- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07009106
- Original Trial
Pilot Randomized Control Trial to Assess the Impact of Video Education on Postpartum Care Knowledge and Attendance Among Pregnant Individuals With Diabetes
Improving Postpartum Care Knowledge and Visit Attendance in Expecting Persons With Diabetes Through an Educational Video Pilot Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Rhode Island
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Providence, Rhode Island, United States, 02905
- Obstetrics & Gynecology Center (OGCC)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of Type 1 Diabetes, Type 2 Diabetes, or gestational diabetes
- 28 weeks gestational age or later
- 18-50 years of age
- English or Spanish speaking
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control Group
Participants received standard prenatal care
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Experimental: Video Intervention
Participants watched a short educational video on postpartum care during a regularly scheduled prenatal visit
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Participants watched a short educational video on postpartum care during a regularly scheduled prenatal visit.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in baseline postpartum care knowledge after video education intervention
Time Frame: From pre-video survey during enrollment to immediately after video intervention (1-2 weeks later)
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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.
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From pre-video survey during enrollment to immediately after video intervention (1-2 weeks later)
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Rate of attendance to the postpartum visit
Time Frame: 12 weeks after delivery
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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.
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12 weeks after delivery
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Nour NM. An introduction to maternal mortality. Rev Obstet Gynecol. 2008 Spring;1(2):77-81.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1931623
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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