PostpartumNCT06912776
Novel Visual Education Tool to Improve Recognition and Reporting of Postpartum Urgent Maternal Warning Signs
A study testing Participant will view a visual aid picture (appendix A) first and Participant will view a visual aid picture (appendix B) first in people with Postpartum, run by Northwestern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum
- What is being tested?
- Participant will view a visual aid picture (appendix A) first and Participant will view a visual aid picture (appendix B) first
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postpartum women
- Nulliparity
- Age >18 years of age
- English speaking patients
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern Medicine
Chicago, Illinois, 60614
Pauli C Fitzgerald, RN,BSN,MS, 3126951064, p-fitzgerald2@northwestern.edu
Kaitlyn Neumann, MD
About this study
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.
- Conditions
- Postpartum
- Being tested
- Participant will view a visual aid picture (appendix A) first, Participant will view a visual aid picture (appendix B) first
- Keywords
- Pregnancy, Postpartum, nulliparus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 B) firstOther
Participant will view a visual aid picture (appendix B) of a post delivery complication first
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Participant will view a visual aid picture (appendix B) first |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 Day
Secondary outcomes (2)
Number of participants who demonstrate understanding deep vein thrombosis,
Participants written response of the understanding of deep vein thrombosis.
Measured: 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.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start20 Jun 2025
- Primary completionMay 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PostpartumStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaitlyn Neumann, Northwestern University
- Investigators
- Kaitlyn Neumann, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912776
- Sponsor's protocol ID
- STU00222375
- Status last verified
- Jun 2026
- First submitted
- 27 Mar 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22542120Delp 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.
PubMed 8673784Houts 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.
PubMed 10026551Burger 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 at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Visual Education Tool to Improve Recognition and Reporting of Postpartum Urgent Maternal Warning Signs
- ClinicalTrials.gov ID
- NCT06912776
- Acronym / sponsor ID
- STU00222375
- Conditions
- Postpartum
- Keywords
- Pregnancy, Postpartum, nulliparus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participant will view a visual aid picture (appendix A) first | Other | Other: Participant will view a visual aid picture (appendix A) firstParticipant will view a visual aid picture (appendix A) of a post delivery complication first. |
| Participant will view a visual aid picture (appendix B) first | Other | Other: Participant will view a visual aid picture (appendix B) firstParticipant will view a visual aid picture (appendix B) of a post delivery complication first |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Postpartum women
- Nulliparity
- Age >18 years of age
- English speaking patients
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participant will view a visual aid picture (appendix A) firstParticipant 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) firstParticipant 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 |
Primary outcome
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
2 secondary outcomes
Number of participants who demonstrate understanding deep vein thrombosis,
Time frame: 1 Day
Number of participants who would report deep vein thrombosis
Time frame: 1 Day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Background: PubMed 22542120You 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.
- Background: PubMed 8673784Delp 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.
- Background: PubMed 10026551Houts 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.
- BackgroundBurger G. SOAP Newsletter. 1998;Winter:6-9
- BackgroundCouncil on Patient Safety in Women's Health Care. Urgent Maternal Warning Signs. May 2020, <https://safehealthcareforeverywoman.org>.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kaitlyn Neumann, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participant will view a visual aid picture (appendix A) first and Participant will view a visual aid picture (appendix B) first in people with Postpartum, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul C Fitzgerald, RN,BSN,MS (3126951064, p-fitzgerald2@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who recognize deep vein thrombosis, (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06912776, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026; AzTrials last refreshed its copy on 3 Nov 2026.