Pregnancy RelatedNCT04265391
Protein Supplementation of Snakehead Fish Cookies on Pregnant Women
A study testing cookies in people with Pregnancy Related, run by Gadjah Mada University at 1 site in Indonesia.
Trial summary
This study was randomized controlled trial study whose subjects were pregnant women in Sleman District, Yogyakarta, Indonesia. The aims of this study were to make snakehead fish cookies formula which can be well accepted by pregnant women and to observed its effect on fetal growth and birth weight and length. Read more about this study
- Who is it for?
- Ages Up to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- cookies
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIndonesia
- Study dates
- 3 Jul 2019to 2 Dec 2019
- 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 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- second and third trimester gestational age,
- lower-class family with income under Sleman District minimum wage in 2019 (< 1,701,000 Rupiah),
- pregnant women of under 25 years old, and
- high school graduate or below
Who cannot join
- suffering from anemia,
- experiencing preeclampsia,
- having multiple gestational, and
- allergic to fish, eggs, and chocolate.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Public Health Center (Puskesmas) in the area of Sleman District
Sleman, Special Region of Yogyakarta
About this study
Official title: Protein Supplementation of Snakehead Fish Cookies on Pregnant Women to Prevent Intrauterine Growth Restriction and Low Birth Weight in Sleman District, Yogyakarta Province, Indonesia: a Randomized Controlled Trial Study
This study was randomized controlled trial study whose subjects were pregnant women in Sleman District, Yogyakarta, Indonesia. The aims of this study were to make snakehead fish cookies formula which can be well accepted by pregnant women and to observed its effect on fetal growth and birth weight and length. It was hypothesized that snakehead fish cookies could prevent intrauterine fetal growth (IUGR) and low birth weight (LBW).
Subjects on this study were randomly allocated into two groups which were treatment and control group. Subjects in treatment group were given snakehead fish cookies, while subject in control group received standard cookies. The intervention period lasted until subjects delivered their babies.
Read the detailed description
Subjects were enrolled from Public Health Center (puskesmas) in Sleman District, Yogyakarta Province, Indonesia. Subjects were being explained about the study intervention and were given informed consent as an approval of joining this study. The intervention was given everyday as much as 75g cookies for several weeks period (until delivery). Examination on fetal growth was done every month for each subjects. Birth weight and length were collected after delivery from child health book record.
- Conditions
- Pregnancy Related
- Being tested
- cookies
- Keywords
- snakehead fish cookies, intrauterine fetal growth, low birth weight, randomized controlled trial, protein supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cookiesDietary supplement
Either snakehead fish cookies or standard cookies were given to subjects 75g per day.
| Study group | Role | What they receive |
|---|---|---|
| Snakehead fish cookies | Experimental | Subjects who were given intervention of snakehead fish cookies during the study period Receives: Dietary Supplement: cookies |
| Standard cookies | Placebo comparator | Subjects who were in control group and received standard cookies Receives: Dietary Supplement: cookies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated fetal weight (EFW)
We measured EFW monthly using 2D ultrasonography (USG) for each subjects
Measured: change from baseline EFW after 1 month
Biparietal diameter (BPD)
We measured BPD monthly using 2D ultrasonography (USG) for each subjects
Measured: change from baseline BPD after 1 month
Abdominal circumference (AC)
We measured AC monthly using 2D ultrasonography (USG) for each subjects
Measured: change from baseline AC after 1 month
Femur length (FL)
We measured FL monthly using 2D ultrasonography (USG) for each subjects
Measured: change from baseline FL after 1 month
Birth weight
Birth weight of the baby
Measured: immediately after the baby is born
Birth length
Birth length of the baby
Measured: immediately after the baby is born
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start3 Jul 2019
- Primary completion2 Dec 2019
- Study completion2 Dec 2019
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Collaborators
- Indonesia-MoH
- Responsible party
- Principal investigator, Eugenius Phyowai Ganap, Gadjah Mada University
- Investigators
- Eugenius P Ganap, PhD, Principal investigator, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265391
- Sponsor's protocol ID
- Snakehead fish cookies
- Status last verified
- Feb 2020
- First submitted
- 4 Feb 2020
- Last updated
