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Active, Not Recruiting

NCT Number: NCT06929793

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Angiogenesis Body Weight Fetal Weight High Risk Pregnancy Nutrient Element Deficiency Pathological Conditions, Signs and Symptoms Pregnancy Related Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maternal Fetal Medicine Division, Obstetric Gynecology Department Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Multiple micronutrients

Dietary Supplement
  • Multiple micronutrient
  • Calcium Carbonat 766 mg
  • Vitamin D3 5000 IU
  • DHA 300 mg

Standard Antenatal Vitamin

Drug

Standard Antenatal Vitamin given in Community Health Centers

Primary outcomes

  1. PlGF levels

    Time frame: 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

  2. sFlt-1/PlGF ratio

    Time frame: 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),

  3. mean pulsatility index of uterine artery

    Time frame: 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

  4. Head circumference

    Time frame: 20-26 weeks of gestation

    Head circumference based on ultrasonography

  5. Femur length

    Time frame: 20-26 weeks of gestation

    Femur length based on ultrasonography

  6. Estimated fetal weight

    Time frame: 20-26 weeks of gestation

    Estimated fetal weight based on ultrasonography

Sponsors and collaborators

Lead sponsor

Dr Cipto Mangunkusumo General Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 16, 2025
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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