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Completed

NCT Number: NCT04265391

Protein Supplementation of Snakehead Fish Cookies on Pregnant Women

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.

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Key information

Conditions

Pregnancy Related

Age range

Up to 25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Public Health Center (Puskesmas) in the area of Sleman District

Sleman, Special Region of Yogyakarta, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • suffering from anemia,
  • experiencing preeclampsia,
  • having multiple gestational, and
  • allergic to fish, eggs, and chocolate.

Treatment and study plan

cookies

Dietary Supplement

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

Primary outcomes

  1. Estimated fetal weight (EFW)

    Time frame: change from baseline EFW after 1 month

    We measured EFW monthly using 2D ultrasonography (USG) for each subjects

  2. Biparietal diameter (BPD)

    Time frame: change from baseline BPD after 1 month

    We measured BPD monthly using 2D ultrasonography (USG) for each subjects

  3. Abdominal circumference (AC)

    Time frame: change from baseline AC after 1 month

    We measured AC monthly using 2D ultrasonography (USG) for each subjects

  4. Femur length (FL)

    Time frame: change from baseline FL after 1 month

    We measured FL monthly using 2D ultrasonography (USG) for each subjects

  5. Birth weight

    Time frame: immediately after the baby is born

    Birth weight of the baby

  6. Birth length

    Time frame: immediately after the baby is born

    Birth length of the baby

Sponsors and collaborators

Lead sponsor

Gadjah Mada University

Other

Collaborators

  • Indonesia-MoH

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 11, 2020
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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