Protein Supplementation of Snakehead Fish Cookies on Pregnant Women

Study Overview
=================
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.

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

Conditions
-----------------
Pregnancy Related

Intervention / Treatment
-----------------
* Dietary Supplement: cookies


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Snakehead fish cookies<br>Subjects who were given intervention of snakehead fish cookies during the study period | Dietary Supplement: cookies<br>* Either snakehead fish cookies or standard cookies were given to subjects 75g per day.<br>|
| Placebo Comparator: Standard cookies<br>Subjects who were in control group and received standard cookies | Dietary Supplement: cookies<br>* Either snakehead fish cookies or standard cookies were given to subjects 75g per day.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
snakehead fish cookies, intrauterine fetal growth, low birth weight, randomized controlled trial, protein supplementation