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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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.


Sponsor: Semarang Health Polytechnic

Current Primary Outcome: Birth weight [ Time Frame: at delivery ]

Infant weight (in grams) at birth


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • APGAR score [ Time Frame: at delivery ]
    Five criteria used as an index of health in the immediate neonatal period : Appearance, Pulse, Grimace, Activity, Respiration
  • Preterm birth [ Time Frame: at delivery ]
    Delivery before 37 weeks gestation
  • Birth length [ Time Frame: at delivery ]
    Infant length (in centimeters) at birth
  • Mid upper arm circumference [ Time Frame: baseline, 30 (+/- 3), and 60 (+/- 3) days ]
    measured in centimeters, at the mid-point between the tip of the shoulder and the tip of the elbow
  • Gestational weight gain [ Time Frame: baseline, 30 (+/- 3), and 60 (+/- 3) days ]
    Weight gained during pregnancy as compared to medical recommendation
  • Dietary intake [ Time Frame: baseline, 30 (+/- 3), and 60 (+/- 3) days ]
    % nutrient intake compare to estimated average requirements (EAR). Dietary intake: energy, protein, zinc, Fe
  • Problems experience [ Time Frame: baseline, 30 (+/- 3), and 60 (+/- 3) days ]
    Number of problems(minor and serious) experience by the mother during pregnancy. Minor problems include: backache, constipation, cramp, feeling faint, hot, headache, etc. Serious problem: Slow-growing babies, Vaginal bleeding, Deep vein thrombosis, High blood pressure, pre-eclampsia, etc We will aggregate in minor and serious problems


Original Secondary Outcome:

  • APGAR score [ Time Frame: at delivery ]
    Five criteria used as an index of health in the immediate neonatal period : Appearance, Pulse, Grimace, Activity, Respiration
  • Preterm birth [ Time Frame: at delivery ]
    Delivery before 37 weeks gestation
  • Birth length [ Time Frame: at delivery ]
    Infant length (in centimeters) at birth
  • Mid upper arm circumference [ Time Frame: baseline, 30 (+/- 3), and 60 (+/- 3) days ]
    measured in centimeters, at the mid-point between the tip of the shoulder and the tip of the elbow
  • Gestational weight gain [ Time Frame: baseline, 30 (+/- 3), and 60 (+/- 3) days ]
    Weight gained during pregnancy as compared to medical recommendation
  • Dietary intake [ Time Frame: baseline, 30 (+/- 3), and 60 (+/- 3) days ]
    % nutrient intake compare to estimated average requirements (EAR). Dietary intake: energy, protein, zinc, Fe
  • Problems experience [ Time Frame: baseline, 30 (+/- 3), and 60 (+/- 3) days ]
    Number of problems(minor and serious) experience by the mother during pregnancy. Minor problems include: backache, constipation, cramp, feeling faint, hot, headache, etc. Serious problem: Slow-growing babies, Vaginal bleeding, Deep vein thrombosis, High blood pressure, pre-eclampsia, etc We will aggregated in minor and serious problems


Information By: Semarang Health Polytechnic

Dates:
Date Received: August 27, 2016
Date Started: November 2016
Date Completion: October 2017
Last Updated: November 16, 2016
Last Verified: November 2016