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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06268509
Other study ID # MONAS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2023
Est. completion date August 2024

Study information

Verified date February 2024
Source Dr Cipto Mangunkusumo General Hospital
Contact Hardya G Hikmahrachim, M.D., M.Sc
Phone +6281386696655
Email hardyagustada@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 245
Est. completion date August 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Indonesia Jakarta Primary Care Health Facility (Puskesmas) under Jakarta Health Office Jakarta

Sponsors (3)

Lead Sponsor Collaborator
Dr Cipto Mangunkusumo General Hospital Dinas Kesehatan DKI Jakarta, Fakultas Kedokteran Universitas Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Composite of poor maternal outcomes 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
Primary Composite of poor neonatal outcomes 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
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