The Effect of Obesity on Pregnancy and Fetal Outcome in Glucose Tolerant Mothers
2019年10月8日 更新者:Dr Huai Heng, Loh、University Malaysia Sarawak
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.
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
225
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Sarawak
-
Kuching、Sarawak、马来西亚、94300
- Universiti Malaysia Sarawak
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
女性
取样方法
非概率样本
研究人群
Pregnant during first trimester
描述
Inclusion Criteria:
- First trimester of pregnancy
- Aged 18 years or older
- Able to come for follow up at least once per trimester
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
---|
Obesity
BMI >23kg/m2
|
Control
BMI 18-22.9kg/m2
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Number of participants who develop pregnancy-induced hypertension
大体时间:9 months
|
9 months
|
|
Number of neonates who require neonatal intensive care unit admission
大体时间:9 months
|
9 months
|
|
Number of participants who develop pre-eclampsia
大体时间:9 months
|
9 months
|
|
Number of participants who require primary caesarian section
大体时间:9 months
|
9 months
|
|
Gestational age at delivery
大体时间:9 months
|
9 months
|
|
Number of stillbirth
大体时间:9 months
|
9 months
|
|
Number of preterm delivery
大体时间:9 months
|
9 months
|
|
Number of macrosomia at delivery
大体时间:9 months
|
Birth weight more than 4000g
|
9 months
|
Number of low birth weight at delivery
大体时间:9 months
|
Birth weight less than 2500g
|
9 months
|
Birth weight
大体时间:9 months
|
9 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Huai Heng Loh、University Malaysia Sarawak
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年10月1日
初级完成 (实际的)
2019年3月31日
研究完成 (实际的)
2019年9月30日
研究注册日期
首次提交
2019年10月3日
首先提交符合 QC 标准的
2019年10月3日
首次发布 (实际的)
2019年10月4日
研究记录更新
最后更新发布 (实际的)
2019年10月10日
上次提交的符合 QC 标准的更新
2019年10月8日
最后验证
2019年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.