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临床试验/CTRI/2024/07/070180
CTRI/2024/07/070180尚未招募不适用

Prevalence Of Congenital Fetal Anomalies Detected On Third Trimester Ultrasound And At Birth - A Cross Sectional Study

Mahasweta Das1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年7月22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
20
试验地点
1
主要终点
To find out the prevalence of evolving fetal congenital anomalies detected on third

研究概览

简要总结

Introduction

Congenital anomalies are a major public health problem. As per the World Health Organization (WHO) congenital anomalies are defined as structural or functional anomalies,including metabolic disorders, present at the time of birth.Congenital anomalies occur during intrauterine life which can be detected prenatally, at birth or in later stages of life. Congenital anomalies can be subdivided into- minor and major anomalies. Minor anomalies are structural abnormality present at birth whereas, major congenital anomalies are severe enough to reduce life expectancy or may lead to difficulty in survival or result in still birth/infant death.(2) Congenital anomalies have been a major cause of neonatal and infant morbidity and mortality.As per World Health Organization, an estimate of 2,40,000 newborns die worldwide within 4 weeks of life every year due to congenital disorders.According to findings from different reviewed literature, the prevalence of congenital anomalies vary from country to country. Its is reported as 3% in the United States, 2.5% in Egypt, 2.5% in India, 2-3 % in United Kingdoms,1.07% in Japan and 4.3% in Taiwan.(7)

Need for the study

Fetal anomalies can be incidentally found at a third trimester ultrasound.This scenario can occur either because it was undiagnosed during the previous scans or the phenotypic expression of the abnormality becomes apparent only after 20 weeks, such as short limbs in the case of achondroplasia, dilated bowel in the case of bowel atresia or abnormal shape of the head in the case of craniosynostosis or the abnormality develops only in the third trimester, such as ovarian cyst in response to maternal estrogenic stimulation or ventriculomegaly following fetal brain hemorrhage or maternal infection. In many setting, third trimester ultrasound is not done and these abnormalities can remain undetected till birth. Many a times even after ultrasound being done at all three trimesters, some congenital anomalies remain undetected until birth and presents for the first time at birth. The need for the study is to find out the prevalence of evolving congenital anomalies detected for the first time on third trimester ultrasound and at birth

Study protocol:

All pregnant women who are more than 28 weeks coming to KAHER’S Dr. Prabhakar Kore Hospital for third trimester ultrasound or those delivering babies at KAHER’S Dr. Prabhakar Kore Hospital will be included in the study. After obtaining the approval from the Ethical committee and a waiver of consent, subjects will be recruited according to the inclusion and exclusion criteria. The patients who satisfy the inclusion criteria and do not fall under the exclusion criteria will be recruited in the study.

Data collection procedure:

All the pregnant women who are more than 28 weeks coming to KAHER’S Dr. Prabhakar Kore Hospital for third trimester ultrasound and those delivering babies at KAHER’S Dr. Prabhakar Kore Hospital will be included in the study. After obtaining the approval from the Ethical committee and a waiver of consent, subjects will be recruited according to the inclusion and exclusion criteria. Screening of all the women > 28 weeks who come for antenatal check up to KAHER’S Dr. Prabhakar Kore Hospital and women coming to deliver at KAHER’S Dr. Prabhakar Kore Hospital will be done from the medical records. The women with congenital anomalies detected for the first time in a third trimester ultrasound and women delivering neonates with congenital anomalies detected for the first time at birth, their detailed relevant history and data will be collected from the medical records

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

  • All pregnant women with more than 28weeks period of gestation who come for third trimester growth scan to KAHER’S Dr. Prabhakar Kore Hospital.
  • Pregnancies resulting in live birth or still birth at KAHER’S Dr. Prabhakar Kore Hospital.

排除标准

  • Those with known structural/chromosomal abnormality detected on previous anomaly scan.

结局指标

主要结局

To find out the prevalence of evolving fetal congenital anomalies detected on third

时间窗: 28 weeks to 42 weeks

trimester ultrasound and at birth.

时间窗: 28 weeks to 42 weeks

次要结局

未报告次要终点

研究者

发起方
Mahasweta Das
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Mahasweta Das

Jawaharlal Nehru Medical College, Belagavi

研究点 (1)

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