Pilot Randomized Control Trial to Assess the Impact of Video Education on Postpartum Care Knowledge and Attendance Among Pregnant Individuals With Diabetes

NCT ID: NCT07009106

Last Updated: 2025-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Postpartum Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control Group

Participants received standard prenatal care

Group Type NO_INTERVENTION

No interventions assigned to this group

Video Intervention

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

Group Type EXPERIMENTAL

Educational video on postpartum care

Intervention Type OTHER

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

Interventions

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Educational video on postpartum care

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Women and Infants Hospital of Rhode Island

OTHER

Sponsor Role lead

Responsible Party

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Laurie Griffin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Obstetrics & Gynecology Center (OGCC)

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 28207685 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12351492 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28263752 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35304034 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38862966 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33306495 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36202395 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 18769668 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29750924 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24693433 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21636798 (View on PubMed)

Other Identifiers

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1931623

Identifier Type: -

Identifier Source: org_study_id

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