The TANGO-DM Randomized Controlled Trial Study Protocol
Overview of Gestational Diabetes Mellitus (GDM)
Gestational diabetes mellitus (GDM) is a condition that occurs in 7-10% of pregnancies worldwide. It is characterized by high blood sugar levels detected during pregnancy. The risk to the baby increases with higher blood sugar levels during tests.
New Diagnostic Criteria
The World Health Organization (WHO) updated its guidelines in 2013, recommending lower fasting blood sugar levels and higher thresholds after meals for diagnosing GDM compared to the 1999 guidelines. However, the effects of treating GDM under these new criteria are not well studied.
Study Hypothesis
We believe that treating GDM according to the new 2013 criteria will lead to fewer babies being born larger than normal (above the 90th percentile) compared to treatment based on the old criteria.
Study Design
The TANGO-DM trial is a multicenter study where pregnant women between 16 and 32 weeks of gestation are randomly assigned to one of two groups:
- Intensive GDM Treatment: This includes dietary guidance, blood sugar monitoring, and medication if needed.
- Normal Care: Women receive standard obstetric care without specific GDM treatment.
The main goal is to see how many babies are born larger than normal. Secondary goals include assessing maternal and newborn health, quality of life, and healthcare costs. We aim to include 1,032 participants to ensure accurate results.
Expected Outcomes
The TANGO-DM trial aims to provide strong evidence on whether the new WHO diagnostic criteria can effectively reduce the number of large babies and improve health outcomes for mothers and infants.
Trial Registration
This trial is registered with the Central Committee on Research Involving Human Subjects (CCMO) under the number NL63013.018.18 since September 22, 2018.
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