Early Detection of Gestational Diabetes Mellitus in Pregnancy: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Gestational Diabetes Mellitus
研究概览
简要总结
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).
详细描述
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.
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
- Single (Outcomes Assessor)
盲法说明
Those assessing the outcomes from the medical chart will be blinded to the randomization process and the assigned study arm. Patients, the primary investigator, and their care providers will be aware of their treatment status.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Enhanced First Trimester GDM Screening (Diagnostic Test)
Standard of Care GDM 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.
干预措施: Routine Gestational Diabetes Screening (Diagnostic Test)
结局指标
主要结局
Gestational Diabetes Mellitus
时间窗: In pregnancy (24-28 weeks gestation)
Confirmed diagnosis of GDM based on 3 hour 100 gram glucose tolerance test
次要结局
- Neonatal Birthweight(At Birth)
- Number of participants with brachial plexus injury(At Birth)
- APGAR Score(At Birth)
- Neonatal Intensive Care Unit Admission(At delivery and within first 2 days of life)
- Mode of Delivery(At Birth)
- Gestational Age at Delivery(At Birth)
- Number of Participants with Shoulder Dystocia(At Birth)
- Patient Satisfaction with Diabetes Screening Method(Postpartum day 1 after birth)
研究者
Gianna Wilkie
Principal Investigator
University of Massachusetts, Worcester