Nutrition Optimalization Among Pregnant Women to Improve Maternal and Neonatal Outcome in DKI Jakarta
NCT06268509 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 245
Last updated 2024-02-20
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
Conditions
- Pregnancy Complications
- Maternal Death
- Preeclampsia
- Intrauterine Infection
- Pregnancy Hemorrhage
- Preterm Birth
- Neonatal Death
- Low; Birthweight, Extremely (999 Grams or Less)
- Asphyxia Neonatorum
- IUGR
Interventions
- 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
Sponsors & Collaborators
-
Dinas Kesehatan DKI Jakarta
collaborator UNKNOWN -
Fakultas Kedokteran Universitas Indonesia
collaborator OTHER -
Dr Cipto Mangunkusumo General Hospital
lead OTHER
Principal Investigators
-
Rinawati Rohsiswatmo, Prof., M.D., Ph.D. · Dr Cipto Mangunkusumo Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-01
- Primary Completion
- 2024-06-30
- Completion
- 2024-08-31
Countries
- Indonesia
Study Locations
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