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Clinical Trials/NCT06035315
NCT06035315
Recruiting
Not Applicable

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

Dr Cipto Mangunkusumo General Hospital1 site in 1 country240 target enrollmentMay 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Maternal Care Patterns
Sponsor
Dr Cipto Mangunkusumo General Hospital
Enrollment
240
Locations
1
Primary Endpoint
Maternal Outcome
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2023
End Date
August 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Dr Cipto Mangunkusumo General Hospital
Responsible Party
Principal Investigator
Principal Investigator

Rima Irwinda

MD, OBGYN, PhD

Dr Cipto Mangunkusumo General Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Maternal Outcome

Time Frame: 1 year

Maternal Death; Preterm Delivery; Preeclampsia; Intrauterine Infections; Post partum hemorrhage

Perinatal Outcome

Time Frame: 1 year

Neonatal death; Low birth weight; Intra uterine growth restriction; Asphyxia

Study Sites (1)

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