Protein Supplementation of Snakehead Fish Cookies on Pregnant Women

Gadjah Mada University

Status: Completed

Conditions: Pregnancy Related

Treatments: Dietary Supplement: cookies

Study type: Interventional

Funder types: Other

Identifiers

NCT04265391

Snakehead fish cookies

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: Under 25 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Snakehead fish cookies

Experimental group

Description:

Subjects who were given intervention of snakehead fish cookies during the study period

Treatment:

Dietary Supplement: cookies

Standard cookies

Placebo Comparator group

Description:

Subjects who were in control group and received standard cookies

Treatment:

Dietary Supplement: cookies