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

NCT06268509 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2024-02-20

No results posted yet for this study

Summary

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

Conditions

  • Pregnancy Complications
  • Maternal Death
  • Preeclampsia
  • Intrauterine Infection
  • Pregnancy Hemorrhage
  • Preterm Birth
  • Neonatal Death
  • Low; Birthweight, Extremely (999 Grams or Less)
  • Asphyxia Neonatorum
  • IUGR

Interventions

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

Sponsors & Collaborators

  • Dinas Kesehatan DKI Jakarta

    collaborator UNKNOWN
  • Fakultas Kedokteran Universitas Indonesia

    collaborator OTHER
  • Dr Cipto Mangunkusumo General Hospital

    lead OTHER

Principal Investigators

  • Rinawati Rohsiswatmo, Prof., M.D., Ph.D. · Dr Cipto Mangunkusumo Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2024-06-30
Completion
2024-08-31

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06268509 on ClinicalTrials.gov