A Randomized Controlled Trial of Early Screening and Treatment of Women With Prediabetes in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 4
- 主要终点
- Number of Patients With a Diagnosis of Gestational Diabetes at 26 Weeks Gestation.
研究概览
简要总结
The investigators hope to learn whether treatment with medical nutrition therapy (MNT) for pregnant women with prediabetes decreases the rate and severity of impaired glucose tolerance later in pregnancy and improves perinatal outcomes. Given the rising rates of obesity and diabetes in this country even among young women and the adverse affects of diabetes of pregnant women and their infants, the investigators feel that it is important to not only identify women at high risk for diabetes early in pregnancy but determine the appropriate management strategy
详细描述
INTAKE VISIT: A health professional performs this visit soon after the diagnosis of pregnancy. Standardized glycosylated hemoglobin (A1C)is drawn as part of the routine prenatal panel at the above institutions. Women with an A1C of >6.5% are categorized as having type 2 diabetes, excluded from randomization, and referred for medical nutrition therapy, blood glucose monitoring, and insulin as needed. Women with an initial A1C <5.7% will receive routine prenatal care by their usual providers and will be screened for gestational diabetes Mellitus (GDM) in the second trimester per routine. Standard treatment for both these diabetic groups will be provided independently of this study, but anonymous outcome data will be available via hospital perinatal databases. Women with an A1c of 5.7-6.4% are eligible for the study.
EARLY PRENATAL VISIT: women with an A1C of 5.7-6.4% will be informed by their providers that they fall into a group labeled "prediabetes" outside of pregnancy and will be invited to learn about the study. All prediabetic women (agreeing to enroll or not) will be informed about general health risks and appropriate weight gain during pregnancy. Women who enroll will be queried regarding basic demographic information, pre-pregnancy weight, height, and obstetric and family history. Standardized weight, blood pressure (BP), and body mass index (BMI) will be recorded. Participants will be given a 1-page survey regarding their knowledge of risk factors for diabetes, appropriate weight gain in pregnancy, and the benefits of breastfeeding.
RANDOMIZATION AND MANAGEMENT: Women who enroll by 13 weeks gestation will be stratified by BMI < 30 or > 30 and randomized to either:
- Minimal Intervention (Control) Group: A single visit with a randomized control trial (RCT)-associated dietitian or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care as determined by provider.
- Treatment Group: Treatment for glucose intolerance including:
Diet: Regular visits with a dietitian every 2 weeks emphasizing a food and beverage plan (Institute of Medicine standards) of appropriate energy and no more than 45% carbohydrate; limited saturated fat; adequate protein, mineral and vitamin intake; and portion control by 'carbohydrate counting'. Food and beverage intake will be divided into 3 meals and 3 snacks and self-recorded on daily food records. Recommended choices of foods and carbohydrate type will take into account personal and cultural preferences. Standardized weight will be measured and charted at each visit. The MNT plan will be adjusted according to maternal weight gain and ongoing glycemic levels. Participants will continue the MNT plan until delivery, and it will be adjusted postpartum for the needs of breastfeeding. Furthermore this group will be treated with:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Singleton pregnancy
- •Prenatal care established at less than 14 weeks
- •A1C 5.7-6.4%
- •Delivery planned at Lucille Packard Children's Hospital at Stanford University (LPCH) or Santa Clara Valley Medical Center (SVMC)
排除标准
- •preexisting diabetes or chronic steroid use
- •known major fetal anomalies
研究组 & 干预措施
Treatment for glucose intolerance
Regular visit with dietician, exercise, self blood glucose monitoring, Insulin therapy if determined necessary.
干预措施: Treatment for glucose intolerance (Other)
Minimum intervention control group
Single visit with dietician or health educator followed by routine care per provider.
干预措施: Minimum intervention control group (Other)
结局指标
主要结局
Number of Patients With a Diagnosis of Gestational Diabetes at 26 Weeks Gestation.
时间窗: 26 weeks of gestation
Diagnosis based on criteria recommended by the ADA (Oral GTT with one abnormal value, fasting greater than or equal to 92, on hour greater than or equal to 180, two hour greater than or equal to 153)
次要结局
- Number of Participants With Need for Insulin Therapy(Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation)
- Number of Participants With Neonatal Hyperbilirubinemia(1 week after delivery)
- Mean Level of Postpartum Oral Glucose-tolerance-test at 6 Weeks Postpartum(6 weeks after delivery)
- Mean Hemoglobin A1C Value at Delivery(Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation)
- Mean Ponderal Index(Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation)
- Mean Level of Umbilical Cord C-peptide >=90th Percentile in the Whole Cohort(Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation)
- Mean Fasting Triglyceride Level(Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation)
- Number of Patients With Gestational Hypertension(Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation)
- Number of Patients With Pre-eclampsia(Up to 6 weeks after delivery)
- Mean Neonatal Birth Weight(Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation)
- Number of Participants With Intrauterine Fetal Demise(Duration of pregnancy and up to 28 days after delivery)
- Number of Participants With Different Modes of Delivery(Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation)
- Number of Participants With Neonatal Hypoglycemia(1 week after delivery)
- Number of Participants With Excessive Gestational Weight Gain(Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation)
研究者
Yasser Yehia El-Sayed
Professor of Obstetrics & Gynecology
Stanford University