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

NCT ID: NCT07005609

Last Updated: 2025-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2021-11-11

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Snakehead Fish Meal Group

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.

Group Type EXPERIMENTAL

Snakehead fish meal

Intervention Type 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.

Control Group

Subjects in this group did not receive snakehead fish intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Snakehead fish meal

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Maximum Eligible Age

28 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role collaborator

Gadjah Mada University

OTHER

Sponsor Role lead

Responsible Party

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Eugenius Phyowai Ganap

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eugenius P Ganap, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Sleman, Special Region of Yogyakarta, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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Snakehead Fish Meal

Identifier Type: -

Identifier Source: org_study_id

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