跳至主要内容
临床试验/CTRI/2021/06/034487
CTRI/2021/06/034487已完成不适用

Incidence of neural tube defect and its detection on antenatal ultrasonography in an eastern Indian state: A population based cross sectional study.

Indian Council of Medical Research ICMR1 个研究点 分布在 1 个国家目标入组 153,948 人开始时间: 2021年4月7日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
153,948
试验地点
1
主要终点
We will get to know the incidence of neural tube defect of Odisha.

研究概览

简要总结

Background:

Neural tube defect creates a burden on the family as well as the society.  Managing a child with neural tube defect is difficult.  The disability is preventable if proper antenatal Care is provided.  The incidence of neural tube defect in Odisha is not known.  The Government of India is providing antenatal care through Pradhan Mantri Surakshit Matrutya Abhiyan (PMSMA) which includes ultrasonogram during second and third trimester of pregnancy. The ultrasonogram can diagnose the problem antenataly. Many patients of neural tube defect present in the neonatal period where the parents were completely unaware of the condition although ultrasound has been done during the antenatal period. The mothers in reproductive age group are also not aware of folic acid and zinc supplementation during antenatal period.

Novelty:

It will be a first of kind study on estimation incidence of NTD in Odisha and it will also evaluate the functioning of the PMSMA programme in detection of NTD. This will be the first study from India on neural tube defect covering an entire state.

Objective:

The study will attempt to detect the incidence of neural tube defect in Odisha as well as will attempt to determine the effectiveness of the antenatal care provided specifically to prevent and diagnose the defect.

Methods:

Data collection regarding neural tube defect will be done by door to door survey of sample population by showing pictures and albums of different types of neural tube defect.  Data will also be collected to analyze the results of ultrasound examination during antenatal period through PMSMA specifically for diagnosis of neural tube defect. Data will be analyzed.

Expected Outcome:

The study will determine the incidence of the neural tube defect and the effectiveness of diagnosis of the defect in antenatal period.  It will create an awareness regarding the antenatal diagnosis of the defect among the service providers.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Women in the reproductive age group and who had a history of pregnancy.

排除标准

  • Women who are never pregnant.

结局指标

主要结局

We will get to know the incidence of neural tube defect of Odisha.

时间窗: a.preparatory phase (Recruitment, plannining and Training): 2 months | b.data collection: 12 months | c.analysis & report writing: 3 months

次要结局

  • We will also get to know the effectiveness of PMSMA in preventing and detecting neural tube defects.(a. preparatory phase (Recruitment, plannining and Training): 2 months)

研究者

发起方
Indian Council of Medical Research ICMR
申办方类型
Government funding agency

研究点 (1)

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