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

Preterm Birth Clinical Trial

— MONAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06268509
• Other study ID #: MONAS
• Status: Recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum
• Birth Weight
• Death
• Hemorrhage
• IUGR
• Low; Birthweight, Extremely (999 Grams or Less)
• Maternal Death
• Neonatal Death
• Perinatal Death
• Pre-Eclampsia
• Preeclampsia
• Pregnancy Complications
• Pregnancy Hemorrhage
• Preterm Birth

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