Novel Visual Education Tool to Improve Recognition and Reporting of Postpartum Urgent Maternal Warning Signs
June 9, 2026 updated by: Kaitlyn Neumann, Northwestern University
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
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Paul C Fitzgerald, RN,BSN,MS
- Phone Number: 3126951064
- Email: p-fitzgerald2@northwestern.edu
Study Locations
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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.
|
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
|
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,
Time Frame: 1 Day
|
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,
Time Frame: 1 Day
|
Participants written response of the understanding of deep vein thrombosis.
|
1 Day
|
|
Number of participants who would report deep vein thrombosis
Time Frame: 1 Day
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kaitlyn Neumann, MD, Northwestern University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 20, 2025
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
July 1, 2027
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 (Actual)
June 10, 2026
Last Update Submitted That Met QC Criteria
June 9, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.