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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Birth weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 25 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •suffering from anemia,
- •experiencing preeclampsia,
- •having multiple gestational, and
- •allergic to fish, eggs, and chocolate.
研究组 & 干预措施
Snakehead fish cookies
Subjects who were given intervention of snakehead fish cookies during the study period
干预措施: cookies (Dietary Supplement)
Standard cookies
Subjects who were in control group and received standard cookies
干预措施: cookies (Dietary Supplement)
结局指标
主要结局
Birth weight
时间窗: immediately after the baby is born
Birth weight of the baby
Femur length (FL)
时间窗: change from baseline FL after 1 month
We measured FL monthly using 2D ultrasonography (USG) for each subjects
Estimated fetal weight (EFW)
时间窗: change from baseline EFW after 1 month
We measured EFW monthly using 2D ultrasonography (USG) for each subjects
Abdominal circumference (AC)
时间窗: change from baseline AC after 1 month
We measured AC monthly using 2D ultrasonography (USG) for each subjects
Birth length
时间窗: immediately after the baby is born
Birth length of the baby
Biparietal diameter (BPD)
时间窗: change from baseline BPD after 1 month
We measured BPD monthly using 2D ultrasonography (USG) for each subjects
次要结局
未报告次要终点
研究者
Eugenius Phyowai Ganap
Principal Investigator
Gadjah Mada University