跳至主要内容
临床试验/CTRI/2022/09/045547
CTRI/2022/09/045547尚未招募不适用

A study to evaluate the effectiveness of family focused experiential learning intervention on micronutrients, maternal and infant outcomes among rural antenatal women at Thiruvallur district, Tamil Nadu.

Pratheesha1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2022年1月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
140
试验地点
1
主要终点
the level of hemoglobin, calcium, and vitamin D among rural antenatal women.

研究概览

简要总结

This study is a randomized control trial. This study is evaluating the effectiveness of family-focused experiential learning intervention for 7 months and 18 months of follow-up in 140 (70 in the intervention group and 70 in the control group) rural antenatal women in Thiruvallur district, Tamil Nadu, India. The primary outcome measures will be hemoglobin, calcium, and vitamin D status among rural antenatal women at enrollment (12 – 24 weeks of gestation), 37 weeks of gestation, and 6 months after delivery. The maternal secondary outcome measures will be knowledge, practice assessment, dietary pattern at enrollment (12 – 24 weeks of gestation), 37 weeks of gestation, and 6 months after delivery.  Gestational weight gain, gestational age at birth, mode of delivery, Apgar score, birth weight of the newborn, and maternal and fetus/newborn complications during antenatal, intranatal, and postpartum phase will be recorded after delivery. The infant’s secondary outcome measures will be Cognitive, motor, socio-emotional, language, and also infant length-for-age, weight-for-age, and weight-for-length at 6 months and 12 months of the infant.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • This study includes Rural Antenatal Women who are:
  • Above 18 to 35 years and from 12 weeks to 28 weeks of gestation
  • Rural antenatal women with Mild anemia-10-10.9gm/dl and Moderate anemia-7.1-10gm/dl (as per ICMR)
  • Who can understand Tamil and English
  • Those who are coming for a regular antenatal check-up .

排除标准

  • This study excludes rural antenatal women who are:
  • with co-morbidities like (kidney and liver disease)
  • Diagnosed psychiatric illness.
  • Severe Anemia.

结局指标

主要结局

the level of hemoglobin, calcium, and vitamin D among rural antenatal women.

时间窗: 6 months

次要结局

  • INFANT OUTCOMES:(infant growth and development (Cognitive, motor, socio-emotional, language, and adaptive behavior) and also infants’ length-for-age, weight-for-age, and weight-for-length.)
  • MATERNAL OUTCOMES : Knowledge and practice assessment, Dietary pattern, Gestational weight gain, gestational age at birth, mode of delivery, Apgar score, birth weight of new-born, maternal and fetus/new-born complications during antenatal, intranatal, and postpartum phase.

研究者

发起方
Pratheesha
申办方类型
Other [self]

研究点 (1)

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