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| Name | Class |
|---|---|
| National Institute of Health Research and Development, Ministry of Health Republic of Indonesia | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Snakehead Fish Meal Group | Experimental | Subjects in this treatment group received snakehead fish prepared-meal for about 3 months until delivery. Snakehead fish was provided at an amount of +-100 grams per serving. |
|
| Control Group | No Intervention | Subjects in this group did not receive snakehead fish intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Snakehead fish meal | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Snakehead fish intake | 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. | Snakehead fish intake were noted using food record every day for about 3 months. |
| Estimated Fetal Weight (EFW) | Primary outcomes measured in this study were fetal growth. One of the fetal growth indicator was estimated fetal weight (EFW), reported in grams. | 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. |
| Femur length (FL) | Femur length was also one of the fetal growth indicator measured in this study. It was noted in centimeters. | Femur length was measured 3 times using 2D-Ultrasound once every 4 weeks, around week 1, week 5, and week 9 of the study. |
| Biparietal diameter (BPD) | Biparietal diameter was also measured along with EFW and FL, reported in centimeters. | Biparietal diamter was measured 3 times using 2D-Ultrasound once every 4 weeks, around week 1, week 5, and week 9 of the study. |
| Head circumference (HC) | Head circumference of the baby was also measured in this study. It is noted in centimeters. | Head 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 (AC) |
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Inclusion Criteria:
Exclusion Criteria:
Subjects in this study were pregnant women in the second and third trimesters.
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| Name | Affiliation | Role |
|---|---|---|
| Eugenius P Ganap, PhD | Department of Obstetric and Gynecology, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obstetric and Gynecology Department, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada | Sleman | Special Region of Yogyakarta | 55281 | Indonesia |
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| ID | Term |
|---|---|
| D005317 | Fetal Growth Retardation |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Abdominal circumference was another fetal growth indicator that also be measured during this study, and was reported in centimeters.
| Abdominal circumference was measured 3 times using 2D-Ultrasound once every 4 weeks, around week 1, week 5, and week 9 of the study. |
| Birth weight | Baby's birth weight data were collected from the mother and child's health book. | at the end of the study completion (after the baby is born), after an average of 3 months. |
| Birth length | Baby's birth length data were collected from the mother and child's health book. | at the end of the study completion (after the baby is born), after an average of 3 months. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |