跳至主要内容
临床试验/CTRI/2021/11/038318
CTRI/2021/11/038318尚未招募不适用

Placental changes in relation to SARS-Cov2 infection in pregnancy

MOSC Medical College1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2021年12月13日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
118
试验地点
1
主要终点
presence of maternal fetal vascular malperfusion in the placenta

研究概览

简要总结

With the COVID-19 pandemic at hand and with morepregnant women being infected with the SARS CoV2 virus, the potential ofvertical transmission is still debatable. We propose to conduct a study to analyse the pathological changes in theplacenta as a result of infection during pregnancy in comparison to Covid Negative mothers. We also aim to develop a profile of changes inthe placenta when affected by the disease. We will be conducting aretrospective study and collecting data from the COVID positive mothers that havedelivered at our institute from October 2020. All cases ofSARS CoV2 infection will be analysed over the period of one year and casessatisfying the selection criteria will have their pathological findingscompared with findings in normal placentas. We have estimated a sample size of59 in a group using data from a previous study on the prevalence ofchorangiosis in COVID positive placentas. At the end of the study, we hope toascertain the changes in the placenta due to COVID 19 infection which in turn couldhelp in the obstetric management of these patients.

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 mothers who were found to be Covid positive anytime during pregnancy
  • Mothers consenting to send their placenta for histopathological examination.

排除标准

  • History of other viral infections during pregnancy
  • Mothers diagnosed with preeclampsia or gestational hypertension or IUGR before the COVID infection
  • Those with pregestational diabetes, chronic hypertension and a history of thrombophilia.

结局指标

主要结局

presence of maternal fetal vascular malperfusion in the placenta

时间窗: at delivery

次要结局

  • maternal complications(21 days of infection)
  • Neonatal complications(7 days of age)

研究者

申办方类型
Private medical college

研究点 (1)

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