- 11 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This research was supported by Ministry of Health of Indonesia, and all data collected in this study were subject to Indonesian Ministry of Health rights.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein Supplementation of Snakehead Fish Cookies on Pregnant Women to Prevent Intrauterine Growth Restriction and Low Birth Weight in Sleman District, Yogyakarta Province, Indonesia: a Randomized Controlled Trial Study
- ClinicalTrials.gov ID
- NCT04265391
- Acronym / sponsor ID
- Snakehead fish cookies
- Conditions
- Pregnancy Related
- Keywords
- snakehead fish cookies, intrauterine fetal growth, low birth weight, randomized controlled trial, protein supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Collaborators
- Indonesia-MoH
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 2 Dec 2019 (actual)
- Study completion
- 2 Dec 2019 (actual)
- First posted
- 11 Feb 2020 (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 was randomized controlled trial study whose subjects were pregnant women in Sleman District, Yogyakarta, Indonesia. The aims of this study were to make snakehead fish cookies formula which can be well accepted by pregnant women and to observed its effect on fetal growth and birth weight and length. It was hypothesized that snakehead fish cookies could prevent intrauterine fetal growth (IUGR) and low birth weight (LBW).
Subjects on this study were randomly allocated into two groups which were treatment and control group. Subjects in treatment group were given snakehead fish cookies, while subject in control group received standard cookies. The intervention period lasted until subjects delivered their babies.
Detailed description
Subjects were enrolled from Public Health Center (puskesmas) in Sleman District, Yogyakarta Province, Indonesia. Subjects were being explained about the study intervention and were given informed consent as an approval of joining this study. The intervention was given everyday as much as 75g cookies for several weeks period (until delivery). Examination on fetal growth was done every month for each subjects. Birth weight and length were collected after delivery from child health book record.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Snakehead fish cookies | Experimental | Dietary Supplement: cookiesSubjects who were given intervention of snakehead fish cookies during the study period |
| Standard cookies | Placebo comparator | Dietary Supplement: cookiesSubjects who were in control group and received standard cookies |
Who may qualify
- Ages
- Up to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- second and third trimester gestational age,
- lower-class family with income under Sleman District minimum wage in 2019 (< 1,701,000 Rupiah),
- pregnant women of under 25 years old, and
- high school graduate or below
Key exclusion criteria (4 listed)
- suffering from anemia,
- experiencing preeclampsia,
- having multiple gestational, and
- allergic to fish, eggs, and chocolate.
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 |
|---|---|---|
| cookiesEither snakehead fish cookies or standard cookies were given to subjects 75g per day. | Dietary supplement | Snakehead fish cookies, Standard cookies |
Primary outcome
Estimated fetal weight (EFW)
Time frame: change from baseline EFW after 1 month
We measured EFW monthly using 2D ultrasonography (USG) for each subjects
Biparietal diameter (BPD)
Time frame: change from baseline BPD after 1 month
We measured BPD monthly using 2D ultrasonography (USG) for each subjects
Abdominal circumference (AC)
Time frame: change from baseline AC after 1 month
We measured AC monthly using 2D ultrasonography (USG) for each subjects
Femur length (FL)
Time frame: change from baseline FL after 1 month
We measured FL monthly using 2D ultrasonography (USG) for each subjects
Birth weight
Time frame: immediately after the baby is born
Birth weight of the baby
Birth length
Time frame: immediately after the baby is born
Birth length of the baby
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 11 Feb 2020.
- Individual participant dataSharing planned: No. This research was supported by Ministry of Health of Indonesia, and all data collected in this study were subject to Indonesian Ministry of Health rights.
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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
Gadjah Mada University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cookies 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 4 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 11 Feb 2020. 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. Some participants in this study may receive a placebo. 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?
Estimated fetal weight (EFW) (time frame: change from baseline EFW after 1 month). The study lists 6 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 11 Feb 2020.