NCT07807098

Brief 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 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
14mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Sep 2026Dec 2027

First Submitted

Initial submission to the registry

August 9, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

September 16, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

September 8, 2026

Status Verified

July 1, 2026

Enrollment Period

12 months

First QC Date

August 9, 2026

Last Update Submit

September 1, 2026

Conditions

Keywords

PreeclampsiaGestational HypertensionPostpartumPostpartum braceletBlood pressure cuffSelf-efficacySelf-management

Outcome Measures

Primary Outcomes (1)

  • 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.

    6-10 weeks

Secondary Outcomes (1)

  • Postpartum Bracelet Stimulates Self-Management Behaviors

    6-10 weeks

Other Outcomes (1)

  • In Hospital Preeclampsia Education on Self-Management

    6-10 weeks

Study Arms (1)

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.

Other: Education, Blood Pressure Cuff, and Visual Cue Bracelet

Interventions

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.

Also known as: At-Risk bracelet
Blood Pressure Cuff, At-Risk Postpartum Bracelet, and In Hospital Preeclampsia Education

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale only due to postpartum phase.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • A new diagnosis of GHTN or PE, who are discharged from FLC, and express willingness to participate in virtual interviews.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3(2), 77-101. https://doi.org/10.1191/1478088706qp063oa

    BACKGROUND
  • 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.

    PMID: 32627621BACKGROUND
  • Noble 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.

    PMID: 41496166BACKGROUND
  • Hoppe 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.

    PMID: 32439388BACKGROUND
  • Cilenti, 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

    BACKGROUND
  • 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.

    PMID: 38049716BACKGROUND

MeSH Terms

Conditions

Pre-EclampsiaHypertension, Pregnancy-Induced

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sr. Practitioner, Clinical Education & Professional Development-Nursing

Study Record Dates

First Submitted

August 9, 2026

First Posted

September 8, 2026

Study Start

September 16, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

September 8, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
3 months after completion of study publication and 5 years.
Access Criteria
Pending