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

NCT06268509 | Recruiting DMC

• 1 other identifier: MONAS
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

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:

• 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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Diagnostic Test: Nutritional panel laboratory examination; Dietary Supplement: Pregnancy supplements (other than provided by Ministry of Health); Diagnostic Test: Fetomaternal ultrasound

Control group

NO INTERVENTION

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

Interventions

Nutritional panel laboratory examination DIAGNOSTIC_TEST

As stated in group description

Intervention group

Pregnancy supplements (other than provided by Ministry of Health) DIETARY_SUPPLEMENT

As stated in group description

Intervention group

Fetomaternal ultrasound DIAGNOSTIC_TEST

As stated in group description

Intervention group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnancy in 1st trimester
• Gestational age less than 10 weeks
• Living in Jakarta greater area
• Agree to participate

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dr Cipto Mangunkusumo General Hospital: lead
• Dinas Kesehatan DKI Jakarta: collaborator
• Fakultas Kedokteran Universitas Indonesia: collaborator

Study Sites (1)

Jakarta Primary Care Health Facility (Puskesmas) under Jakarta Health Office

Jakarta, Indonesia

RECRUITING

MeSH Terms

Conditions

Pregnancy Complications; Maternal Death; Pre-Eclampsia; Premature Birth; Perinatal Death; Birth Weight; Asphyxia Neonatorum

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Parental Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension, Pregnancy-Induced; Obstetric Labor, Premature; Obstetric Labor Complications; Body Weight; Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Rinawati Rohsiswatmo, Prof., M.D., Ph.D.

  Dr Cipto Mangunkusumo Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hardya G Hikmahrachim, M.D., M.Sc

CONTACT

+6281386696655; hardyagustada@yahoo.com

Yurika E Susanti, M.D.

CONTACT

yurika.elizabeth.s@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Member of Department of Child Health

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 20, 2024
• Study Start: April 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

ID (1)