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

Primary Purpose

Maternal Care Patterns, Nutrition, Healthy, Nutritional Deficiency

Status
Recruiting
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Multiple Micronutrients during pregnancy
Sponsored by
Dr Cipto Mangunkusumo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Maternal Care Patterns

Eligibility Criteria

15 Years - 45 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Cipto Mangunkusumo General HospitalRecruiting
  • Cipto Mangunkusumo General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Interventions

Arm Description

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.

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 6, 2023
Last Updated
September 6, 2023
Sponsor
Dr Cipto Mangunkusumo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06035315
Brief Title
The 1000 First Day of Life : Effect of Multi Micronutrients Supplementation on Pregnancy Outcomes
Official Title
The 1000 First Day of Life : Effect of Multi Micronutrients Supplementation on Pregnancy Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr Cipto Mangunkusumo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Care Patterns, Nutrition, Healthy, Nutritional Deficiency, Maternal-Fetal Relations, Perinatal Outcome, Maternal Outcome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial : comparison of two clusters
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Interventions
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Multiple Micronutrients during pregnancy
Intervention Description
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 Measure Information:
Title
Maternal Outcome
Description
Maternal Death; Preterm Delivery; Preeclampsia; Intrauterine Infections; Post partum hemorrhage
Time Frame
1 year
Title
Perinatal Outcome
Description
Neonatal death; Low birth weight; Intra uterine growth restriction; Asphyxia
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yurika Elizabeth, Medical Doctor
Phone
+62 8999979916
Email
yurika.elizabeth.s@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda Rumondang, Obstetrician Gynecologist
Phone
+62 81318375211
Email
amanda17.md@gmail.com
Facility Information:
Facility Name
Cipto Mangunkusumo General Hospital
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rima Irwinda, PhD
Phone
+62 812-9044-604
Email
rima.irwinda@yahoo.com
First Name & Middle Initial & Last Name & Degree
Amanda Rumondang, Obstetrician Gynecologist
Phone
+62 813 18375211
Email
amanda17.md@gmail.com
Facility Name
Cipto Mangunkusumo General Hospital
City
Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rima Irwinda, PhD
Phone
+62 812-9044-604
Email
rima.irwinda@yahoo.com
First Name & Middle Initial & Last Name & Degree
Amanda Rumondang, Obstetricians Gynecologist
Phone
+62 81318375211
Email
amanda17.md@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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