NCT05159726

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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 8, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

July 5, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

December 8, 2021

Last Update Submit

January 30, 2023

Conditions

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, discharge (up to one week)

Secondary Outcomes (4)

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

    3-7 days

  • Compliance with Postpartum Care

    6 weeks

  • Healthcare utilization

    6 weeks

  • Patient satisfaction

    Baseline, post-education

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

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

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years
  • Speaks English or Spanish
  • Informed and written consent
  • Delivered at Yale New Haven Hospital (YNHH)
  • Received prenatal, and will receive postpartum, care through a YNHH-affiliated obstetric and/or midwifery practice

You may not qualify if:

  • Patients who do not plan to receive postpartum care within the YNHH system
  • Patients who experience an intrauterine fetal demise
  • Patients who have a pregnancy with multiple severe congenital anomalies with an anticipated poor prognosis
  • Patients who speak a primary language other than English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Related Publications (12)

  • 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: 31071074BACKGROUND
  • 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
  • Krantz, T. E., et al. (2015). Computer graphic animation for intrauterine device contraceptive counseling in postpartum patients. Obstetrics and Gynecology 125: 68S.

    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: 31010174BACKGROUND
  • 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: 32546944BACKGROUND
  • 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: 32265432BACKGROUND
  • White KJ, Tortal D, Callahan K, Eng K, Hyland M, Underwood E, Senter L, Leon-Martinez D, Son M, Lipkind H. Using a Patient Educational Video to Improve Knowledge of Maternal Mortality Warning Signs: A Randomized Controlled Trial. Obstet Gynecol. 2023 Nov 1;142(5):1139-1147. doi: 10.1097/AOG.0000000000005368. Epub 2023 Sep 13.

MeSH Terms

Conditions

Postpartum HemorrhagePuerperal InfectionDepression, PostpartumPatient Participation

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPregnancy Complications, InfectiousInfectionsDepressive DisorderMood DisordersMental DisordersPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Heather Lipkind, MD, MPH

    Yale 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

December 8, 2021

First Posted

December 16, 2021

Study Start

July 5, 2022

Primary Completion

August 20, 2022

Study Completion

December 31, 2022

Last Updated

February 1, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations