Asphyxia Neonatorum, Intrauterine Infection, IUGR, Low; Birthweight, Extremely (999 Grams or Less), Maternal Death, Neonatal Death, Preeclampsia, Pregnancy Complications, Pregnancy Hemorrhage, Preterm Birth
Conditions
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
Interventions
DIAGNOSTIC_TESTNutritional panel laboratory examination
As stated in group description
DIETARY_SUPPLEMENTPregnancy supplements (other than provided by Ministry of Health)
As stated in group description
DIAGNOSTIC_TESTFetomaternal ultrasound
As stated in group description
Sponsors
Dinas Kesehatan DKI Jakarta
Fakultas Kedokteran Universitas Indonesia
Dr Cipto Mangunkusumo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Indonesia
Contacts
Primary ContactHardya G Hikmahrachim, M.D., M.Sc
Backup ContactYurika E Susanti, M.D.
Outcome results
None listed