A RANDOMIZED CLINICAL TRIAL OF TREATMENT FOR MILD GESTATIONAL DIABETES

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 轻度妊娠期糖尿病的饮食治疗(和必要的胰岛素治疗)是否会降低与母亲碳水化合物不耐受相关的新生儿发病率？轻度妊娠期糖尿病被定义为空腹血糖水平正常，两个或两个以上3小时口服葡萄糖耐量试验值异常。复合终点已被选为主要结果。这包括围产期死亡率和已被证明与母亲碳水化合物不耐受有关的围产期发病率，特别是死产、新生儿低血糖、新生儿高胰岛素血症、新生儿高胆红素血症和分娩创伤。就个人而言，这一复合结果的组成部分很少见。以前的许多研究都将巨大儿或胎龄较大作为主要结果，部分原因是证明对分娩创伤的影响所需的样本量将是令人望而却步的。通过结合相关疾病，这个问题是可以克服的。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Will dietary treatment (and insulin therapy as required) for mild gestational diabetes reduce the frequency of neonatal morbidity associated with maternal carbohydrate intolerance? Mild gestational diabetes is defined as a normal fasting glucose level with two or more 3-hour oral glucose tolerance test values being abnormal. A composite endpoint has been chosen as the primary outcome. This consists of perinatal mortality and perinatal morbidities that have been shown to be associated with maternal carbohydrate intolerance, specifically stillbirth, neonatal hypoglycemia, neonatal hyperinsulinemia, neonatal hyperbilirubinemia and birth trauma. Individually the components of this composite outcome are rare. Many previous studies have focused on macrosomia or large for gestational age as the primary outcome, partly because the sample size required to demonstrate an effect on birth trauma, for example, would be prohibitive. By combining relevant morbidities, this problem can be overcome.