Maternal Optimalization on Nutrition for Better Pregnancy Outcomes (MONAS Study)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 245
- 试验地点
- 1
- 主要终点
- Composite of poor maternal outcomes
研究概览
简要总结
The goal of this MONAS Study is to learn about comprehensive monitoring and nutritional intervention among pregnant women in order to improve maternal and neonatal outcomes. The main questions it aims to answer are:
- Are comprehensive monitoring and nutritional intervention among pregnant women can improve maternal outcomes (maternal death, preterm labour, preeclampsia, intrauterine infection, and bleeding during pregnancy and delivery) compared to standard maternal health services?
- Are comprehensive monitoring and nutritional intervention among pregnant women can improve neonatal outcomes (neonatal death, low birth weight, intrauterine growth restriction, and neonatal asphyxia) compared to standard maternal health services?
Participants in the intervention group will receive:
- Fetomaternal ultrasound examination each trimester
- Complete laboratory examination for nutritional panel (complete blood count with reticulocyte profile and iron profile, vitamin D level, zinc level, fatty acid profile, electrophoresis for Thalassemia) as an addition to standard maternal routine laboratory examination
- Supplements: multivitamin, minerals, vitamin D, fatty acid
- Intervention regarding any abnormal results of nutritional panel
- All standard maternal health services according to Indonesian Ministry of Health protocol
Participants in the control group will receive:
- All standard maternal health services according to Indonesian Ministry of Health protocol
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnancy in 1st trimester
- •Gestational age less than 10 weeks
- •Living in Jakarta greater area
- •Agree to participate
排除标准
- •Assisted reproductive technology (IVF)
- •History of polycystic ovary syndrome
- •History of chronic hypertension
- •History of diabetes mellitus
- •History of preeclampsia in the previous pregnancy
- •Had chronic disease: heart disease, autoimmune disease, malignancy, chronic lung disease
- •Planning to have delivery outside Jakarta greater area
- •Poor obstetric history (miscarriage/ abortion more than 3 times)
研究组 & 干预措施
Control group
Participants in the control group will receive:
- All standard maternal health services according to Indonesian Ministry of Health protocol
Intervention group
Participants in the intervention group will receive:
- Fetomaternal ultrasound examination each trimester by fetomaternal consultants
- Complete laboratory examination for nutritional panel (complete blood count with reticulocyte profile and iron profile, vitamin D level, zinc level, fatty acid profile, electrophoresis for Thalassemia) as an addition to standard maternal routine laboratory examination
- Supplements: multivitamin, minerals, vitamin D, fatty acid
- Intervention regarding any abnormal results of nutritional panel
- All standard maternal health services according to Indonesian Ministry of Health protocol
干预措施: Nutritional panel laboratory examination (Diagnostic Test)
Intervention group
Participants in the intervention group will receive:
- Fetomaternal ultrasound examination each trimester by fetomaternal consultants
- Complete laboratory examination for nutritional panel (complete blood count with reticulocyte profile and iron profile, vitamin D level, zinc level, fatty acid profile, electrophoresis for Thalassemia) as an addition to standard maternal routine laboratory examination
- Supplements: multivitamin, minerals, vitamin D, fatty acid
- Intervention regarding any abnormal results of nutritional panel
- All standard maternal health services according to Indonesian Ministry of Health protocol
干预措施: Pregnancy supplements (other than provided by Ministry of Health) (Dietary Supplement)
Intervention group
Participants in the intervention group will receive:
- Fetomaternal ultrasound examination each trimester by fetomaternal consultants
- Complete laboratory examination for nutritional panel (complete blood count with reticulocyte profile and iron profile, vitamin D level, zinc level, fatty acid profile, electrophoresis for Thalassemia) as an addition to standard maternal routine laboratory examination
- Supplements: multivitamin, minerals, vitamin D, fatty acid
- Intervention regarding any abnormal results of nutritional panel
- All standard maternal health services according to Indonesian Ministry of Health protocol
干预措施: Fetomaternal ultrasound (Diagnostic Test)
结局指标
主要结局
Composite of poor maternal outcomes
时间窗: At anytime between 20 weeks of gestational age until 28 days after delivery
Number of participants with a combination of maternal death, preterm labour, preeclampsia, intrauterine infection, and bleeding during pregnancy and or after delivery
Composite of poor neonatal outcomes
时间窗: After delivery of participants (any gestational age) until 28 days of chronological age
A number of baby born from participants with a combination of neonatal death, low birth weight, intrauterine growth restriction, neonatal asphyxia, and need of admission to intensive care untill 28 daya of age
次要结局
未报告次要终点
研究者
Hardya Gustada Hikmahrachim
Principal Investigator, Member of Department of Child Health
Dr Cipto Mangunkusumo General Hospital