NCT06073054

Brief Summary

The goal of this clinical trial is to learn if a research pharmacist can improve the health of new mothers and their babies. The main questions it aims to answer are:

  • Will postpartum women who had elevated blood pressure during pregnancy be willing to participate in the study, talk to a pharmacist about their health and the health of their child, and text us their blood pressure measurements?
  • Will contact with the pharmacist improve the health of the mother and/or the child? Participants will:
  • complete a baseline demographic survey,
  • be given a blood pressure cuff and taught how to use it,
  • be asked to text us their blood pressure values 2 times per day for 7 days after enrollment,
  • complete a phone call with a pharmacist discussing their health and the health of their baby,
  • text us their blood pressure 1 time per day for 3 days 1 month after enrollment,
  • have a 1 month follow-up phone call with the research pharmacist, and
  • complete an exit survey to provide feedback about the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 22, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

January 30, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 29, 2025

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

September 22, 2023

Results QC Date

July 25, 2025

Last Update Submit

August 11, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Number of Participants Who Talk to Research Pharmacist

    We will calculate the number of participants who talk to the research pharmacist during the course of the intervention.

    Through study completion, an average of 30 days

  • Number of Participants Who Return BP Measurements

    We will calculate the number of participants who return at least one blood pressure measurement via text message.

    Through study completion, an average of 30 days

  • Percentage of Well-Child Visits Attended

    We will calculate the percentage of well-child visits that are attended by each family.

    Through study completion, an average of 30 days

  • Percentage of Vaccinations Received

    We will calculate the percentage of vaccinations received by each child.

    Through study completion, an average of 30 days

Secondary Outcomes (3)

  • Number of BP Measurements Submitted

    Through study completion, an average of 30 days

  • Blood Pressure Control

    Through study completion, an average of 30 days

  • Number of Participants Satisfied With the Study

    Through study completion, an average of 30 days

Study Arms (1)

Research Pharmacist Monitoring

EXPERIMENTAL

The pharmacist will help the mother find a primary care physician if she doesn't have one, obtain health insurance if she doesn't have any, and discuss any health-related information about herself or her child, as needed. These pharmacist interactions will occur 7 days after baseline and again 1 month later (the participant will be asked to measure and text their blood pressure again 1 time per day for 3 days during the follow-up month). If the participant's blood pressures become elevated, the pharmacist will provide behavioral and lifestyle interventions to attempt to lower the blood pressure. They may also recommend medications to the participant's physician. The pharmacist will have access to the participant's electronic medical record to obtain any blood pressure-related medications that the mother is prescribed as well as throughout the follow up to ensure any health-related conditions can be discussed, as necessary.

Behavioral: Research Pharmacist

Interventions

The goal of this intervention is to determine if contact with the research pharmacist will improve the health of the mother and/or child.

Research Pharmacist Monitoring

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • biological mother of a baby attending a 1-week to 6-month well-child visit,
  • received prenatal care at University of Iowa Hospitals and Clinics,
  • had at least 2 elevated blood pressures (\>= 130 mmHg systolic or \>= 80 mmHg diastolic) during pregnancy,
  • owns a smartphone

You may not qualify if:

  • arm circumference \> 17 inches,
  • prisoner status
  • unable to provide own written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Linnea Polgreen
Organization
University of Iowa

Study Officials

  • Hao Tran, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

September 22, 2023

First Posted

October 10, 2023

Study Start

January 30, 2024

Primary Completion

July 10, 2024

Study Completion

July 10, 2024

Last Updated

August 29, 2025

Results First Posted

August 29, 2025

Record last verified: 2025-08

Locations