Nutrition Optimalization Among Pregnant Women to Improve Maternal and Neonatal Outcome in DKI Jakarta (MONAS)

February 16, 2024 updated by: Hardya Gustada Hikmahrachim, Dr Cipto Mangunkusumo General Hospital

Maternal Optimalization on Nutrition for Better Pregnancy Outcomes (MONAS Study)

The goal of this MONAS Study is to learn about comprehensive monitoring and nutritional intervention among pregnant women in order to improve maternal and neonatal outcomes. The main questions it aims to answer are:

  1. Are comprehensive monitoring and nutritional intervention among pregnant women can improve maternal outcomes (maternal death, preterm labour, preeclampsia, intrauterine infection, and bleeding during pregnancy and delivery) compared to standard maternal health services?
  2. Are comprehensive monitoring and nutritional intervention among pregnant women can improve neonatal outcomes (neonatal death, low birth weight, intrauterine growth restriction, and neonatal asphyxia) compared to standard maternal health services?

Participants in the intervention group will receive:

  • Fetomaternal ultrasound examination each trimester
  • Complete laboratory examination for nutritional panel (complete blood count with reticulocyte profile and iron profile, vitamin D level, zinc level, fatty acid profile, electrophoresis for Thalassemia) as an addition to standard maternal routine laboratory examination
  • Supplements: multivitamin, minerals, vitamin D, fatty acid
  • Intervention regarding any abnormal results of nutritional panel
  • All standard maternal health services according to Indonesian Ministry of Health protocol

Participants in the control group will receive:

- All standard maternal health services according to Indonesian Ministry of Health protocol

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

245

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Indonesia
      • Jakarta, Indonesia
        • Recruiting
        • Jakarta Primary Care Health Facility (Puskesmas) under Jakarta Health Office
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pregnancy in 1st trimester
  • Gestational age less than 10 weeks
  • Living in Jakarta greater area
  • Agree to participate

Exclusion Criteria:

  • Assisted reproductive technology (IVF)
  • History of polycystic ovary syndrome
  • History of chronic hypertension
  • History of diabetes mellitus
  • History of preeclampsia in the previous pregnancy
  • Had chronic disease: heart disease, autoimmune disease, malignancy, chronic lung disease
  • Planning to have delivery outside Jakarta greater area
  • Poor obstetric history (miscarriage/ abortion more than 3 times)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group

Participants in the intervention group will receive:

  • Fetomaternal ultrasound examination each trimester by fetomaternal consultants
  • Complete laboratory examination for nutritional panel (complete blood count with reticulocyte profile and iron profile, vitamin D level, zinc level, fatty acid profile, electrophoresis for Thalassemia) as an addition to standard maternal routine laboratory examination
  • Supplements: multivitamin, minerals, vitamin D, fatty acid
  • Intervention regarding any abnormal results of nutritional panel
  • All standard maternal health services according to Indonesian Ministry of Health protocol
Diagnostic test: Nutritional panel laboratory examination
As stated in group description
Dietary supplement: Pregnancy supplements (other than provided by Ministry of Health)
As stated in group description
Diagnostic test: Fetomaternal ultrasound
As stated in group description
No Intervention: Control group

Participants in the control group will receive:

- All standard maternal health services according to Indonesian Ministry of Health protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of poor maternal outcomes
Time Frame: At anytime between 20 weeks of gestational age until 28 days after delivery
Number of participants with a combination of maternal death, preterm labour, preeclampsia, intrauterine infection, and bleeding during pregnancy and or after delivery
At anytime between 20 weeks of gestational age until 28 days after delivery
Composite of poor neonatal outcomes
Time Frame: After delivery of participants (any gestational age) until 28 days of chronological age
A number of baby born from participants with a combination of neonatal death, low birth weight, intrauterine growth restriction, neonatal asphyxia, and need of admission to intensive care untill 28 daya of age
After delivery of participants (any gestational age) until 28 days of chronological age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Cipto Mangunkusumo General Hospital

Collaborators

Fakultas Kedokteran Universitas Indonesia
Dinas Kesehatan DKI Jakarta

Investigators

  • Principal Investigator: Rinawati Rohsiswatmo, Prof., M.D., Ph.D., Dr Cipto Mangunkusumo Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

February 16, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MONAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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