An interventional study of Nutritional panel laboratory examination and Pregnancy supplements (other than provided by Ministry of Health) in Pregnancy Complications, Maternal Death and Preeclampsia, sponsored by Dr Cipto Mangunkusumo General Hospital. Recruiting at 1 site in Indonesia. Open to female participants. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by Dr Cipto Mangunkusumo General Hospital · Not applicable, Interventional, and Prevention
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:
Participants in the intervention group will receive:
Participants in the control group will receive:
411 studies on the registry are indexed under Pregnancy Complications; 113 are open to participants now.
This study's planned enrollment of 245 is above the median of 144 across 205 interventional studies indexed under Pregnancy Complications.
Browse Pregnancy Complications studies →Dr Cipto Mangunkusumo General Hospital is the lead sponsor of 39 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Participants in the control group will receive: - All standard maternal health services according to Indonesian Ministry of Health protocol
As stated in group description
As stated in group description
As stated in group description
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
Time frame: 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
Time frame: After delivery of participants (any gestational age) until 28 days of chronological age
Plan to share: Undecided
No publications or documents are linked to this record.
Started Apr 2023 (actual). Primary completion is estimated for Jun 2024, 14 months after the start.
Of 119 non-industry interventional studies with no phase under Pregnancy Complications, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 14 months is below that.
Counting every sponsor, half of 119 studies reached it within 26 months; a quarter within 12 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
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Dr Cipto Mangunkusumo General Hospital