Clinical trial NCT06929793: Multiple Micronutrients Supplementation on Angiogenesis and Vasculogenesis Factors, and Fetal Biometry
Official title: Multiple Micronutrients Supplementation on Angiogenesis and Vasculogenesis Factors, and Fetal Biometry
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Angiogenesis
Fetal Weight
Pregnancy Related
Nutrient Element Deficiency
High Risk Pregnancy
Keywords: micronutrients
angiogenesis
vasculogenesis
fetal biometry
Lead sponsor: Dr Cipto Mangunkusumo General Hospital
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: PlGF levels
timeFrame: It was carried out at gestational age: 1. Trimester 1: 8-14 weeks. 2. Trimester 2: 20-26 weeks.
measure: sFlt-1/PlGF ratio
timeFrame: 20-26 weeks of gestation
measure: mean pulsatility index of uterine artery
timeFrame: 1. Trimester 1 : 8-14 weeks. 2. Trimester 2 : 20-26 weeks.
measure: Head circumference
timeFrame: 20-26 weeks of gestation
measure: Femur length
timeFrame: 20-26 weeks of gestation
measure: Estimated fetal weight
timeFrame: 20-26 weeks of gestation
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Maternal Fetal Medicine Division, Obstetric Gynecology Department Cipto Mangunkusumo General Hospital
state: DKI Jakarta
Study officials:
References: