Screening for Dysglycemia During Postpartum Period in Women With GDM

University of Sao Paulo General Hospital

Status: Not yet enrolling

Conditions: Gestational Diabetes Mellitus (GDM)

Treatments: Other: Whatsapp message

Study type: Interventional

Funder types: Other

Identifiers

NCT07489456

95734326.5.0000.0068

Details and patient eligibility

About

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).

Full 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.

Enrollment: 182 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

182 participants in 2 patient groups

Control

No Intervention group

Description:

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

Intervention group

Experimental group

Description:

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.

Treatment:

Other: Whatsapp message