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临床试验/NCT04116268
NCT04116268已完成不适用

The Effect of Obesity on Pregnancy and Fetal Outcome in Glucose Tolerant Mothers

University Malaysia Sarawak1 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2017年10月1日最近更新:
适应症

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

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

发起方
University Malaysia Sarawak
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Huai Heng, Loh

Associate Professor Dr.

University Malaysia Sarawak

研究点 (1)

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