Glycemic Variability on Continuous Glucose Monitoring Predicts Small-for-Gestational-Age Neonates in Pregnancies After Metabolic and Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Birth weight
研究概览
简要总结
Pregnancies after Metabolic and Bariatric Surgery (MBS) are linked to increased incidence of small-for-gestational-age (SGA) neonates. Hypoglycemia and glucose variability (GV) are known determinants of fetal growth; however, their impact on neonatal birth weight in pregnancies after MBS remains unclear.
This study aims to assess whether glycemic profiles in these pregnancies are associated with fetal growth and to determine if specific GV parameters can predict growth restriction and SGA neonates.
This is a single-center prospective cohort study of pregnant women previously post-MBS who underwent intermittently scanned continuous glucose monitoring (isCGM) once for trimester of pregnancy, allowing their glycemic profile to be analyzed.
The primary aims of this study were to evaluate the extent to which the glycemic profile of pregnant women after MBS impacts fetal growth, and to identify which specific GV parameters may be used to predict fetal growth restriction and SGA neonates.
详细描述
Prespecified clinical data for both participants and their newborns were collected from electronic medical records - neonates were then classified as appropriate-for-gestational-age (AGA) or small-for-gestational- age (SGA).
The glucose sensors were placed by the clinical team during the appointments in the back of the arm, and participants were trained on the appropriate use of the devices.
All women were followed up by a multidisciplinary antenatal care team comprising obstetricians, endocrinologists, and dietitians. Standard pregnancy management included regular outpatient appointments for clinical follow-up and laboratory assessments of nutritional status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Pregnant women who underwent metabolic bariatric surgery
- •Enrollement at first or second trimesters of pregnancy
排除标准
- •Twin pregnancies
- •Pregnancies ending in miscarriage
- •Pregnancies with planned delivery at other institution
结局指标
主要结局
Birth weight
时间窗: At delivery (up to 41 gestational weeks)
Birth weight measured in grams
Mean absolute glucose change [MAG change]
时间窗: During two weeks - once per trimester of pregnancy
MAG change measures the average rate of glucose change over time, capturing both magnitude and speed. Unit: mg/dLxh-1
次要结局
未报告次要终点
研究者
Diana Rodrigues dos Santos Martins
Principal Investigator
Centro Hospitalar Universitário de Santo António