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NCT Number: NCT07005609

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

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.

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Key information

Conditions

Pregnancy Related Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Growth Retardation Growth Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases

Age range

Up to 28 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Obstetric and Gynecology Department, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada

Sleman, Special Region of Yogyakarta, 55281, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≤ 28 years
  • In the 2nd and 3rd trimesters
  • Middle to lower economic status

Exclusion criteria

  • Anemia
  • Preeclampsia
  • Multiple gestational pregnancy
  • Allergies to fish

Treatment and study plan

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.

Primary outcomes

  1. Snakehead fish intake

    Time frame: 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.

  2. Estimated Fetal Weight (EFW)

    Time frame: 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.

  3. Femur length (FL)

    Time frame: 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.

  4. Biparietal diameter (BPD)

    Time frame: 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.

  5. Head circumference (HC)

    Time frame: 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.

  6. Abdominal circumference (AC)

    Time frame: 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.

  7. Birth weight

    Time frame: 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.

  8. Birth length

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gadjah Mada University

Other

Collaborators

  • National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 5, 2025
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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