Pregnancy RelatedNCT07005609
Effects of Snakehead Fish on IUGR and LBW Among Second and Third Trimester Women
A study testing Snakehead fish meal in people with Pregnancy Related, run by Gadjah Mada University at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 28 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Snakehead fish meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jun 2021to 11 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age ≤ 28 years
- In the 2nd and 3rd trimesters
- Middle to lower economic status
Who cannot join
- Anemia
- Preeclampsia
- Multiple gestational pregnancy
- Allergies to fish
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Obstetric and Gynecology Department, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada
Sleman, Special Region of Yogyakarta, 55281
About this study
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
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.
Read the 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.
- Conditions
- Pregnancy Related
- Being tested
- Snakehead fish meal
- Keywords
- Snakehead fish prepared-meal, Intrauterine growth restriction, Low birth weight, Randomized controlled trial
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Snakehead fish mealDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Snakehead fish meal |
| Control Group | No intervention | Subjects in this group did not receive snakehead fish intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at the end of the study completion (after the baby is born), after an average of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start1 Jun 2021
- Primary completion11 Nov 2021
- Study completion11 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
- Responsible party
- Principal investigator, Eugenius Phyowai Ganap, Gadjah Mada University
- Investigators
- Eugenius P Ganap, PhD, Principal investigator, Department of Obstetric and Gynecology, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005609
- Sponsor's protocol ID
- Snakehead Fish Meal
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07005609
- Acronym / sponsor ID
- Snakehead Fish Meal
- Conditions
- Pregnancy Related
- Keywords
- Snakehead fish prepared-meal, Intrauterine growth restriction, Low birth weight, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Collaborators
- National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 11 Nov 2021 (actual)
- Study completion
- 11 Nov 2021 (actual)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Snakehead Fish Meal Group | Experimental | Dietary Supplement: Snakehead fish mealSubjects 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. |
| Control Group | No intervention | –Subjects in this group did not receive snakehead fish intervention. |
Who may qualify
- Ages
- Up to 28 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age ≤ 28 years
- In the 2nd and 3rd trimesters
- Middle to lower economic status
Key exclusion criteria (4 listed)
- Anemia
- Preeclampsia
- Multiple gestational pregnancy
- Allergies to fish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Snakehead fish mealSubjects 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. | Dietary supplement | Snakehead Fish Meal Group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugenius P Ganap, PhD principal investigator
Department of Obstetric and Gynecology, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Snakehead fish meal in people with Pregnancy Related, run by Gadjah Mada University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Snakehead fish intake (time frame: Snakehead fish intake were noted using food record every day for about 3 months.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.