Clinical trial NCT06268509: Nutrition Optimalization Among Pregnant Women to Improve Maternal and Neonatal Outcome in DKI Jakarta
Official title: Maternal Optimalization on Nutrition for Better Pregnancy Outcomes (MONAS Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Complications
Maternal Death
Preeclampsia
Intrauterine Infection
Pregnancy Hemorrhage
Preterm Birth
Neonatal Death
Low; Birthweight, Extremely (999 Grams or Less)
Asphyxia Neonatorum
IUGR
Lead sponsor: Dr Cipto Mangunkusumo General Hospital
Sponsor class: OTHER
Collaborators: name: Dinas Kesehatan DKI Jakarta
name: Fakultas Kedokteran Universitas Indonesia
First posted: 2024-02-20
Enrollment: 245
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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)

Primary outcomes:
measure: Composite of poor maternal outcomes
timeFrame: At anytime between 20 weeks of gestational age until 28 days after delivery
measure: Composite of poor neonatal outcomes
timeFrame: After delivery of participants (any gestational age) until 28 days of chronological age
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Jakarta Primary Care Health Facility (Puskesmas) under Jakarta Health Office
Study officials:
affiliation: Dr Cipto Mangunkusumo Hospital
name: Rinawati Rohsiswatmo, Prof., M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: