semi-structured interview by asking participants if they are using tools to measure their blood pressure, and what action they are taking to manage their blood pressure and what barriers they face.
Measured: 6-10 weeks
Secondary outcomes (1)
Postpartum Bracelet Stimulates Self-Management Behaviors
The secondary outcome measure evaluates whether the "At-Risk Postpartum" bracelet serves as a visual reminder that reinforces self-management of preeclampsia and gestational hypertension. The semi-structure interviews address this outcome by asking participants at 6 and 10 weeks whether they wear the postpartum bracelet, why or why not, what value the bracelet adds if they wear it, and whether something else inspires them to take care of themselves if they do not wear it.
Measured: 6-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start16 Sep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study uses a single-site, qualitative descriptive model to examine how standard postpartum education, home blood pressure monitoring, and a visual risk reminder may influence self-management among patients newly diagnosed with gestational hypertension or preeclampsia. The model assumes that combining clear discharge education with practical monitoring tools and a visible reminder will increase patient awareness, reinforce the importance of blood pressure monitoring, and support timely self-advocacy after discharge.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Hermann Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veronica Zayas, Memorial Hermann Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807098
- Sponsor's protocol ID
- HSC-SN-25-0783
- Status last verified
- Jul 2026
- First submitted
- 9 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data supporting published findings may be shared after publication to support transparency, reproducibility, and privacy protection. Shared date may include deidentified virtual interview recordings. Requests should be sent to the corresponding author or principal investigator.
Publications
Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3(2), 77-101. https://doi.org/10.1191/1478088706qp063oa
Strassberg ER, Fisher S, Mackeen AD, Sun H, Paglia MJ. Comparison of different methods of patient education on preeclampsia: a randomized controlled trial. J Matern Fetal Neonatal Med. 2022 Jul;35(13):2507-2511. doi: 10.1080/14767058.2020.1786524. Epub 2020 Jul 6.
PubMed 32627621Noble J, Harper KD, Mitchell K, McClain EK. "I Gave Birth"-An Initiative to Improve Postpartum Care. N C Med J. 2023 Jan;84(1):24-27. doi: 10.18043/001c.67788.
PubMed 41496166Hoppe KK, Thomas N, Zernick M, Zella JB, Havighurst T, Kim K, Williams M, Niu B, Lohr A, Johnson HM. Telehealth with remote blood pressure monitoring compared with standard care for postpartum hypertension. Am J Obstet Gynecol. 2020 Oct;223(4):585-588. doi: 10.1016/j.ajog.2020.05.027. Epub 2020 May 19. No abstract available.
PubMed 32439388Cilenti, D., Jackson, A., Hernandez, N.D., Yates, L., Verbiest, S., Michener, J.L., & Castrucci, B.C. (2024). The Practical Playbook III: Working Together to Improve Maternal Health. Oxford University Press. (pp. 379-389). doi:10.1093/oso/9780197662984.001.0001. [https://books.google.com/books?hl=en&lr=&id=Dp_sEAAAQBAJ&oi=fnd&pg=PA379& dq=postpartum+bracelets&ots=N4Hy0uDmWs&sig=2J5l5j4uzQwbmpq8TUZziN6Hcu8#v =onepage&q&f=false
Arntzen E, Josendal R, Sandsaeter HL, Horn J. Postpartum follow-up of women with preeclampsia: facilitators and barriers - A qualitative study. BMC Pregnancy Childbirth. 2023 Dec 4;23(1):833. doi: 10.1186/s12884-023-06146-8.
PubMed 38049716