Clinical trial NCT04265391: Protein Supplementation of Snakehead Fish Cookies on Pregnant Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Keywords: snakehead fish cookies
intrauterine fetal growth
low birth weight
randomized controlled trial
protein supplementation
Lead sponsor: Gadjah Mada University
Sponsor class: OTHER
Collaborators: name: Indonesia-MoH
First posted: 2020-02-11
Enrollment: 50
Sex: FEMALE
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Estimated fetal weight (EFW)
timeFrame: change from baseline EFW after 1 month
measure: Biparietal diameter (BPD)
timeFrame: change from baseline BPD after 1 month
measure: Abdominal circumference (AC)
timeFrame: change from baseline AC after 1 month
measure: Femur length (FL)
timeFrame: change from baseline FL after 1 month
measure: Birth weight
timeFrame: immediately after the baby is born
measure: Birth length
timeFrame: immediately after the baby is born
Secondary outcomes:
Other outcomes:
Locations:
city: Sleman
country: Indonesia
facility: Public Health Center (Puskesmas) in the area of Sleman District
state: Yogyakarta
Study officials:
affiliation: Gadjah Mada University
name: Eugenius P Ganap, PhD
role: PRINCIPAL_INVESTIGATOR
References: