Clinical trial NCT07005609: Effects of Snakehead Fish on IUGR and LBW Among Second and Third Trimester Women
Official title: Effects of Snakehead Fish as an Alternative High-Protein Food Source on Intrauterine Growth Restriction and Low Birth Weight Among Pregnant Women in Their Second and Third Trimesters Within Yogyakarta Province
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Keywords: Snakehead fish prepared-meal
Intrauterine growth restriction
Low birth weight
Randomized controlled trial
Lead sponsor: Gadjah Mada University
Sponsor class: OTHER
Collaborators: name: National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
First posted: 2025-06-05
Enrollment: 56
Sex: FEMALE
Maximum age (years): 28
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Snakehead fish intake
timeFrame: Snakehead fish intake were noted using food record every day for about 3 months.
measure: Estimated Fetal Weight (EFW)
timeFrame: 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.
measure: Femur length (FL)
timeFrame: Femur length was measured 3 times using 2D-Ultrasound once every 4 weeks, around week 1, week 5, and week 9 of the study.
measure: Biparietal diameter (BPD)
timeFrame: Biparietal diamter was measured 3 times using 2D-Ultrasound once every 4 weeks, around week 1, week 5, and week 9 of the study.
measure: Head circumference (HC)
timeFrame: Head circumference was measured 3 times using 2D-Ultrasound once every 4 weeks, around week 1, week 5, and week 9 of the study.
measure: Abdominal circumference (AC)
timeFrame: Abdominal circumference was measured 3 times using 2D-Ultrasound once every 4 weeks, around week 1, week 5, and week 9 of the study.
measure: Birth weight
timeFrame: at the end of the study completion (after the baby is born), after an average of 3 months.
measure: Birth length
timeFrame: at the end of the study completion (after the baby is born), after an average of 3 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Sleman
country: Indonesia
facility: Obstetric and Gynecology Department, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada
state: Yogyakarta
Study officials:
affiliation: Department of Obstetric and Gynecology, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia
name: Eugenius P Ganap, PhD
role: PRINCIPAL_INVESTIGATOR
References: