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

Dr Cipto Mangunkusumo General Hospital

Status

Enrolling

Conditions

Neonatal Death

Pregnancy Complications

Preeclampsia

IUGR

Pregnancy Hemorrhage

Maternal Death

Asphyxia Neonatorum

Intrauterine Infection

Low; Birthweight, Extremely (999 Grams or Less)

Preterm Birth

Treatments

Diagnostic Test: Fetomaternal ultrasound

Diagnostic Test: Nutritional panel laboratory examination

Dietary Supplement: Pregnancy supplements (other than provided by Ministry of Health)

Study type

Interventional

Funder types

Other

Identifiers

NCT06268509

MONAS

Details and patient eligibility

About

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:

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?
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

Enrollment

245 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

245 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Pregnancy supplements (other than provided by Ministry of Health)

Diagnostic Test: Nutritional panel laboratory examination

Diagnostic Test: Fetomaternal ultrasound

Control group

No Intervention group

Description:

Participants in the control group will receive: - All standard maternal health services according to Indonesian Ministry of Health protocol