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

NCT07005609 | Completed

• 1 other identifier: Snakehead Fish Meal
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Keywords

Snakehead fish prepared-meal; Intrauterine growth restriction; Low birth weight; Randomized controlled trial

Outcome Measures

Primary Outcomes (8)

• 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)

  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.

Study Arms (2)

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.

Dietary Supplement: Snakehead fish meal

Control Group

NO INTERVENTION

Subjects in this group did not receive snakehead fish intervention.

Interventions

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.

Snakehead Fish Meal Group

Eligibility Criteria

• Age: Up to 28 Years
• Gender Eligibility Details: Subjects in this study were pregnant women in the second and third trimesters.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gadjah Mada University: lead
• National Institute of Health Research and Development, Ministry of Health Republic of Indonesia: collaborator

Study Sites (1)

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

Sleman, Special Region of Yogyakarta, 55281, Indonesia

Location

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

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

Study Officials

• Eugenius P Ganap, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: June 5, 2025
• Study Start: June 1, 2021
• Primary Completion: November 11, 2021
• Study Completion: November 11, 2021
• Last Updated: June 5, 2025

Record last verified: 2025-02

Locations

ID (1)