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

Dr Cipto Mangunkusumo General Hospital

Status: Active, not recruiting

Conditions: Nutrient Element Deficiency; High Risk Pregnancy; Pregnancy Related; Angiogenesis; Fetal Weight

Treatments: Dietary Supplement: Multiple Micronutrients; Drug: Standard Antenatal Vitamin

Study type: Interventional

Funder types: Other

Identifiers

NCT06929793

24081311

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Description:

1. Multiple micronutrient 2. Calcium Carbonat 766 mg 3. Vitamin D3 5000 IU 4. DHA 300 mg

Treatment:

Dietary Supplement: Multiple Micronutrients

Control

Placebo Comparator group

Description:

Standard antenatal vitamins

Treatment:

Drug: Standard Antenatal Vitamin