Fetal Interventricular Septum Thickness and Maternal Gestational Diabetes Control
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Fetal interventricular septum thickness
研究概览
简要总结
Glucose intolerance and gestational diabetes are common complications of pregnancy. Their prevalence varies worldwide secondary to differences in screening practices (one-step versus two-step approach) and population characteristics (increased maternal age, body mass index, ethnicity). Gestational diabetes mellitus is associated with increased incidence of macrosomia, operative vaginal delivery, shoulder dystocia, cesarean delivery, metabolic complications in the newborn and long-term risk of developing type II diabetes mellitus (HAPO 2008).
Early diagnosis and management of gestational diabetes mellitus, including dietary advice and insulin, improves maternal and fetal outcomes (Crowther 2005, Hartling 2013). Various strategies have been tested prenatally to detect those fetuses that might be adversely affected by gestational diabetes mellitus. For instance, the abdominal circumference measurement during routine fetal biometry was used successfully to identify pregnancies with a higher risk of fetal macrosomia (Schaefer-Graf 2003, De Reu 2008, Rosati 2010). In recent years, the fetal interventricular septum thickness, as detected by two-dimensional ultrasound, was shown to be significantly thicker in the presence of gestational diabetes mellitus, independently of maternal glycemic control, when compared to pregnancies with no gestational diabetes mellitus (Ren 2011, Garg 2014).
Current guidelines focus on normalisation of maternal blood glucose concentration. Thus far no study has addressed whether measurement of the fetal interventricular septum thickness can predict adverse pregnancy outcome in euglycemic women with gestational diabetes mellitus.
详细描述
Rational for the study If fetal interventricular septum hypertrophy in pregnancies with gestational diabetes mellitus appears prior to either fetal abdominal circumference measurement > 90th percentile or the abnormal maternal glucose levels, then future management of women with gestational diabetes mellitus might be targeted earlier at these pregnancies to ensure a more favorable outcome.
Objective To determine the thickness of fetal interventricular septum in women with and without gestational diabetes mellitus and correlates it with perinatal outcome.
Methods Study design This is a prospective study at Rambam Health Care Campus. Inclusion / Exclusion criteria
- Inclusion Study group - women between 24 - 34 weeks' gestation who were diagnosed with gestational diabetes mellitus or known with type I or type II diabetes mellitus.
Control group - women between 24 - 34 weeks' gestation who do not have diabetes. 2. Exclusion (that might affect directly or indirectly the fetal cardiac function) - women who did not complete a glucose challenge test, smoking, underlying cardiac or respiratory illness, fetal growth restriction, medicated hypertension disorder of pregnancy, multiple pregnancy, use of steroids for lung maturation in the current pregnancy and known major congenital anomalies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Study group - women between 24 - 34 weeks' gestation who were diagnosed with gestational diabetes mellitus or known with type I or type II diabetes mellitus.
- •Control group - women between 24 - 34 weeks' gestation who do not have diabetes.
排除标准
- •women who did not complete a glucose challenge test, smoking, underlying cardiac or respiratory illness, fetal growth restriction, medicated hypertension disorder of pregnancy, multiple pregnancy, use of steroids for lung maturation in the current pregnancy and known major congenital anomalies.
研究组 & 干预措施
Diabetes group
Women with gestational or pre-gestational diabetes mellitus.
干预措施: Fetal interventricular septum thickness (Diagnostic Test)
Control group
Women without gestational or pre-gestational diabetes mellitus.
干预措施: Fetal interventricular septum thickness (Diagnostic Test)
结局指标
主要结局
Fetal interventricular septum thickness
时间窗: Between 24-34 weeks of gestation.
Differences in fetal interventricular septum thickness in both women with gestational or pre-gestational diabetes mellitus and women without gestational or pre-gestational diabetes mellitus.
次要结局
未报告次要终点
研究者
Yaniv Zipori MD
Principal Investigator
Rambam Health Care Campus