Angiogenesis, Fetal Weight, High Risk Pregnancy, Nutrient Element Deficiency, Pregnancy Related
Conditions
Keywords
micronutrients, angiogenesis, vasculogenesis, fetal biometry
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTMultiple Micronutrients
1. Multiple micronutrient 2. Calcium Carbonat 766 mg 3. Vitamin D3 5000 IU 4. DHA 300 mg
DRUGStandard Antenatal Vitamin
Standard Antenatal Vitamin given in Community Health Centers
Sponsors
Dr Cipto Mangunkusumo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
1. Pregnant women with gestation age 8 - 14 weeks. 2. Singleton pregnancy. 3. Living in DKI Jakarta. 4. Can consume tablets or caplets. 5. Willing to only consume the vitamins used in the research 6. Willing to undergo antenatal examination at community health centers in DKI Jakarta. 7. Willing to be a research subject by signing the research consent form.
Exclusion criteria
1. Multiple pregnancies. 2. Pregnancy with assisted reproduction. 3. History of polycystic ovary syndrome. 4. History of chronic hypertension. 5. History of gestational diabetes mellitus. 6. Diagnosed with type 2 diabetes mellitus. 7. History of preeclampsia. 8. Recurrent miscarriage (Recurrent Pregnancy Loss). 9. Maternal medical conditions (Autoimmune; Heart Disease; Malignancy). 10. History of chronic infection. 11. Cannot consume tablets or caplets 12. Planning to move out of DKI Jakarta before and/or not giving birth in DKI Jakarta.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sFlt-1/PlGF ratio | 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), |
| mean pulsatility index of uterine artery | 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 |
| Head circumference | 20-26 weeks of gestation | Head circumference based on ultrasonography |
| PlGF levels | 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 |
| Femur length | 20-26 weeks of gestation | Femur length based on ultrasonography |
| Estimated fetal weight | 20-26 weeks of gestation | Estimated fetal weight based on ultrasonography |
Countries
Indonesia
Outcome results
None listed