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

Not Applicable

Recruiting

• Conditions: Maternal Care Patterns; Maternal Outcome; Maternal-Fetal Relations; Nutrition, Healthy; Nutritional Deficiency; Perinatal Outcome
• Interventions: Dietary Supplement: Multiple Micronutrients during pregnancy

• Registration Number: NCT06035315
• Lead Sponsor: Dr Cipto Mangunkusumo General Hospital

Brief Summary

To monitor the effects of multi micronutrients supplementations during pregnancy towards pregnancy outcomes

Detailed Description

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.

Study Timeline

• Study Start: 2023-05-01
• Status Verified: 2023-09
• Study First Submitted: 2023-09-06
• Study First Submitted QC: 2023-09-06
• Last Update Submitted: 2023-09-06
• Study First Posted: 2023-09-13
• Last Update Posted: 2023-09-13
• Primary Completion: 2024-05-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventions	Multiple Micronutrients during pregnancy	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)

Primary Outcome Measures

Name	Time	Method
Maternal Outcome	1 year	Maternal Death; Preterm Delivery; Preeclampsia; Intrauterine Infections; Post partum hemorrhage
Perinatal Outcome	1 year	Neonatal death; Low birth weight; Intra uterine growth restriction; Asphyxia

Trial Locations

Locations (1)

Cipto Mangunkusumo General Hospital; 🇮🇩 Jakarta, Indonesia