Protein Supplementation of Snakehead Fish Cookies on Pregnant Women

Pregnancy Related Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04265391
• Other study ID #: Snakehead fish cookies
• Status: Completed
• Phase: N/A
• Start date: July 3, 2019
• Est. completion date: December 2, 2019

Study information

• Verified date: February 2020
• Source: Gadjah Mada University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2, 2019
• Est. primary completion date: December 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Birth Weight
• Pregnancy Related

Intervention

Dietary Supplement:
• cookies
Either snakehead fish cookies or standard cookies were given to subjects 75g per day.

Locations

Country	Name	City	State
Indonesia	Public Health Center (Puskesmas) in the area of Sleman District	Sleman	Yogyakarta

Sponsors (2)

Lead Sponsor	Collaborator
Gadjah Mada University	Ministry of Health, Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated fetal weight (EFW)	We measured EFW monthly using 2D ultrasonography (USG) for each subjects	change from baseline EFW after 1 month
Primary	Biparietal diameter (BPD)	We measured BPD monthly using 2D ultrasonography (USG) for each subjects	change from baseline BPD after 1 month
Primary	Abdominal circumference (AC)	We measured AC monthly using 2D ultrasonography (USG) for each subjects	change from baseline AC after 1 month
Primary	Femur length (FL)	We measured FL monthly using 2D ultrasonography (USG) for each subjects	change from baseline FL after 1 month
Primary	Birth weight	Birth weight of the baby	immediately after the baby is born
Primary	Birth length	Birth length of the baby	immediately after the baby is born