The 1000 First Day of Life : Effect of Multi Micronutrients Supplementation on Pregnancy Outcomes

Study Overview
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Brief Summary
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To monitor the effects of multi micronutrients supplementations during pregnancy towards pregnancy outcomes

Detailed Description
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A randomized control trial of two clusters : 1st cluster without giving multi micronutrients; 2nd cluster giving multi micronutrients. Differences between cluster : Additional multi micronutrients by giving : Complete multi micronutrients, calcium, vitamin D and DHA. The additional multi micronutrients were given since 1st until 3rd trimester for interventions group. There are also additional laboratory examinations for intervention group : Vitamin D, Lipid Profile and Zinc level. In control group : we use standard public health care micronutrients (Iron supplementation and calcium); and standard blood examinations. Ultrasound examination was performed for both cluster since 1st until 3rd trimester.

Official Title
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The 1000 First Day of Life : Effect of Multi Micronutrients Supplementation on Pregnancy Outcomes

Conditions
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Maternal Care Patterns, Nutrition, Healthy, Nutritional Deficiency, Maternal-Fetal Relations, Perinatal Outcome, Maternal Outcome

Intervention / Treatment
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* Dietary Supplement: Multiple Micronutrients during pregnancy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First trimester pregnancy Gestational age < 10 weeks gestation Agree as research participant Living in DKI Jakarta Exclusion Criteria: Assisted Reproductive History of PCOS History of Chronic Hypertension History of Diabetes Mellitus History of Preeclampsia Maternal chronic disease : Cardiovascular disease; Autoimmune condition; Malignancy) Plan to move from Jakarta prior or during pregnancy History of Recurrent pregnancy loss

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized control trial : comparison of two clusters
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Pregnant women examine since 8 weeks gestation are being followed until delivery; are given government micronutrients; and perform ultrasound examinations each trimester and regular laboratory examination. | |
| Active Comparator: Interventions<br>Pregnant women examine since 8 weeks gestation are being followed until delivery; are given additional micronutrients (Complete multi micronutrients-Calcium-Vitamin D-DHA); and perform ultrasound examinations each trimester and additional laboratory examination (Vitamin D level-Lipid profile-Zinc) | Dietary Supplement: Multiple Micronutrients during pregnancy<br>* Pregnant women examine since 8 weeks gestation are being followed until delivery; are given additional micronutrients (Complete multi micronutrients-Calcium-Vitamin D-DHA); and perform ultrasound examinations each trimester and additional laboratory examination (Vitamin D level-Lipid profile-Zinc)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Outcome | Maternal Death; Preterm Delivery; Preeclampsia; Intrauterine Infections; Post partum hemorrhage | 1 year | 
| Perinatal Outcome | Neonatal death; Low birth weight; Intra uterine growth restriction; Asphyxia | 1 year |