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临床试验/CTRI/2024/04/064955
CTRI/2024/04/064955
尚未招募
不适用

Adverse perinatal outcomes in pregnancies with small for gestational age fetuses as compared to growth restricted fetuses as per the Delphi consensus and appropriately grown fetuses

未提供1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2024年4月10日最近更新:

概览

阶段
不适用
状态
尚未招募
入组人数
280
试验地点
1
主要终点
Composite adverse perinatal outcome will be compared among the two groups as compared to the control group and that with respect to each other

概览

简要总结

To determine adverse perinatal outcomes in pregnancies with small for gestational age fetuses as compared to growth

restricted fetuses as per the Delphi consensus and

appropriately grown fetuses. This is to understand the necessity of diagnosing as above as per the outcomes it states.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • Pregnant woman with correct dates as per first trimester ultrasound More than 28 weeks of gestation Willing to be a part of the study and delivering at AIIMS New Delhi.

排除标准

  • Presence of a fetal chromosomal or structural abnormality Multiple pregnancy Refusing consent to be a part of the study Not willing to follow up or deliver at AIIMS New Delhi.

结局指标

主要结局

Composite adverse perinatal outcome will be compared among the two groups as compared to the control group and that with respect to each other

时间窗: At the time of recruitment | At the time of ultrasound for growth parameters | At the time of delivery | Post delivery

The Composite adverse perinatal outcome will include

时间窗: At the time of recruitment | At the time of ultrasound for growth parameters | At the time of delivery | Post delivery

Perinatal demise stillbirth immediate neonatal demise or death before neonatal intensive

时间窗: At the time of recruitment | At the time of ultrasound for growth parameters | At the time of delivery | Post delivery

care unit NICU discharge

时间窗: At the time of recruitment | At the time of ultrasound for growth parameters | At the time of delivery | Post delivery

NICU admission

时间窗: At the time of recruitment | At the time of ultrasound for growth parameters | At the time of delivery | Post delivery

5 minute Apgar score of less than 7

时间窗: At the time of recruitment | At the time of ultrasound for growth parameters | At the time of delivery | Post delivery

Acute respiratory stress syndrome

时间窗: At the time of recruitment | At the time of ultrasound for growth parameters | At the time of delivery | Post delivery

Grade III to IV IVH and or PVL

时间窗: At the time of recruitment | At the time of ultrasound for growth parameters | At the time of delivery | Post delivery

Necrotising enterocolitis

时间窗: At the time of recruitment | At the time of ultrasound for growth parameters | At the time of delivery | Post delivery

Sepsis

时间窗: At the time of recruitment | At the time of ultrasound for growth parameters | At the time of delivery | Post delivery

Bronchopulmonary dysplasia

时间窗: At the time of recruitment | At the time of ultrasound for growth parameters | At the time of delivery | Post delivery

Anemia

时间窗: At the time of recruitment | At the time of ultrasound for growth parameters | At the time of delivery | Post delivery

Neonatal seizures

时间窗: At the time of recruitment | At the time of ultrasound for growth parameters | At the time of delivery | Post delivery

次要结局

  • Number of days of NICU stay(Number of days of hospital stay for baby)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr K Aparna Sharma

AIIMS New Delhi

研究点 (1)

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