Postpartum Video Education in High Risk Populations

NCT06310720 | Suspended DMC

• 1 other identifier: 23-10026618
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-center, randomized control study to determine if video education at the time of postpartum discharge improves patient knowledge on the warning signs for the top three causes of severe maternal morbidity (infection, hemorrhage, and blood pressure disorders) in the first seven days following delivery for self-identified, Black, Latinx, other with two or more self-identified races, Medicaid, and/or uninsured postpartum individuals. Participants will be randomized to written discharge education + video education (intervention) vs standard discharge education (control). They will complete a baseline questionnaire and a post-discharge education questionnaire during their postpartum stay to assess for knowledge improvement. The investigators hypothesize that video education will improve patient's knowledge of severe maternal morbidity warning signs.

Conditions

Postpartum Hemorrhage; Postpartum Depression; Postpartum Sepsis; Postpartum Preeclampsia; Patient Empowerment; Patient Education; Postpartum Care

Outcome Measures

Primary Outcomes (1)

• Change in baseline and post-education questionnaire score

  Patients will complete a baseline and post-discharge education 15 item questionnaire that will assess knowledge on postpartum hemorrhage, infection, hypertensive disorders of pregnancy, and depression. The questionnaire will be scored 0-15 based on the number of correct responses. A lower score indicates lower knowledge, while a higher score indicates a better knowledge of the subject items. Outcome will be binary based on whether or not the patient improved their score between the two questionnaires.

  Baseline, post-discharge (up to one week)

Secondary Outcomes (6)

• Change in post-education and post-discharge questionnaire score

  3-7 days

• Number of participants who attended 6 week postpartum visit

  6 weeks

• Healthcare utilization: Number of clinic visits

  6 weeks

• Healthcare utilization: Number of phone calls

  6 weeks

• Healthcare utilization: Number of urgent care/emergency room visits

  6 weeks

Study Arms (2)

Written Discharge Education + Video Education

EXPERIMENTAL

These patients will view a 12-minute educational video on SMM warning signs, in addition to the written discharge instructions provided by nursing staff. At the completion of the video, they will complete a post-video questionnaire to assess their knowledge on the covered topics.

Other: Video Education

Written Discharge Education

NO INTERVENTION

They will receive the written discharge instructions provided by nursing staff and complete the post-discharge instruction questionnaire.

Interventions

Video Education OTHER

12-minute educational video covering postpartum topics of hemorrhage, infection, hypertension, and depression. Created by Cicatelli Associates Inc.

Written Discharge Education + Video Education

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Speaks English or Spanish
• Informed and written consent
• Delivered at WCM
• Received prenatal, and will receive postpartum, care through a WCM-affiliated obstetric and/or midwifery practice
• Self-identified as Black, Latinx, other and/or Medicaid or Uninsured

You may not qualify if:

• Patients who do not plan to receive postpartum care within the WCM system
• Patients who experience an intrauterine fetal demise
• Patients who speak a primary language other than English or Spanish

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Alexandra Cohen Hospital for Women and Newborns

New York, New York, 10065, United States

Location

Related Publications (11)

• Centers for Disease Control and Prevention. Pregnancy mortality surveillance system. Centers for Disease Control and Prevention, US Department of Health and Human Services; 2020. Accessed March 4, 2020. https://www.cdc.gov/reproductivehealth/maternal-mortality/pregnancy-mortality-surveillance-system.htm

  BACKGROUND

• Petersen EE, Davis NL, Goodman D, Cox S, Mayes N, Johnston E, Syverson C, Seed K, Shapiro-Mendoza CK, Callaghan WM, Barfield W. Vital Signs: Pregnancy-Related Deaths, United States, 2011-2015, and Strategies for Prevention, 13 States, 2013-2017. MMWR Morb Mortal Wkly Rep. 2019 May 10;68(18):423-429. doi: 10.15585/mmwr.mm6818e1.

  PMID: 31071074 BACKGROUND

• Centers for Disease Control and Prevention. (2019). Data Brief from 14 U.S. Maternal Mortality Review Committees, 2008-2017. Retrieved from https://www.cdc.gov/reproductivehealth/maternal-mortality/erase-mm/mmr-data-brief.html

  BACKGROUND

• Human Resources & Services Administration. (2019). Maternal Morbidity & Mortality. Retrieved from https://www.hrsa.gov/maternal-mortality/index.html#about)

  BACKGROUND

• Centers for Disease Control and Prevention. Severe Maternal Morbidity. Retrieved from https://www.cdc.gov/reproductivehealth/maternalinfanthealth/severematernalmorbidity.html

  BACKGROUND

• Review to action, CDC Foundation. Capacity to review and prevent maternal deaths. report from nine maternal mortality review committees. 2018. http://reviewtoaction.org/Reportfrom_Nine_MMRCs.

  BACKGROUND

• O'Dell, D. D., et al. (2019). A Quality Improvement Project- Standardizing Postpartum Discharge Instructions with an Educational Video. Obstetrics and Gynecology. Conference: 67th Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists. Nashville, TN United States 133(SUPPL 1).

  BACKGROUND

• O'Sullivan TA, Cooke J, McCafferty C, Giglia R. Online Video Instruction on Hand Expression of Colostrum in Pregnancy is an Effective Educational Tool. Nutrients. 2019 Apr 19;11(4):883. doi: 10.3390/nu11040883.

  PMID: 31010174 BACKGROUND

• Wisely CE, Robbins CB, Stinnett S, Kim T, Vann RR, Gupta PK. Impact of Preoperative Video Education for Cataract Surgery on Patient Learning Outcomes. Clin Ophthalmol. 2020 May 20;14:1365-1371. doi: 10.2147/OPTH.S248080. eCollection 2020.

  PMID: 32546944 BACKGROUND

• Che YJ, Gao YL, Jing J, Kuang Y, Zhang M. Effects of an Informational Video About Anesthesia on Pre- and Post-Elective Cesarean Section Anxiety and Recovery: A Randomized Controlled Trial. Med Sci Monit. 2020 Apr 8;26:e920428. doi: 10.12659/MSM.920428.

  PMID: 32265432 BACKGROUND

• Howell EA. Reducing Disparities in Severe Maternal Morbidity and Mortality. Clin Obstet Gynecol. 2018 Jun;61(2):387-399. doi: 10.1097/GRF.0000000000000349.

  PMID: 29346121 BACKGROUND

MeSH Terms

Conditions

Postpartum Hemorrhage; Depression, Postpartum; Puerperal Infection; Patient Participation

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders; Pregnancy Complications, Infectious; Infections; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Heather Lipkind, MD, MSce

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 15, 2024
• Study Start: May 9, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)