Clinical trial NCT06912776: Novel Visual Education Tool to Improve Recognition and Reporting of Postpartum Urgent Maternal Warning Signs
Official title: Novel Visual Education Tool to Improve Recognition and Reporting of Postpartum Urgent Maternal Warning Signs
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postpartum
Keywords: Pregnancy
Postpartum
nulliparus
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of participants who recognize deep vein thrombosis,
timeFrame: 1 Day
Secondary outcomes:
measure: Number of participants who demonstrate understanding deep vein thrombosis,
timeFrame: 1 Day
measure: Number of participants who would report deep vein thrombosis
timeFrame: 1 Day
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: Kaitlyn Neumann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Burger G. SOAP Newsletter. 1998;Winter:6-9
citation: Council on Patient Safety in Women's Health Care. Urgent Maternal Warning Signs. May 2020, <https://safehealthcareforeverywoman.org>.