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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02959125
• Other study ID #: SemarangHP
• Status: Active, not recruiting
• Phase: N/A
• First received: August 27, 2016
• Last updated: October 22, 2017
• Start date: December 12, 2016
• Est. completion date: December 20, 2017

Study information

• Verified date: October 2017
• Source: Semarang Health Polytechnic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: December 20, 2017
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Malnutrition
• Pregnancy
• Protein-Energy Malnutrition

Intervention

Other:
• NutFish Based Food Supplementation
Cookies contain 500 Calories and 15 gram protein make from nut and ocean fish

Dietary Supplement:
• Multiple micronutrients
Vitamin A 5000 iu, vitamin D 400 iu, vitamin C 100 mg, vitamin B1 7.5 mg, vitamin B2 3 mg, vitamin B6 10 mg, vitamin B12 10 mcg, fluoride 1 mg, Fe fumarate 91 mg, niacinamide 20 mg, Ca pantothenate 7.5 mg, folic acid 400 mcg, Zn 5 mg, Ca lactate 250 mg, copper 0.1 mg, iodine 0.1 mg

Behavioral:
• Health Education in Pregnancy Class
Health education on pregnancy, complication, and breastfeeding by research team members

Other:
• Government Food Supplementation
Cookies contain 500 Calories and 5 gram protein make from flour and egg

Dietary Supplement:
• Fe Supplementation
Ferrous Fumarate 60mg and folic acid 0.400 mg

Locations

Country	Name	City	State
Indonesia	Demak District Health Office	Demak	Central Java
Indonesia	Public Health Center of Karangawen 2	Demak	Jawa Tengah

Sponsors (1)

Lead Sponsor	Collaborator
Semarang Health Polytechnic

Country where clinical trial is conducted

Indonesia, 

References & Publications (3)

Haider BA, Bhutta ZA. Multiple-micronutrient supplementation for women during pregnancy. Cochrane Database Syst Rev. 2015 Nov 1;(11):CD004905. doi: 10.1002/14651858.CD004905.pub4. Review. Update in: Cochrane Database Syst Rev. 2017 Apr 13;4:CD004905. — View Citation

Imdad A, Bhutta ZA. Maternal nutrition and birth outcomes: effect of balanced protein-energy supplementation. Paediatr Perinat Epidemiol. 2012 Jul;26 Suppl 1:178-90. doi: 10.1111/j.1365-3016.2012.01308.x. Review. — View Citation

Ota E, Hori H, Mori R, Tobe-Gai R, Farrar D. Antenatal dietary education and supplementation to increase energy and protein intake. Cochrane Database Syst Rev. 2015 Jun 2;(6):CD000032. doi: 10.1002/14651858.CD000032.pub3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Birth weight	Infant weight (in grams) at birth	at delivery
Secondary	APGAR score	Five criteria used as an index of health in the immediate neonatal period : Appearance, Pulse, Grimace, Activity, Respiration	at delivery
Secondary	Preterm birth	Delivery before 37 weeks gestation	at delivery
Secondary	Birth length	Infant length (in centimeters) at birth	at delivery
Secondary	Mid upper arm circumference	measured in centimeters, at the mid-point between the tip of the shoulder and the tip of the elbow	baseline, 30 (+/- 3), and 60 (+/- 3) days
Secondary	Gestational weight gain	Weight gained during pregnancy as compared to medical recommendation	baseline, 30 (+/- 3), and 60 (+/- 3) days
Secondary	Dietary intake	% nutrient intake compare to estimated average requirements (EAR). Dietary intake: energy, protein, zinc, Fe	baseline, 30 (+/- 3), and 60 (+/- 3) days
Secondary	Problems experience	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	baseline, 30 (+/- 3), and 60 (+/- 3) days