Multiple Micronutrients Supplementation on Angiogenesis and Vasculogenesis Factors, and Fetal Biometry
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- PlGF levels
研究概览
简要总结
Multiple micronutrients play an important role during pregnancy, since the decidualization and implantation phases. It has an impact on placentation and remodeling of blood vessels. The optimal early pregnancy conditions accompanied by great angiogenesis and vasculogenesis factors will influence fetal growth. This study aims to determine the effect of maternal multiple micronutrient supplementation on angiogenesis factors, vasculogenesis factors, and fetal biometry. It is a clustered randomized controlled trial that aims to determine the impact of maternal micronutrient supplementation on PlGF levels, sFlt-1/PlGF ratio, mean pulsatility index of uterine artery, and fetal biometry (head circumference, femur length, and estimated fetal weight percentile). The target population for the study was all pregnant women who underwent antenatal check-ups at community health centers in DKI Jakarta.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women with gestation age 8 - 14 weeks.
- •Singleton pregnancy.
- •Living in DKI Jakarta.
- •Can consume tablets or caplets.
- •Willing to only consume the vitamins used in the research
- •Willing to undergo antenatal examination at community health centers in DKI Jakarta.
- •Willing to be a research subject by signing the research consent form.
排除标准
- •Multiple pregnancies.
- •Pregnancy with assisted reproduction.
- •History of polycystic ovary syndrome.
- •History of chronic hypertension.
- •History of gestational diabetes mellitus.
- •Diagnosed with type 2 diabetes mellitus.
- •History of preeclampsia.
- •Recurrent miscarriage (Recurrent Pregnancy Loss).
- •Maternal medical conditions (Autoimmune; Heart Disease; Malignancy).
- •History of chronic infection.
- •Cannot consume tablets or caplets
- •Planning to move out of DKI Jakarta before and/or not giving birth in DKI Jakarta.
研究组 & 干预措施
Intervention
- Multiple micronutrient
- Calcium Carbonat 766 mg
- Vitamin D3 5000 IU
- DHA 300 mg
干预措施: Multiple Micronutrients (Dietary Supplement)
Control
Standard antenatal vitamins
干预措施: Standard Antenatal Vitamin (Drug)
结局指标
主要结局
PlGF levels
时间窗: It was carried out at gestational age: 1. Trimester 1: 8-14 weeks. 2. Trimester 2: 20-26 weeks.
Examination of angiogenesis factors in both research groups, using venous blood to measure Placental Growth Factor (PlGF) levels
mean pulsatility index of uterine artery
时间窗: 1. Trimester 1 : 8-14 weeks. 2. Trimester 2 : 20-26 weeks.
Examination of vasculogenesis factors by measuring the mean Pulsatility Index of bilateral uterine arteries
sFlt-1/PlGF ratio
时间窗: 20-26 weeks of gestation
Examination of the balance of angiogenesis factors in both groups, using venous blood to measure the ratio of soluble fms-Like Tyrosine Kinase-1 to Placental Growth Factor (s-Flt-1/PlGF),
Head circumference
时间窗: 20-26 weeks of gestation
Head circumference based on ultrasonography
Femur length
时间窗: 20-26 weeks of gestation
Femur length based on ultrasonography
Estimated fetal weight
时间窗: 20-26 weeks of gestation
Estimated fetal weight based on ultrasonography
次要结局
未报告次要终点
研究者
Amanda Rumondang
MD
Dr Cipto Mangunkusumo General Hospital