Skip to content

Protein Supplementation of Snakehead Fish Cookies on Pregnant Women

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04265391
Enrollment
50
Registered
2020-02-11
Start date
2019-07-03
Completion date
2019-12-02
Last updated
2020-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Related

Keywords

snakehead fish cookies, intrauterine fetal growth, low birth weight, randomized controlled trial, protein supplementation

Brief 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. 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.

Interventions

DIETARY_SUPPLEMENTcookies

Either snakehead fish cookies or standard cookies were given to subjects 75g per day.

Sponsors

Indonesia-MoH
CollaboratorOTHER_GOV
Gadjah Mada University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 25 Years
Healthy volunteers
Yes

Inclusion criteria

1. second and third trimester gestational age, 2. lower-class family with income under Sleman District minimum wage in 2019 (\< 1,701,000 Rupiah), 3. pregnant women of under 25 years old, and 4. high school graduate or below

Exclusion criteria

1. suffering from anemia, 2. experiencing preeclampsia, 3. having multiple gestational, and 4. allergic to fish, eggs, and chocolate.

Design outcomes

Primary

MeasureTime frameDescription
Birth weightimmediately after the baby is bornBirth weight of the baby
Birth lengthimmediately after the baby is bornBirth length of the baby
Estimated fetal weight (EFW)change from baseline EFW after 1 monthWe measured EFW monthly using 2D ultrasonography (USG) for each subjects
Biparietal diameter (BPD)change from baseline BPD after 1 monthWe measured BPD monthly using 2D ultrasonography (USG) for each subjects
Abdominal circumference (AC)change from baseline AC after 1 monthWe measured AC monthly using 2D ultrasonography (USG) for each subjects
Femur length (FL)change from baseline FL after 1 monthWe measured FL monthly using 2D ultrasonography (USG) for each subjects

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026