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NutFish and Nutrient Supplementation in Pregnancy Class to Improve Maternal and Birth Outcomes

Pregnancy Clinical Trial

Official title:
NutFish and Nutrient Supplementation in Pregnancy Class to Improve Maternal and Birth Outcomes

Clinical Trial Summary

This study evaluates the intervention of Nut Fish based food, micro nutrients supplementation and pregnancy class to improve maternal and birth outcome. This is cluster randomized trial with two arms. The intervention group will receive Nut Fish based supplementation, multiple micro nutrients, and pregnancy class. The control group will receive government food supplementation, iron folic acid supplementation, and pregnancy class.

Clinical Trial Description

Objectives: To investigate whether a nut fish based food and dietary supplementation delivered to pregnant mothers with health education would benefit maternal and birth outcomes compared with the government standard of care.

Design. A randomized control trial will be implemented in rural community in Indonesia.

Intervention. The 2 trial arms will be control group (government standard of care) and intervention group with nut fish based food and dietary supplementation and health education series in the pregnancy class. A control group will receive government food supplementation package, Iron Folic acid pills and pregnancy class. An intervention group will receive NutFish based food supplementation, multiple micro nutrients, and pregnancy class. As a pilot study, all the intervention packages will be delivered by research team members.

Subjects. A total 72 first trimester of pregnant mothers will be enrolled with 36 pregnant mothers each group.

Outcome measures. Maternal outcome at 1 and 2 month after intervention namely weight increment, energy and protein intake, mid upper arm circumference, and complications. Birth outcomes include APGAR score, birth weight and length, preterm birth.

Analysis. Linear, logistic and multinomial logistic regression. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02959125
Study type Interventional
Source Semarang Health Polytechnic
Contact
Status Active, not recruiting
Phase N/A
Start date December 12, 2016
Completion date December 20, 2017
View Details
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