NutFish and Nutrient Supplementation in Pregnancy Class to Improve Maternal and Birth Outcomes
- Conditions
- PregnancyProtein-Energy MalnutritionAnemia
- Registration Number
- NCT02959125
- Lead Sponsor
- Semarang Health Polytechnic
- 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 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 72
- 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
- severe anemia < 7.0g/dl
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Birth weight at delivery Infant weight (in grams) at birth
- Secondary Outcome Measures
Name Time Method Preterm birth at delivery Delivery before 37 weeks gestation
Mid upper arm circumference 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 baseline, 30 (+/- 3), and 60 (+/- 3) days Weight gained during pregnancy as compared to medical recommendation
Dietary intake baseline, 30 (+/- 3), and 60 (+/- 3) days % nutrient intake compare to estimated average requirements (EAR). Dietary intake: energy, protein, zinc, Fe
Problems experience 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
APGAR score at delivery Five criteria used as an index of health in the immediate neonatal period : Appearance, Pulse, Grimace, Activity, Respiration
Birth length at delivery Infant length (in centimeters) at birth
Trial Locations
- Locations (2)
Demak District Health Office
🇮🇩Demak, Central Java, Indonesia
Public Health Center of Karangawen 2
🇮🇩Demak, Jawa Tengah, Indonesia
Demak District Health Office🇮🇩Demak, Central Java, Indonesia