Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT02959125 |
Date of registration:
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27/08/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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NutFish and Nutrient Supplementation in Pregnancy Class to Improve Maternal and Birth Outcomes
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Scientific title:
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NutFish and Nutrient Supplementation in Pregnancy Class to Improve Maternal and Birth Outcomes |
Date of first enrolment:
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December 12, 2016 |
Target sample size:
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72 |
Recruitment status: |
Active, not recruiting |
URL:
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https://clinicaltrials.gov/show/NCT02959125 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Indonesia
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Contacts
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Name:
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Kun A Susiloretni, Dr |
Address:
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Telephone:
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Email:
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Affiliation:
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Semarang Health Polytechnic |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- First trimester of pregnancy
- Anemic or Mid Upper Arm Circumference < 23.5cm or no weight gain
- Plan to deliver at village midwives
- residence in the study area
Exclusion Criteria:
- severe anemia < 7.0g/dl
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Protein-Energy Malnutrition
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Anemia
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Pregnancy
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Intervention(s)
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Other: NutFish Based Food Supplementation
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Other: Government Food Supplementation
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Dietary Supplement: Multiple micronutrients
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Behavioral: Health Education in Pregnancy Class
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Dietary Supplement: Fe Supplementation
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Primary Outcome(s)
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Birth weight
[Time Frame: at delivery]
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Secondary Outcome(s)
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Birth length
[Time Frame: at delivery]
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Problems experience
[Time Frame: baseline, 30 (+/- 3), and 60 (+/- 3) days]
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Gestational weight gain
[Time Frame: baseline, 30 (+/- 3), and 60 (+/- 3) days]
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Mid upper arm circumference
[Time Frame: baseline, 30 (+/- 3), and 60 (+/- 3) days]
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Preterm birth
[Time Frame: at delivery]
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APGAR score
[Time Frame: at delivery]
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Dietary intake
[Time Frame: baseline, 30 (+/- 3), and 60 (+/- 3) days]
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Secondary ID(s)
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SemarangHP
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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