Early Detection of Gestational Diabetes Mellitus in Pregnancy

Официальное название

Early Detection of Gestational Diabetes Mellitus in Pregnancy: A Randomized Trial

Обзор

The purpose of this study is to develop an implementation protocol and test the feasibility and acceptability of a first trimester screening protocol for the early detection of gestational diabetes mellitus (GDM).

Подробное описание

Gestational diabetes mellitus (GDM) is an important contributor to both maternal and neonatal morbidity and mortality in pregnancy. GDM has lifelong complications including an increased risk of developing type 2 diabetes mellitus and cardiovascular disease for women, and their offspring are at higher risk of being obese and also having diabetes in childhood and adolescence. Approximately 1 in 8 pregnancies is impacted by gestational diabetes mellitus worldwide. First trimester GDM screening is varied due to conflicting national guidelines, and the best strategy is unknown. The goal of the proposed research is to develop an implementation protocol and test the feasibility and acceptability of a first trimester screening protocol for the early detection of GDM. The investigators will utilize a pilot randomized controlled trial to recruit 80 high-risk pregnant women in the first trimester, of whom half will receive protocolized early GDM screening with serum biomarkers before 12 weeks and the remaining half will receive the current standard of care with screening between 24 and 28 weeks of gestation with possible early screening based on provider discretion.

Вмешательства

• Диагностический тест Enhanced First Trimester GDM Screening
  Women who are randomly assigned to this condition will be required to have early glucose screening with a prediction model composed of additional clinical risk factors and serum biomarkers (triglycerides, PAPP-A, and lipocalin-2) with their initial prenatal laboratory assessment.
• Диагностический тест Routine Gestational Diabetes Screening
  Women who will be randomized to the comparison condition of usual standard of care will undergo routine standard of care. The standard of care will consist of routine screening for diabetes in pregnancy between 24 to 28 weeks of gestation via the two-step screening method with possible early screening with either plasma fasting glucose, oral glucose tolerance test, or hemoglobin A1c at the providers discretion to represent true clinical practice.

Первичные конечные точки

• Gestational Diabetes Mellitus [Срок оценки: In pregnancy (24-28 weeks gestation)]

Вторичные конечные точки (8)

• Mode of Delivery [Срок оценки: At Birth]
• Neonatal Birthweight [Срок оценки: At Birth]
• Number of Participants with Shoulder Dystocia [Срок оценки: At Birth]
• Number of participants with brachial plexus injury [Срок оценки: At Birth]
• APGAR Score [Срок оценки: At Birth]
• Neonatal Intensive Care Unit Admission [Срок оценки: At delivery and within first 2 days of life]
• Gestational Age at Delivery [Срок оценки: At Birth]
• Patient Satisfaction with Diabetes Screening Method [Срок оценки: Postpartum day 1 after birth]

Критерии участия

Критерии включения

• 1\) age greater than or equal to 18 years old,
• 2\) singleton gestation less than or equal to 12 weeks at initial obstetric visit,
• 3\) receiving prenatal care at UMMHC and plans to deliver at UMMHC,
• 4\) able and willing to provide informed consent,
• 5\) English or Spanish speaking, and
• 6\) are at high risk for developing GDM by ACOG clinical risk factor guidelines.

Критерии исключения

• 1\) known diagnosis of pre-existing pregestational diabetes,
• 2\) plan to receive prenatal care or deliver outside of UMMHC,
• 3\) inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test), or
• 4\) systemic steroid use.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Скрининг

Центры проведения

США · 1 центр

• University of Massachusetts Memorial Medical Center — Worcester

Публикации

• Sweeting AN, Wong J, Appelblom H, Ross GP, Kouru H, Williams PF, Sairanen M, Hyett JA. A Novel Early Pregnancy Risk Prediction Model for Gestational Diabetes Mellitus. Fetal Diagn Ther. 2019;45(2):76-84. doi: 10.1159/000486853. Epub 2018 Jun 13. PMID 29898442
• Nanda S, Savvidou M, Syngelaki A, Akolekar R, Nicolaides KH. Prediction of gestational diabetes mellitus by maternal factors and biomarkers at 11 to 13 weeks. Prenat Diagn. 2011 Feb;31(2):135-41. doi: 10.1002/pd.2636. Epub 2010 Dec 28. PMID 21268030

Идентификаторы

NCT: NCT05388643 · STUDY00002047 · K23HD111526

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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