Multiple Micronutrients Supplementation on Angiogenesis and Vasculogenesis Factors, and Fetal Biometry

N/AActive Not RecruitingNCT06929793

Dr Cipto Mangunkusumo General Hospital200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

200

Conditions

Angiogenesis Fetal Weight Pregnancy Related Nutrient Element Deficiency

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

PlGF levels

Examination of angiogenesis factors in both research groups, using venous blood to measure Placental Growth Factor (PlGF) levels

Time frame: It was carried out at gestational age: 1. Trimester 1: 8-14 weeks. 2. Trimester 2: 20-26 weeks.

sFlt-1/PlGF ratio

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),

Time frame: 20-26 weeks of gestation

mean pulsatility index of uterine artery

Examination of vasculogenesis factors by measuring the mean Pulsatility Index of bilateral uterine arteries

Time frame: 1. Trimester 1 : 8-14 weeks. 2. Trimester 2 : 20-26 weeks.

Head circumference

Head circumference based on ultrasonography

Time frame: 20-26 weeks of gestation

Femur length

Femur length based on ultrasonography

Time frame: 20-26 weeks of gestation

Estimated fetal weight

Estimated fetal weight based on ultrasonography

Time frame: 20-26 weeks of gestation

Multiple Micronutrients Supplementation on Angiogenesis and Vasculogenesis Factors, and Fetal Biometry

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes