A Novel Care Pathway in Women With "Low-risk" Gestational Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Feasibility of the novel risk stratification screening tool
研究概览
简要总结
This study is a randomized controlled trial to study the effect of the use of a risk stratification screening tool for high- and low-risk gestational diabetes mellitus (GDM), and the implementation of a new low-impact care pathway for women with low-risk GDM. The study will measure how well the screening tool and new care pathway are used, and the effect of the new low-impact care pathway on glycemic control, perinatal outcomes (large for gestational age, rate of labor induction, mode of delivery, obstetric anal sphincter injury, neonatal hypoglycemia, neonatal anthropometry) and health resource utilization in women with GDM that are at low-risk of dietary therapy failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women able to understand and sign the study consent form
- •singleton pregnancy
- •planning to give birth to at St. Michael's Hospital
- •diagnosed with GDM between 24-32 weeks' gestation based on a positive GCT or GTT result as defined by the Canadian Diabetes Association Clinical Practice Guidelines
排除标准
- •Women with preexisting diabetes (Type 1 or 2 diabetes)
- •multiple gestation, or a diagnosis of GDM before 24 weeks' or after 32 weeks' gestation
- •not continuing care at St. Michael's Hospital after the DIP clinic visit
结局指标
主要结局
Feasibility of the novel risk stratification screening tool
时间窗: 2 years
number of patients screened, recruited, consented and randomized as documented in the study recruitment log
次要结局
- Gestational weight gain(approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum))
- Development of hypertensive disorders of pregnancy(approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum))
- Delivery outcomes - mode of delivery(recorded at time of delivery)
- Neonatal outcomes - Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score(recorded at delivery (at 1 minute and 5 minutes of age))
- Performance of the GDM risk stratification tool(2 years)
- Glycemic control - blood glucose (units)(approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum))
- Glycemic control - blood glucose (percent above target)(approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum))
- Neonatal outcomes - size for gestational age(recorded at time of delivery)
- Health service outcomes - Short-form Patient Satisfaction Questionnaire (PSQ-18)(2 years; administered to each participant at 6-weeks postpartum)
- Delivery outcomes - gestational age at delivery(recorded at time of delivery)
- Health service outcomes - health resource utilization(2 years)