Effects of Snakehead Fish on IUGR and LBW Among Second and Third Trimester Women

Not Applicable

Completed

• Conditions: Pregnancy Related

• Registration Number: NCT07005609
• Lead Sponsor: Gadjah Mada University

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.

Study Timeline

• Study Start: 2021-06-01
• Primary Completion: 2021-11-11
• Study Completion: 2021-11-11
• Status Verified: 2025-02
• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-06-04
• Last Update Submitted: 2025-06-04
• Study First Posted: 2025-06-05
• Last Update Posted: 2025-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Obstetric and Gynecology Department, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada; 🇮🇩 Sleman, Yogyakarta, Indonesia