A RANDOMIZED CLINICAL TRIAL OF TREATMENT FOR MILD GESTATIONAL DIABETES

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 中心，不一定是研究者的机构。 轻度妊娠糖尿病的饮食治疗（必要时胰岛素治疗）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？ 轻度妊娠糖尿病定义为空腹血糖水平正常，但两次或两次以上3小时口服葡萄糖耐量试验值异常。选择复合终点作为主要结局。 这包括围产期死亡率和围产期发病率，已被证明与产妇碳水化合物不耐受有关，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产伤。 这种复合结果的各个组成部分是罕见的。 许多以前的研究都集中在巨大儿或大于胎龄儿作为主要结局，部分原因是证明对产伤的影响所需的样本量太大。 通过结合相关的发病率，这个问题可以克服。

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.