NCT06912776

Brief Summary

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.

Trial Health

77
On Track

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
3mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
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 Progress83%
Jun 2025Aug 2026

First Submitted

Initial submission to the registry

March 27, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

June 20, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

March 27, 2025

Last Update Submit

July 6, 2025

Conditions

Postpartum

Keywords

PregnancyPostpartumnulliparus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Number of participants who demonstrate understanding deep vein thrombosis,

    1 Day

  • Number of participants who would report deep vein thrombosis

    1 Day

Study Arms (2)

Participant will view a visual aid picture (appendix A) first

OTHER

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 B) first

OTHER

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

Interventions

Participant will view a visual aid picture (appendix A) firstOTHER

Participant will view a visual aid picture (appendix A) of a post delivery complication first

Participant will view a visual aid picture (appendix A) first
Participant will view a visual aid picture (appendix B) firstOTHER

Participant will view a visual aid picture (appendix B) of a post delivery complication first

Participant will view a visual aid picture (appendix B) first

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Medicine

Chicago, Illinois, 60614, United States

RECRUITING

Related Publications (5)

  • 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.

    PMID: 22542120BACKGROUND

  • 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.

    PMID: 8673784BACKGROUND

  • 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.

    PMID: 10026551BACKGROUND

  • Burger G. SOAP Newsletter. 1998;Winter:6-9

    BACKGROUND

  • Council on Patient Safety in Women's Health Care. Urgent Maternal Warning Signs. May 2020, <https://safehealthcareforeverywoman.org>.

    BACKGROUND

Study Officials

  • Kaitlyn Neumann, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul C Fitzgerald, RN,BSN,MS

CONTACT

3126951064p-fitzgerald2@northwestern.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 27, 2025

First Posted

April 6, 2025

Study Start

June 20, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

July 8, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)