Pregnancy ComplicationsMONASNCT06268509
Nutrition Optimalization Among Pregnant Women to Improve Maternal and Neonatal Outcome in DKI Jakarta
A study testing Nutritional panel laboratory examination, Pregnancy supplements (other than provided by Ministry of Health) and Fetomaternal ultrasound in people with Pregnancy Complications and Maternal Death, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy Complications, Maternal Death, Preeclampsia
- What is being tested?
- Nutritional panel laboratory examination, Pregnancy supplements (other than provided by Ministry of Health) and Fetomaternal ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Apr 2023to Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnancy in 1st trimester
- Gestational age less than 10 weeks
- Living in Jakarta greater area
- Agree to participate
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Yurika E Susanti, M.D. contact
Indonesia1 site, 1 recruiting
- Recruiting
Jakarta Primary Care Health Facility (Puskesmas) under Jakarta Health Office
Jakarta
Risal, M.D., M.Sc., dinkes@jakarta.go.id
About this study
Official title: Maternal Optimalization on Nutrition for Better Pregnancy Outcomes (MONAS Study)
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:
- 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?
- 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?
Read more
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
- Being tested
- Nutritional panel laboratory examination, Pregnancy supplements (other than provided by Ministry of Health), Fetomaternal ultrasound
- Medical subject headings
- Pregnancy Complications, Maternal Death, Pre-Eclampsia, Premature Birth, Perinatal Death, Birth Weight, Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional panel laboratory examinationDiagnostic test
As stated in group description
Pregnancy supplements (other than provided by Ministry of Health)Dietary supplement
As stated in group description
Fetomaternal ultrasoundDiagnostic test
As stated in group description
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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 Receives: Diagnostic Test: Nutritional panel laboratory examination; Dietary Supplement: Pregnancy supplements (other than provided by Ministry of Health); Diagnostic Test: Fetomaternal ultrasound |
| Control group | No intervention | Participants in the control group will receive: - All standard maternal health services according to Indonesian Ministry of Health protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: After delivery of participants (any gestational age) until 28 days of chronological age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Apr 2023
- Primary completionJun 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 245 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dinas Kesehatan DKI Jakarta, Fakultas Kedokteran Universitas Indonesia
- Responsible party
- Principal investigator, Hardya Gustada Hikmahrachim, Dr Cipto Mangunkusumo General Hospital
- Investigators
- Rinawati Rohsiswatmo, Prof., M.D., Ph.D., Principal investigator, Dr Cipto Mangunkusumo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268509
- Sponsor's protocol ID
- MONAS
- Acronym
- MONAS
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Optimalization on Nutrition for Better Pregnancy Outcomes (MONAS Study)
- ClinicalTrials.gov ID
- NCT06268509
- Acronym / sponsor ID
- MONAS / MONAS
- Conditions
- Pregnancy Complications, Maternal Death, Preeclampsia, Intrauterine Infection, Pregnancy Hemorrhage, Preterm Birth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 245 participants (estimated)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Collaborators
- Dinas Kesehatan DKI Jakarta, Fakultas Kedokteran Universitas Indonesia
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Diagnostic Test: Nutritional panel laboratory examination, Dietary Supplement: Pregnancy supplements (other than provided by Ministry of Health), Diagnostic Test: Fetomaternal ultrasoundParticipants 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 |
| Control group | No intervention | –Participants in the control group will receive: - All standard maternal health services according to Indonesian Ministry of Health protocol |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnancy in 1st trimester
- Gestational age less than 10 weeks
- Living in Jakarta greater area
- Agree to participate
Key exclusion criteria (8 listed)
- Assisted reproductive technology (IVF)
- History of polycystic ovary syndrome
- History of chronic hypertension
- History of diabetes mellitus
- History of preeclampsia in the previous pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional panel laboratory examinationAs stated in group description | Diagnostic test | Intervention group |
| Pregnancy supplements (other than provided by Ministry of Health)As stated in group description | Dietary supplement | Intervention group |
| Fetomaternal ultrasoundAs stated in group description | Diagnostic test | Intervention group |
Primary outcome
Composite of poor maternal outcomes
Time frame: 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
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yurika E Susanti, M.D. contact
Rinawati Rohsiswatmo, Prof., M.D., Ph.D. principal investigator
Dr Cipto Mangunkusumo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional panel laboratory examination, Pregnancy supplements (other than provided by Ministry of Health) and Fetomaternal ultrasound in people with Pregnancy Complications and Maternal Death, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hardya G Hikmahrachim, M.D., M.Sc (+6281386696655, hardyagustada@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of poor maternal outcomes (time frame: At anytime between 20 weeks of gestational age until 28 days after delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.