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Protein Supplementation of Snakehead Fish Cookies on Pregnant Women

Primary Purpose

Pregnancy Related

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
cookies
Sponsored by
Gadjah Mada University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy Related focused on measuring snakehead fish cookies, intrauterine fetal growth, low birth weight, randomized controlled trial, protein supplementation

Eligibility Criteria

undefined - 25 Years (Child, Adult)FemaleAccepts 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Snakehead fish cookies

Standard cookies

Arm Description

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

Subjects who were in control group and received standard cookies

Outcomes

Primary Outcome Measures

Estimated fetal weight (EFW)
We measured EFW monthly using 2D ultrasonography (USG) for each subjects
Biparietal diameter (BPD)
We measured BPD monthly using 2D ultrasonography (USG) for each subjects
Abdominal circumference (AC)
We measured AC monthly using 2D ultrasonography (USG) for each subjects
Femur length (FL)
We measured FL monthly using 2D ultrasonography (USG) for each subjects
Birth weight
Birth weight of the baby
Birth length
Birth length of the baby

Secondary Outcome Measures

Full Information

First Posted
February 4, 2020
Last Updated
February 9, 2020
Sponsor
Gadjah Mada University
Collaborators
Indonesia-MoH
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1. Study Identification

Unique Protocol Identification Number
NCT04265391
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 3, 2019 (Actual)
Primary Completion Date
December 2, 2019 (Actual)
Study Completion Date
December 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gadjah Mada University
Collaborators
Indonesia-MoH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related
Keywords
snakehead fish cookies, intrauterine fetal growth, low birth weight, randomized controlled trial, protein supplementation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Snakehead fish cookies
Arm Type
Experimental
Arm Description
Subjects who were given intervention of snakehead fish cookies during the study period
Arm Title
Standard cookies
Arm Type
Placebo Comparator
Arm Description
Subjects who were in control group and received standard cookies
Intervention Type
Dietary Supplement
Intervention Name(s)
cookies
Intervention Description
Either snakehead fish cookies or standard cookies were given to subjects 75g per day.
Primary Outcome Measure Information:
Title
Estimated fetal weight (EFW)
Description
We measured EFW monthly using 2D ultrasonography (USG) for each subjects
Time Frame
change from baseline EFW after 1 month
Title
Biparietal diameter (BPD)
Description
We measured BPD monthly using 2D ultrasonography (USG) for each subjects
Time Frame
change from baseline BPD after 1 month
Title
Abdominal circumference (AC)
Description
We measured AC monthly using 2D ultrasonography (USG) for each subjects
Time Frame
change from baseline AC after 1 month
Title
Femur length (FL)
Description
We measured FL monthly using 2D ultrasonography (USG) for each subjects
Time Frame
change from baseline FL after 1 month
Title
Birth weight
Description
Birth weight of the baby
Time Frame
immediately after the baby is born
Title
Birth length
Description
Birth length of the baby
Time Frame
immediately after the baby is born

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugenius P Ganap, PhD
Organizational Affiliation
Gadjah Mada University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Public Health Center (Puskesmas) in the area of Sleman District
City
Sleman
State/Province
Yogyakarta
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This research was supported by Ministry of Health of Indonesia, and all data collected in this study were subject to Indonesian Ministry of Health rights.

Learn more about this trial

Protein Supplementation of Snakehead Fish Cookies on Pregnant Women

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