Nutrition Optimalization Among Pregnant Women to Improve Maternal and Neonatal Outcome in DKI Jakarta
NCT ID: NCT06268509
Last Updated: 2024-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
245 participants
INTERVENTIONAL
2023-04-01
2024-08-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention group
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
Nutritional panel laboratory examination
As stated in group description
Pregnancy supplements (other than provided by Ministry of Health)
As stated in group description
Fetomaternal ultrasound
As stated in group description
Control group
Participants in the control group will receive:
\- All standard maternal health services according to Indonesian Ministry of Health protocol
No interventions assigned to this group
Interventions
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Nutritional panel laboratory examination
As stated in group description
Pregnancy supplements (other than provided by Ministry of Health)
As stated in group description
Fetomaternal ultrasound
As stated in group description
Eligibility Criteria
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Inclusion Criteria
* Gestational age less than 10 weeks
* Living in Jakarta greater area
* Agree to participate
Exclusion Criteria
* 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)
FEMALE
No
Sponsors
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Dinas Kesehatan DKI Jakarta
UNKNOWN
Fakultas Kedokteran Universitas Indonesia
OTHER
Dr Cipto Mangunkusumo General Hospital
OTHER
Responsible Party
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Hardya Gustada Hikmahrachim
Principal Investigator, Member of Department of Child Health
Principal Investigators
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Rinawati Rohsiswatmo, Prof., M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Dr Cipto Mangunkusumo Hospital
Locations
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Jakarta Primary Care Health Facility (Puskesmas) under Jakarta Health Office
Jakarta, , Indonesia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MONAS
Identifier Type: -
Identifier Source: org_study_id
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