The 1000 First Day of Life : Effect of Multi Micronutrients Supplementation on Pregnancy Outcomes
1 other identifier
interventional
240
1 country
2
Brief Summary
To monitor the effects of multi micronutrients supplementations during pregnancy towards pregnancy outcomes
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2023
CompletedFirst Submitted
Initial submission to the registry
September 6, 2023
CompletedFirst Posted
Study publicly available on registry
September 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedSeptember 13, 2023
September 1, 2023
1.1 years
September 6, 2023
September 6, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Control
NO INTERVENTIONPregnant 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.
Interventions
ACTIVE COMPARATORPregnant 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)
Interventions
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)
Eligibility Criteria
You may qualify if:
- First trimester pregnancy
- Gestational age \< 10 weeks gestation
- Agree as research participant
- Living in DKI Jakarta
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Cipto Mangunkusumo General Hospital
Jakarta Pusat, DKI Jakarta, 10430, Indonesia
Cipto Mangunkusumo General Hospital
Jakarta, 10430, Indonesia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, OBGYN, PhD
Study Record Dates
First Submitted
September 6, 2023
First Posted
September 13, 2023
Study Start
May 1, 2023
Primary Completion
May 31, 2024
Study Completion
August 31, 2024
Last Updated
September 13, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share