Screening for Dysglycemia During Postpartum Period in Women With GDM

Official title

Strategies for Improving the Detection of Dysglycemia in the Postpartum Period in Women With Gestational Diabetes: Electronic Reminders and New Diagnostic Criteria

Overview

Gestational diabetes mellitus (GDM) is one of the most common clinical conditions in pregnancy, with an increasing incidence due to the rise in overweight women and the postponement of motherhood. It is associated with perinatal complications and an increased risk of developing prediabetes and type 2 diabetes after delivery. Therefore, it is recommended that a 75g oral glucose tolerance test (OGTT-75g) be performed between 6 and 12 weeks postpartum. Despite its relevance, the rate of adherence to the test is low. Recent studies also indicate that measuring blood glucose one hour after the overload may be more sensitive than the traditional two-hour measurement in the early detection of dysglycemia. This study aims to evaluate strategies for qualifying the screening of metabolic changes in the postpartum period among women with GDM. The objectives are: (1) to analyze the impact of sending reminders via WhatsApp on the attendance rate for the 75g OGTT; and (2) to compare the frequency of prediabetes and diabetes diagnoses using two different diagnostic strategies applied to the same test-the traditional (fasting and 2-hour blood glucose) and the alternative (fasting and 1-hour blood glucose).

Detailed description

Gestational diabetes is one of the most common complications during pregnancy. With the increase in obesity and overweight in the population, as well as the postponement of motherhood, its incidence has been steadily increasing.

It is associated with complications such as polyhydramnios, macrosomia, premature labor, fetal death, hypoglycemia, and neonatal respiratory distress. Given the increase in the incidence of gestational diabetes and its clinical and epidemiological importance, a better understanding of the disease can promote improved care and prevention of its complications.

Women diagnosed with gestational diabetes mellitus (GDM) are at increased risk of developing prediabetes and type 2 diabetes in the years following childbirth. For this reason, national and international guidelines recommend performing a 75g oral glucose tolerance test (OGTT-75g) in the postpartum period, usually between six and 12 weeks after delivery, as a strategy for reclassifying glycemic status and early identification of persistent metabolic changes.

Despite the clinical relevance of the OGTT-75g in the follow-up of women with GDM, the rate of attendance for the test is notoriously low, especially in public health services. The reasons are multifactorial and include task overload in the postpartum period, logistical barriers, low risk perception, and the absence of systematic strategies to reinforce attendance. Simple interventions, such as sending reminders via electronic messages, have shown promise.

Considering the clinical and epidemiological relevance of GDM and these two complementary challenges-low attendance rates for screening and the diagnostic limitations of the current protocol-we propose two lines of investigation in this study:

1. to evaluate the impact of sending reminders via WhatsApp on the return rate for performing the 75g OGTT in the postpartum period; and 2. to compare the prevalence of glycemic changes identified by two different diagnostic strategies: the traditional one (fasting and two-hour blood glucose) and the new one (fasting and one-hour blood glucose). The results obtained may contribute to the qualification of care protocols and the prevention of adverse metabolic outcomes in women with a history of GDM.

Interventions

• Other Whatsapp message
  Automatic reminder messages via WhatsApp on days D-7 and D-3 in relation to the scheduled date for the exam.

Primary outcome measures

• Number of patients that attend to the postpartum OGTT [Time frame: From enrollment to the end of the recommended timeframe for postpartum OGTT (6 to 12 weeks after delivery)]

Secondary outcome measures (1)

• Dysglycemia rate according to diagnostic set of criteria [Time frame: From enrollment to OGTT test (6 to 12 weeks after delivery)]

Eligibility criteria

Inclusion criteria

• Diagnosis of gestational diabetes mellitus, according to diagnostic criteria proposed by the IADPSG, namely:
• initial fasting blood glucose ≥ 92mg/dL OR
• 75g oral glucose tolerance test with fasting ≥ 92mg/dL or after 1h ≥ 180mg/dL or after 2h ≥ 153mg/dL Delivery performed at HC-FMUSP Scheduling of the 75g oral glucose tolerance test between 6 and 12 weeks after delivery Agreement with the informed consent form

Exclusion criteria

Withdrawal of consent Failure to complete the TOTG exam due to vomiting (exclusion from analysis 2 only)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Screening

Study locations

Brazil · 1 center

• University of Sao Paulo General Hospital — São Paulo

Publications

• Milluzzo A, Manuella L, Frittitta L, Sciacca L. Efficacy of a phone reminder to improve adherence to post-partum glucose tolerance testing after gestational diabetes and clinical predictors of post-partum follow-up compliance. Diabetes Res Clin Pract. 2024 Apr;210:111653. doi: 10.1016/j.diabres.2024.111653. Epub 2024 Apr 2. PMID 38574892
• Egan AM, Dunne FP. Rethinking Postpartum Glucose Assessment: Is One-Hour Testing the Key to Success? Diabetes Care. 2025 Jun 1;48(6):874-876. doi: 10.2337/dci25-0021. No abstract available. PMID 40392998
• Buysschaert M, Bergman M, Valensi P. 1-h post-load plasma glucose for detecting early stages of prediabetes. Diabetes Metab. 2022 Nov;48(6):101395. doi: 10.1016/j.diabet.2022.101395. Epub 2022 Sep 29. PMID 36184047
• Retnakaran R, Ye C, Kramer CK, Hanley AJ, Connelly PW, Sermer M, Zinman B. One-Hour Oral Glucose Tolerance Test for the Postpartum Reclassification of Women With Hyperglycemia in Pregnancy. Diabetes Care. 2025 Jun 1;48(6):887-895. doi: 10.2337/dc24-1848. PMID 40029070
• McIntyre HD, Fuglsang J, Kampmann U, Knorr S, Ovesen P. Hyperglycemia in Pregnancy and Women's Health in the 21st Century. Int J Environ Res Public Health. 2022 Dec 15;19(24):16827. doi: 10.3390/ijerph192416827. PMID 36554709
• Bozkurt L, Gobl CS, Pfligl L, Leitner K, Bancher-Todesca D, Luger A, Baumgartner-Parzer S, Pacini G, Kautzky-Willer A. Pathophysiological characteristics and effects of obesity in women with early and late manifestation of gestational diabetes diagnosed by the International Association of Diabetes and Pregnancy Study Groups criteria. J Clin Endocrinol Metab. 2015 Mar;100(3):1113-20. doi: 10.1210/j PMID 25574889
• Hod M, Kapur A, Sacks DA, Hadar E, Agarwal M, Di Renzo GC, Cabero Roura L, McIntyre HD, Morris JL, Divakar H. The International Federation of Gynecology and Obstetrics (FIGO) Initiative on gestational diabetes mellitus: A pragmatic guide for diagnosis, management, and care. Int J Gynaecol Obstet. 2015 Oct;131 Suppl 3:S173-211. doi: 10.1016/S0020-7292(15)30033-3. No abstract available. PMID 26433807

Identifiers

NCT: NCT07489456 · 95734326.5.0000.0068

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