Screening for Dysglycemia During Postpartum Period in Women With GDM

NCT07489456 | Recruiting

• 1 other identifier: 95734326.5.0000.0068
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Gestational Diabetes Mellitus (GDM)

Keywords

dysglycemia; gestational diabetes; prediabetes; diabetes; postpartum OGTT

Outcome Measures

Primary Outcomes (1)

• Number of patients that attend to the postpartum OGTT

  Impact of electronic messages in the attendance rate of postpartum women with GDM at the TOTG-75g exam between 6 and 12 weeks after delivery

  From enrollment to the end of the recommended timeframe for postpartum OGTT (6 to 12 weeks after delivery)

Secondary Outcomes (1)

• Dysglycemia rate according to diagnostic set of criteria

  From enrollment to OGTT test (6 to 12 weeks after delivery)

Study Arms (2)

Control

NO INTERVENTION

Control Group (current practice): will not receive reminder messages for the exam.

Intervention group

EXPERIMENTAL

Intervention Group: will receive automatic reminder messages via WhatsApp on days D-7 and D-3 in relation to the scheduled date for the exam. If the patient does not attend, she will receive a single additional message on the following business day, offering the possibility of rescheduling. Rescheduled exams will not receive new reminders. The message sent will contain a read receipt request to ensure that the patient has received the text. If the patient requests to reschedule the exam before the originally scheduled date, we will consider the new date as D for sending reminder messages.

Other: Whatsapp message

Interventions

Whatsapp message OTHER

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

Intervention group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of gestational diabetes mellitus, according to diagnostic criteria proposed by the IADPSG, namely:
• initial fasting blood glucose ≥ 92mg/dL OR
• g 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of Sao Paulo General Hospital

São Paulo, São Paulo, 05.403-905, Brazil

RECRUITING

Related Publications (7)

• 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 Research and Clinical Practice. 2024 Apr;210:111653. Available from: https://doi.org/10.1016/j.diabres.2024.111653

  BACKGROUND

• Egan AM, Dunne FP. Rethinking Postpartum Glucose Assessment: Is One-Hour Testing the Key to Success? Vol. 48, Diabetes Care. American Diabetes Association Inc.; 2025. p. 874-6.

  BACKGROUND

• Buysschaert M, Bergman M, Valensi P. 1-h post-load plasma glucose for detecting early stages of prediabetes. Vol. 48, Diabetes and Metabolism. Elsevier Masson s.r.l.; 2022.

  BACKGROUND

• Retnakaran R, Ye C, Kramer CK, Hanley AJ, Connelly PW, Sermer M, et al. One-Hour Oral Glucose Tolerance Test for the Postpartum Reclassification of Women With Hyperglycemia in Pregnancy. Diabetes Care. 2025 Jun 1;48(6):887-95.

  BACKGROUND

• McIntyre HD, Fuglsang J, Kampmann U, Knorr S, Ovesen P. Hyperglycemia in Pregnancy and Women's Health in the 21st Century. Vol. 19, International journal of environmental research and public health. NLM (Medline); 2022.

  BACKGROUND

• Bozkurt L, Göbl CS, Pfligl L, Leitner K, Bancher-Todesca D, Luger A, et al. 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. Journal of Clinical Endocrinology and Metabolism. 2015 Mar 1;100(3):1113-20.

  BACKGROUND

• Hod M, Kapur A, Sacks DA, Hadar E, Agarwal M, Di Renzo GC, et al. The International Federation of Gynecology and Obstetrics (FIGO) Initiative on gestational diabetes mellitus: A pragmatic guide for diagnosis, management, and care#. International Journal of Gynecology & Obstetrics [Internet]. 2015 Oct 1;131(S3):S173-211. Available from: https://doi.org/10.1016/S0020-7292(15)30033-3

  BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes, Gestational; Prediabetic State; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Tatiana A Zaccara, MD PhD

CONTACT

+551126616209; tatiana.assuncao@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Model Details: This is a randomized, open-label clinical trial with two parallel groups, aiming to evaluate the effect of sending reminder messages via institutional WhatsApp on the attendance rate at TOTG-75g in the postpartum period. Eligible participants will be randomly allocated, using a computer-generated sequence, into two groups: Control Group (current practice): will not receive reminder messages for the exam. Intervention Group: will receive automatic reminder messages via WhatsApp on days D-7 and D-3 in relation to the scheduled date for the exam. If the patient does not attend, she will receive a single additional message on the following business day, offering the possibility of rescheduling. Rescheduled exams will not receive new reminders. The message sent will contain a read receipt request to ensure that the patient has received the text. If the patient requests to reschedule the exam before the originally scheduled date, we will consider the new date as D

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 24, 2026
• Study Start: March 24, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

BR (1)