Maternal Care PatternsNCT06035315
The 1000 First Day of Life : Effect of Multi Micronutrients Supplementation on Pregnancy Outcomes
A study testing Multiple Micronutrients during pregnancy in people with Maternal Care Patterns and Nutrition, Healthy, run by Dr Cipto Mangunkusumo General Hospital at 2 sites in Indonesia.
Trial summary
To monitor the effects of multi micronutrients supplementations during pregnancy towards pregnancy outcomes Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Care Patterns, Nutrition, Healthy, Nutritional Deficiency
- What is being tested?
- Multiple Micronutrients during pregnancy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesIndonesia
- Study dates
- 1 May 2023to 31 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 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- First trimester pregnancy
- Gestational age < 10 weeks gestation
- Agree as research participant
- Living in DKI Jakarta
Who cannot join
- Assisted Reproductive
- History of PCOS
- History of Chronic Hypertension
- History of Diabetes Mellitus
- History of Preeclampsia
- Maternal chronic disease : Cardiovascular disease; Autoimmune condition; Malignancy)
- Plan to move from Jakarta prior or during pregnancy
- History of Recurrent pregnancy loss
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites, 2 recruiting
- Recruiting
Cipto Mangunkusumo General Hospital
Jakarta, 10430
Rima Irwinda, PhD, +62 812-9044-604, rima.irwinda@yahoo.com
Amanda Rumondang, Obstetricians Gynecologist, +62 81318375211, amanda17.md@gmail.com
- Recruiting
Cipto Mangunkusumo General Hospital
Jakarta Pusat, DKI Jakarta, 10430
Rima Irwinda, PhD, +62 812-9044-604, rima.irwinda@yahoo.com
Amanda Rumondang, Obstetrician Gynecologist, +62 813 18375211, amanda17.md@gmail.com
About this study
To monitor the effects of multi micronutrients supplementations during pregnancy towards pregnancy outcomes
Read the detailed description
A randomized control trial of two clusters :
1st cluster without giving multi micronutrients; 2nd cluster giving multi micronutrients.
Differences between cluster : Additional multi micronutrients by giving : Complete multi micronutrients, calcium, vitamin D and DHA. The additional multi micronutrients were given since 1st until 3rd trimester for interventions group. There are also additional laboratory examinations for intervention group : Vitamin D, Lipid Profile and Zinc level.
In control group : we use standard public health care micronutrients (Iron supplementation and calcium); and standard blood examinations.
Ultrasound examination was performed for both cluster since 1st until 3rd trimester.
- Conditions
- Maternal Care Patterns, Nutrition, Healthy, Nutritional Deficiency, Maternal-Fetal Relations, Perinatal Outcome, Maternal Outcome
- Being tested
- Multiple Micronutrients during pregnancy
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple Micronutrients during pregnancyDietary supplement
Pregnant women examine since 8 weeks gestation are being followed until delivery; are given additional micronutrients (Complete multi micronutrients-Calcium-Vitamin D-DHA); and perform ultrasound examinations each trimester and additional laboratory examination (Vitamin D level-Lipid profile-Zinc)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Pregnant women examine since 8 weeks gestation are being followed until delivery; are given government micronutrients; and perform ultrasound examinations each trimester and regular laboratory examination. |
| Interventions | Active comparator | Pregnant women examine since 8 weeks gestation are being followed until delivery; are given additional micronutrients (Complete multi micronutrients-Calcium-Vitamin D-DHA); and perform ultrasound examinations each trimester and additional laboratory examination (Vitamin D level-Lipid profile-Zinc) Receives: Dietary Supplement: Multiple Micronutrients during pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Outcome
Maternal Death; Preterm Delivery; Preeclampsia; Intrauterine Infections; Post partum hemorrhage
Measured: 1 year
Perinatal Outcome
Neonatal death; Low birth weight; Intra uterine growth restriction; Asphyxia
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 May 2023
- Primary completion31 May 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal Care PatternsStudies 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
- Model description
- Randomized control trial : comparison of two clusters
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rima Irwinda, Dr Cipto Mangunkusumo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035315
- Sponsor's protocol ID
- 23-02-0259
- Status last verified
- Sep 2023
- First submitted
- 6 Sep 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 1000 First Day of Life : Effect of Multi Micronutrients Supplementation on Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT06035315
- Acronym / sponsor ID
- 23-02-0259
- Conditions
- Maternal Care Patterns, Nutrition, Healthy, Nutritional Deficiency, Maternal-Fetal Relations, Perinatal Outcome, Maternal Outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 13 Sep 2023 (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.
To monitor the effects of multi micronutrients supplementations during pregnancy towards pregnancy outcomes
Detailed description
A randomized control trial of two clusters :
1st cluster without giving multi micronutrients; 2nd cluster giving multi micronutrients.
Differences between cluster : Additional multi micronutrients by giving : Complete multi micronutrients, calcium, vitamin D and DHA. The additional multi micronutrients were given since 1st until 3rd trimester for interventions group. There are also additional laboratory examinations for intervention group : Vitamin D, Lipid Profile and Zinc level.
In control group : we use standard public health care micronutrients (Iron supplementation and calcium); and standard blood examinations.
Ultrasound examination was performed for both cluster since 1st until 3rd trimester.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control trial : comparison of two clusters
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Pregnant women examine since 8 weeks gestation are being followed until delivery; are given government micronutrients; and perform ultrasound examinations each trimester and regular laboratory examination. |
| Interventions | Active comparator | Dietary Supplement: Multiple Micronutrients during pregnancyPregnant women examine since 8 weeks gestation are being followed until delivery; are given additional micronutrients (Complete multi micronutrients-Calcium-Vitamin D-DHA); and perform ultrasound examinations each trimester and additional laboratory examination (Vitamin D level-Lipid profile-Zinc) |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- First trimester pregnancy
- Gestational age < 10 weeks gestation
- Agree as research participant
- Living in DKI Jakarta
Key exclusion criteria (8 listed)
- Assisted Reproductive
- History of PCOS
- History of Chronic Hypertension
- History of Diabetes Mellitus
- History of Preeclampsia
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 |
|---|---|---|
| Multiple Micronutrients during pregnancyPregnant women examine since 8 weeks gestation are being followed until delivery; are given additional micronutrients (Complete multi micronutrients-Calcium-Vitamin D-DHA); and perform ultrasound examinations each trimester and additional laboratory examination (Vitamin D level-Lipid profile-Zinc) | Dietary supplement | Interventions |
Primary outcome
Maternal Outcome
Time frame: 1 year
Maternal Death; Preterm Delivery; Preeclampsia; Intrauterine Infections; Post partum hemorrhage
Perinatal Outcome
Time frame: 1 year
Neonatal death; Low birth weight; Intra uterine growth restriction; Asphyxia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple Micronutrients during pregnancy in people with Maternal Care Patterns and Nutrition, Healthy, run by Dr Cipto Mangunkusumo General Hospital at 2 sites 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 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Yurika Elizabeth, Medical Doctor (+62 8999979916, yurika.elizabeth.s@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Outcome (time frame: 1 year). 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 13 Sep 2023.