4 Versus 7 Points Self-monitoring Blood Glucose in Gestational Diabetes on Diet Modification-A Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Demographic data of participants
研究概览
简要总结
This study aims to compare between 4 and 7 points blood glucose monitoring in women with gestational diabetes on diet modification.
详细描述
All women with gestational diabetes on diet modification will be recruited and randomised to 4 versus 7 points self monitoring blood glucose. They will be followed up 4 weekly and the pregnancy outcomes will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18-45 years old
- •Pregnant women with gestational diabetes mellitus on diet modification
- •Confirmed gestational diabetes mellitus using National Institute for Health and Care Excellence guideline by 75g oral glucose tolerance test after 14 weeks
- •Gestational age at recruitment 20-34 week
排除标准
- •bad obstetrics history.
- •Women with underlying medical disorders such as hypertension, autoimmune diseases on steroids
- •fetal anomaly.
- •Women planning to deliver in other centres
- •Women who refuse to participate
研究组 & 干预措施
4 points blood glucose monitoring
4 points of self monitoring blood glucose which comprises of fasting, 1 hour post breakfast, 1 hour post lunch and 1 hour post dinner
干预措施: diabetic diet (Dietary Supplement)
7 points blood glucose monitoring
7 points of self monitoring blood glucose which comprises of fasting,1 hour post breakfast, 1 hour pre and post lunch, 1 hour pre and post dinner, pre bed at 10 pm
干预措施: diabetic diet (Dietary Supplement)
结局指标
主要结局
Demographic data of participants
时间窗: On the date of randomisation up to 40 weeks gestation
Rate of positive family history of diabetes mellitus in percentage
Clinical characteristics of participants
时间窗: At the point of randomisation till 40 weeks gestation
Rate of antenatal complications such as preeclampsia, threatened preterm labour, preterm prelabour rupture of membranes, anaemia,
Pregnancy outcome of participants
时间窗: From date of randomisation up to 7 days after birth of the neonate
Rate of neonatal complications such as intrauterine fetal demise, neonatal death, neonatal hypoglycaemia, neonatal jaundice, neonatal respiratory distress syndrome and neonatal sepsis in percentage
Pregnancy outcome of participants
时间窗: From date of randomisation up to 40 weeks gestation
Mean gestational age at delivery in weeks
Pregnancy outcome of participants
时间窗: From date of randomisation up to 40 weeks gestation and participants are diagnosed in established labour
Rate of spontaneous or induced labour in percentage
Pregnancy outcome of participants
时间窗: From date of randomisation up to 40 weeks gestation when the participants had given birth to the newborn
Rate of vaginal, instrumental or caesarean delivery in percentage
Pregnancy outcome of participants
时间窗: From date of randomisation up to 40 weeks gestation during progress of labour up to 24 hours post delivery
Rate of intrapartum complications such as postpartum haemorrhage, shoulder dystocia and third or fourth degree tear in percentage
Pregnancy outcome of participants
时间窗: At the point of birth of the neonate
Mean neonatal birth weight in kilogram
Demographic data of participants
时间窗: On the date of randomisation
Mean age of participants in years
Demographic data of participants
时间窗: On the date of randomisation up to 40 weeks gestation based on the first trimester weight documented in the antenatal record
Mean prepregnancy body mass index in kg/m\^2
Demographic data of participants
时间窗: On the date of randomisation till 40 weeks gestation
Mean total weight gain in kilogram
Clinical characteristics of participants
时间窗: On the date of randomisation up to 40 weeks gestation
Mean gestational age gestational diabetes mellitus is diagnosed in weeks
次要结局
- Requirement of treatment in participants(From point of randomisation till 40 weeks gestation)
- Participants' satisfaction(From point of randomisation till 40 weeks gestation)
- Participants' compliance(From point of randomisation till 40 weeks gestation)
- Requirement of treatment in participants(From the date of randomisation up to 40 weeks gestation)
研究者
Rahana Abd Rahman
Principal Investigator
National University of Malaysia