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临床试验/NCT07489456
NCT07489456招募中不适用

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

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2026年3月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
182
试验地点
1
主要终点
Number of patients that attend to the postpartum OGTT

研究概览

简要总结

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).

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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.

干预措施: Whatsapp message (Other)

Control

No Intervention

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

结局指标

主要结局

Number of patients that attend to the postpartum OGTT

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

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

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tatiana Assunção Zaccara

MD PhD

University of Sao Paulo General Hospital

研究点 (1)

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