Pregnancy Related
Conditions
Keywords
Snakehead fish prepared-meal, Intrauterine growth restriction, Low birth weight, Randomized controlled trial
Brief summary
This study uses a Randomized Controlled Trial (RCT) design, conducted on pregnant women in Yogyakarta Province, Indonesia. This study aims to observe the effects of snakehead fish prepared-meal intervention on fetal growth measurement and birth outcomes. The subjects were randomly divided into two groups (random allocation), the treatment and control groups. Subjects in the treatment group will be given supplementation of snakehead fish prepared-meal for lunch for 3 months daily, while subjects in the control group will not receive the intervention.
Detailed description
Subjects in this study were divided into two groups; treatment group, who were given snakehead fish prepared-meal for lunch everyday, and control group who were not given any supplementation.All participants have already agreed to join this study by signing the informed consent at the beginning of the study. Snakehead fish meal contained carbohydrate, protein (from snakehead fish), vegetables and fruit. The daily intake of snakehead fish meal were noted in the food record form independently by the subjects in the treatment group and would be reported periodically to the researcher. Snakehead fish meal were given for about 3 months or until the mother deliver the baby. All participants in both group were examined once a month using 2D ultrasonography to measured fetal growth. After the baby was born, baby's birth weigth and birth length data were obtained through the mother and baby's health book.
Interventions
DIETARY_SUPPLEMENTSnakehead fish meal
Subjects in the treatment group received snakehead fish meal daily for about 3 months until delivery. The meal contained carbohydrate, protein, vegetables and fruits. Snakehead fish was given +- 100 g per serving.
Sponsors
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
Gadjah Mada University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 28 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age ≤ 28 years 2. In the 2nd and 3rd trimesters 3. Middle to lower economic status
Exclusion criteria
1. Anemia 2. Preeclampsia 3. Multiple gestational pregnancy 4. Allergies to fish
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal circumference (AC) | Abdominal circumference was measured 3 times using 2D-Ultrasound once every 4 weeks, around week 1, week 5, and week 9 of the study. | Abdominal circumference was another fetal growth indicator that also be measured during this study, and was reported in centimeters. |
| Birth weight | at the end of the study completion (after the baby is born), after an average of 3 months. | Baby's birth weight data were collected from the mother and child's health book. |
| Birth length | at the end of the study completion (after the baby is born), after an average of 3 months. | Baby's birth length data were collected from the mother and child's health book. |
| Snakehead fish intake | Snakehead fish intake were noted using food record every day for about 3 months. | The daily intake of snakehead fish meal of the treatment group were measured using Food Intake Record form. The intake of the meal were categorized as finished (100%), 3/4 (75%), 1/2 (50%), 1/4 (25%), not eaten at all (0%). The higher the intake, the better the acceptability of the snakehead fish meal. |
| Estimated Fetal Weight (EFW) | Estimated fetal weight was measured 3 times using 2D-Ultrasound once every 4 weeks, around week 1, week 5, and week 9 of the study. | Primary outcomes measured in this study were fetal growth. One of the fetal growth indicator was estimated fetal weight (EFW), reported in grams. |
| Femur length (FL) | Femur length was measured 3 times using 2D-Ultrasound once every 4 weeks, around week 1, week 5, and week 9 of the study. | Femur length was also one of the fetal growth indicator measured in this study. It was noted in centimeters. |
| Biparietal diameter (BPD) | Biparietal diamter was measured 3 times using 2D-Ultrasound once every 4 weeks, around week 1, week 5, and week 9 of the study. | Biparietal diameter was also measured along with EFW and FL, reported in centimeters. |
| Head circumference (HC) | Head circumference was measured 3 times using 2D-Ultrasound once every 4 weeks, around week 1, week 5, and week 9 of the study. | Head circumference of the baby was also measured in this study. It is noted in centimeters. |
Countries
Indonesia
Outcome results
None listed