Evaluating for Type-2 Diabetes in the Very Early Post-Partum Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Result of an early postpartum 75-gram oral glucose tolerance test (GTT) result
研究概览
简要总结
Pregnancy-associated diabetes, known as gestational diabetes mellitus (GDM), is associated with an increased lifetime risk of developing diabetes mellitus (DM) or pre-diabetes. Up to 30% of women with GDM will continue have abnormal blood glucose tests 6 or more weeks after delivery. Early diagnosis and treatment of continued impaired glucose metabolism or DM is essential because serious health problems can result.
Current guidelines recommend a 75-gram, 2-hour glucose tolerance test (GTT) 6 or more weeks after delivery for women diagnosed with GDM in order to identify those with continued DM or impaired glucose metabolism. However, approximately half of these women do not get glucose testing after delivery. The ability to test women while they are still hospitalized after having a baby could greatly increase diagnosis, care and treatment of women with abnormal glucose metabolism.
Our objective is to determine if a 75-gram, 2-hour GTT administered to women with GDM two to four days after delivery can identify those who will have an abnormal GTT at 6-12 weeks after delivery.
详细描述
This will be a prospective cohort study conducted at Winthrop-University Hospital. Women 18 years old or older who delivered a child or fetus within the previous 4 days at either hospital who also were diagnosed with GDM during the pregnancy will be eligible for participation. Women will be excluded if they have issues that would interfere with administration of a GTT, are unable /unwilling to provide informed consent, or cannot follow up. Anticipated enrollment will be 250 women at each study site.
While still hospitalized two to four days postpartum, subjects will undergo a 75-gram, 2-hour GTT and have blood tested for hemoglobin A1c and glucose levels. They will be reminded to do the recommended GTT 6-12 weeks after delivery. Maternal, neonatal, and obstetric characteristics will be collected, including the any GTT results. The results of the in-hospital GTT will be compared to the result of the GTT taken 6-12 weeks postpartum and tested for correlation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Women 18 years old or older
- •Delivered a child or fetus within the previous 4 days
- •Diagnosed with gestational diabetes during the pregnancy
排除标准
- •Unable or unwilling to provide informed consent for the study
- •Unable to undergo or complete a 2-hour oral glucose tolerance test 2-4 days postpartum
- •Unable or unwilling to have study follow up.
结局指标
主要结局
Result of an early postpartum 75-gram oral glucose tolerance test (GTT) result
时间窗: 2-4 days postpartum
The GTT result obtained 2-4 days postpartum will be compared to the GTT result obtained 6-12 weeks postpartum using the McNemar test for paired proportions.
次要结局
- Result of a postpartum 75-gram oral glucose tolerance test (GTT)(6 weeks-6 months postpartum)