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

Not Applicable

Recruiting

• Conditions: Preterm Birth; Neonatal Death; IUGR; Asphyxia Neonatorum; Maternal Death; Preeclampsia; Low; Birthweight, Extremely (999 Grams or Less); Pregnancy Complications; Intrauterine Infection; Pregnancy Hemorrhage
• Interventions: Diagnostic Test: Nutritional panel laboratory examination; Dietary Supplement: Pregnancy supplements (other than provided by Ministry of Health); Diagnostic Test: Fetomaternal ultrasound

• Registration Number: NCT06268509
• Lead Sponsor: Dr Cipto Mangunkusumo General Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-01
• Study First Submitted: 2024-01-30
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-16
• Last Update Submitted: 2024-02-16
• Study First Posted: 2024-02-20
• Last Update Posted: 2024-02-20
• Primary Completion: 2024-06
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 245

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Fetomaternal ultrasound	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
Intervention group	Nutritional panel laboratory examination	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
Intervention group	Pregnancy supplements (other than provided by Ministry of Health)	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

Primary Outcome Measures

Name	Time	Method
Composite of poor maternal outcomes	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
Composite of poor neonatal outcomes	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

Trial Locations

Locations (1)

Jakarta Primary Care Health Facility (Puskesmas) under Jakarta Health Office; 🇮🇩 Jakarta, Indonesia