NCT07009106

Brief Summary

Each year in the United States, about 700 people die from pregnancy-related causes. More than half of these deaths occur after delivery, during what is often called the "fourth trimester." Many of these deaths-up to 80%-are believed to be preventable. In the first week postpartum, the most common causes of death are heavy bleeding, high blood pressure, and infection. After the first week, heart problems such as cardiomyopathy are the leading causes of death. In addition to the risk of life-threatening complications, health issues like diabetes and high blood pressure during pregnancy can increase a person's risk of developing long-term conditions such as heart disease and type 2 diabetes. Despite the importance of postpartum care, up to 40% of individuals do not attend their postpartum check-up. Attendance is especially low among people who are younger, publicly insured, or from underserved communities. Among individuals with diabetes in pregnancy, postpartum care is critical to monitor blood sugar levels, assess for type 2 diabetes, manage complications, and ensure long-term follow-up with a primary care provider. However, many do not attend this visit or receive recommended screenings. Common reasons include feeling fine, time constraints, and a lack of understanding about the purpose of the visit. The study was conducted as a pilot randomized controlled trial at a tertiary care center among pregnant individuals with type 1, type 2, or gestational diabetes. Participants were randomly assigned to receive either usual care or to watch a 3-minute animated video during a prenatal visit. After enrolling, all participants completed a baseline survey using a secure platform (REDCap) assessing their knowledge about the postpartum period and care expectations. The video was available in English and Spanish and covered key information about what to expect after delivery, warning signs for complications, and why postpartum care is important. Immediately after viewing the video, participants in the intervention group repeated the knowledge-based questions to assess changes in their understanding. Investigators reviewed the electronic medical records to assess postpartum visit scheduling and attendance. This study is designed to determine whether a brief, accessible educational video can improve postpartum care engagement among individuals with diabetes in pregnancy. If effective, this type of video intervention could be implemented more widely to improve maternal health outcomes, particularly in high-risk populations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

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

Study Start

First participant enrolled

August 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 6, 2025

Completed
Last Updated

June 6, 2025

Status Verified

May 1, 2025

Enrollment Period

10 months

First QC Date

May 29, 2025

Last Update Submit

May 29, 2025

Conditions

Keywords

DiabetesVideo education

Outcome Measures

Primary Outcomes (2)

  • Change in baseline postpartum care knowledge after video education intervention

    Among participants randomized to the video intervention group, change in postpartum care knowledge will be assessed using a structured multiple-choice questionnaire administered before and immediately after viewing the educational video on a secure platform (REDCap). Knowledge questions assess understanding of postpartum expectations, complications, and importance of postpartum care. Improvement will be measured by comparing total scores on the pre- and post-video surveys.

    From pre-video survey during enrollment to immediately after video intervention (1-2 weeks later)

  • Rate of attendance to the postpartum visit

    The rate of attendance to a postpartum visit within 12 weeks after delivery will be assessed and compared between groups (video vs. usual care), as documented in the electronic medical record. Attendance will be defined as in-person or telehealth contact with an obstetric provider or primary care provider focused on postpartum care. Differences between groups will be compared using Fisher's exact test.

    12 weeks after delivery

Study Arms (2)

Control Group

NO INTERVENTION

Participants received standard prenatal care

Video Intervention

EXPERIMENTAL

Participants watched a short educational video on postpartum care during a regularly scheduled prenatal visit

Other: Educational video on postpartum care

Interventions

Participants watched a short educational video on postpartum care during a regularly scheduled prenatal visit.

Video Intervention

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of Type 1 Diabetes, Type 2 Diabetes, or gestational diabetes
  • weeks gestational age or later
  • years of age
  • English or Spanish speaking

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obstetrics & Gynecology Center (OGCC)

Providence, Rhode Island, 02905, United States

Location

Related Publications (11)

  • Ko JY, Rockhill KM, Tong VT, Morrow B, Farr SL. Trends in Postpartum Depressive Symptoms - 27 States, 2004, 2008, and 2012. MMWR Morb Mortal Wkly Rep. 2017 Feb 17;66(6):153-158. doi: 10.15585/mmwr.mm6606a1.

    PMID: 28207685BACKGROUND
  • Kim C, Newton KM, Knopp RH. Gestational diabetes and the incidence of type 2 diabetes: a systematic review. Diabetes Care. 2002 Oct;25(10):1862-8. doi: 10.2337/diacare.25.10.1862.

    PMID: 12351492BACKGROUND
  • Thiel de Bocanegra H, Braughton M, Bradsberry M, Howell M, Logan J, Schwarz EB. Racial and ethnic disparities in postpartum care and contraception in California's Medicaid program. Am J Obstet Gynecol. 2017 Jul;217(1):47.e1-47.e7. doi: 10.1016/j.ajog.2017.02.040. Epub 2017 Mar 3.

    PMID: 28263752BACKGROUND
  • Attanasio LB, Ranchoff BL, Cooper MI, Geissler KH. Postpartum Visit Attendance in the United States: A Systematic Review. Womens Health Issues. 2022 Jul-Aug;32(4):369-375. doi: 10.1016/j.whi.2022.02.002. Epub 2022 Mar 15.

    PMID: 35304034BACKGROUND
  • Galmarini E, Marciano L, Schulz PJ. The effectiveness of visual-based interventions on health literacy in health care: a systematic review and meta-analysis. BMC Health Serv Res. 2024 Jun 11;24(1):718. doi: 10.1186/s12913-024-11138-1.

    PMID: 38862966BACKGROUND
  • Bengtson AM, Ramos SZ, Savitz DA, Werner EF. Risk Factors for Progression From Gestational Diabetes to Postpartum Type 2 Diabetes: A Review. Clin Obstet Gynecol. 2021 Mar 1;64(1):234-243. doi: 10.1097/GRF.0000000000000585.

    PMID: 33306495BACKGROUND
  • Olerich KLW, Souter VL, Fay EE, Katz R, Hwang JK. Cesarean delivery rates and indications in pregnancies complicated by diabetes. J Matern Fetal Neonatal Med. 2022 Dec;35(26):10375-10383. doi: 10.1080/14767058.2022.2128653. Epub 2022 Oct 6.

    PMID: 36202395BACKGROUND
  • Nour NM. An introduction to maternal mortality. Rev Obstet Gynecol. 2008 Spring;1(2):77-81.

    PMID: 18769668BACKGROUND
  • Baldwin MK, Hart KD, Rodriguez MI. Predictors for follow-up among postpartum patients enrolled in a clinical trial. Contraception. 2018 Sep;98(3):228-231. doi: 10.1016/j.contraception.2018.04.016. Epub 2018 May 8.

    PMID: 29750924BACKGROUND
  • DiBari JN, Yu SM, Chao SM, Lu MC. Use of postpartum care: predictors and barriers. J Pregnancy. 2014;2014:530769. doi: 10.1155/2014/530769. Epub 2014 Feb 20.

    PMID: 24693433BACKGROUND
  • Holmes VA, Young IS, Patterson CC, Pearson DW, Walker JD, Maresh MJ, McCance DR; Diabetes and Pre-eclampsia Intervention Trial Study Group. Optimal glycemic control, pre-eclampsia, and gestational hypertension in women with type 1 diabetes in the diabetes and pre-eclampsia intervention trial. Diabetes Care. 2011 Aug;34(8):1683-8. doi: 10.2337/dc11-0244. Epub 2011 Jun 2.

    PMID: 21636798BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

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

May 29, 2025

First Posted

June 6, 2025

Study Start

August 1, 2023

Primary Completion

June 1, 2024

Study Completion

July 1, 2024

Last Updated

June 6, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations