The Effect of Obesity on Pregnancy and Fetal Outcome in Glucose Tolerant Mothers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Number of participants who develop pregnancy-induced hypertension
研究概览
简要总结
The participants are divided into subjects or controls based on the BMI taken during the first trimester of pregnancy upon recruitment. Participants with a BMI of ≥23kg/m2 were recruited as subjects (labelled as obese group) and those with BMI of 18.5-23kg/m2 were recruited as controls. Total gestational weight gain was calculated based on the difference between third trimester weight and first trimester weight. All participants who fulfilled the inclusion and exclusion criteria were recruited after informed consent. Demographic data of all participants were recorded. At first trimester, the participants' weight and height were recorded for calculation of BMI. At every trimester visit, the following were recorded: i) blood pressure using sphygmomanometer after 15 minutes of rest ii) mid-stream urine for presence of proteinuria iii) weight. The participants were followed up until the point of delivery. Occurrence of adverse pregnancy outcome, fetal outcome, and birth weight were documented. The pregnancy outcomes measured in this study included the need of primary caesarian section, the occurrence of pregnancy-induced hypertension (PIH), pre-eclampsia, and gestational age at delivery. The neonatal outcomes measured in this study included neonatal intensive care unit (NICU) admission, stillbirth, preterm delivery, occurrence of macrosomia and low birth weight, and neonatal birth weight.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •First trimester of pregnancy
- •Aged 18 years or older
- •Able to come for follow up at least once per trimester
排除标准
- •Underlying diabetes mellitus
- •Gestational diabetes mellitus diagnosed via OGTT
- •Known genetic disorders affecting growth at time of recruitment
- •Known congenital anomalies at time of recruitment
- •Conceived via artificial insemination
- •Hepatitis B/C/HIV infection
结局指标
主要结局
Number of participants who develop pregnancy-induced hypertension
时间窗: 9 months
Number of participants who require primary caesarian section
时间窗: 9 months
Number of preterm delivery
时间窗: 9 months
Number of participants who develop pre-eclampsia
时间窗: 9 months
Number of low birth weight at delivery
时间窗: 9 months
Birth weight less than 2500g
Number of neonates who require neonatal intensive care unit admission
时间窗: 9 months
Gestational age at delivery
时间窗: 9 months
Number of macrosomia at delivery
时间窗: 9 months
Birth weight more than 4000g
Birth weight
时间窗: 9 months
Number of stillbirth
时间窗: 9 months
次要结局
未报告次要终点
研究者
Dr Huai Heng, Loh
Associate Professor Dr.
University Malaysia Sarawak
