Novel Visual Education Tool to Improve Recognition and Reporting of Postpartum Urgent Maternal Warning Signs

This study aims to create a novel visual education tool that builds on the urgent maternal warning signs identified by The Council on Patient Safety in Women's Health Care. Including effective images will improve the understanding of these grave warning signs/symptoms, improving anatomical accuracy while remaining simplistic for patients of varying levels of health care literacy. The investigative team will be focusing on urgent warning signs pertinent to the postpartum period.

Study Overview

• Status: Recruiting
• Conditions: Postpartum
• Intervention / Treatment: Other: Participant will view a visual aid picture (appendix A) first; Other: Participant will view a visual aid picture (appendix B) first

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paul C Fitzgerald, RN,BSN,MS; Phone Number: 3126951064; Email: p-fitzgerald2@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60614
      • Recruiting
      • Northwestern Medicine
      • Contact: Pauli C Fitzgerald, RN,BSN,MS; Phone Number: 3126951064; Email: p-fitzgerald2@northwestern.edu
      • Principal Investigator: Kaitlyn Neumann, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Postpartum women
• Nulliparity
• Age >18 years of age
• English speaking patients

Exclusion Criteria:

• Inability to provide informed written consent
• Refusal to participate in all study-related procedures
• Patients not fluent in English
• Patients with current or history of serious peripartum complications and/or events - such as DVT, PE, peripartum cardiomyopathy, etc. (in which the patient may have received more than standard clinical counseling)
• Patient with comorbidities that potentially require anticoagulation i.e. coagulopathies and may be more prone to DVTs
• Patients with uncorrected visual or hearing impairment
• Healthcare providers (in which patients will have significant background knowledge)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Participant will view a visual aid picture (appendix A) first; Participant will view a visual aid picture (appendix A) of a post delivery complication first.	Other: Participant will view a visual aid picture (appendix A) first; Participant will view a visual aid picture (appendix A) of a post delivery complication first
Other: Participant will view a visual aid picture (appendix B) first; Participant will view a visual aid picture (appendix B) of a post delivery complication first	Other: Participant will view a visual aid picture (appendix B) first; Participant will view a visual aid picture (appendix B) of a post delivery complication first

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who recognize deep vein thrombosis,	Participant will accurately identify the health care issue shown to participants and identified as Picture A and Picture B	1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who demonstrate understanding deep vein thrombosis,	Participants written response of the understanding of deep vein thrombosis.	1 Day
Number of participants who would report deep vein thrombosis	After review of Picture A and Picture B number of participants who report deep vein thrombosis to their care provider or emergency room.	1 Day

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Kaitlyn Neumann, MD, Northwestern University

Publications and helpful links

General Publications

• You WB, Wolf MS, Bailey SC, Grobman WA. Improving patient understanding of preeclampsia: a randomized controlled trial. Am J Obstet Gynecol. 2012 May;206(5):431.e1-5. doi: 10.1016/j.ajog.2012.03.006. Epub 2012 Mar 13.
• Delp C, Jones J. Communicating information to patients: the use of cartoon illustrations to improve comprehension of instructions. Acad Emerg Med. 1996 Mar;3(3):264-70. doi: 10.1111/j.1553-2712.1996.tb03431.x.
• Houts PS, Bachrach R, Witmer JT, Tringali CA, Bucher JA, Localio RA. Using pictographs to enhance recall of spoken medical instructions. Patient Educ Couns. 1998 Oct;35(2):83-8. doi: 10.1016/s0738-3991(98)00065-2.
• Burger G. SOAP Newsletter. 1998;Winter:6-9
• Council on Patient Safety in Women's Health Care. Urgent Maternal Warning Signs. May 2020, <https://safehealthcareforeverywoman.org>.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: March 27, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 6, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Pregnancy; Postpartum; nulliparus
• Other Study ID Numbers: STU00222375

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No