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临床试验/NCT03932851
NCT03932851Unknown不适用

Clinical Study on the Effect of IVF-ET on Mother-to-child Transmission of Hepatitis B Virus

Beijing Ditan Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2018年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
400
试验地点
1
主要终点
Maternal and infant block failure rate in newborns

研究概览

简要总结

This study is intended to retrospectively collect HBV-infected pregnant women and non-HBV-infected pregnant women who have been born in IVF in the investigators' hospital, collect pregnant women's data during pregnancy, newborn birth data, and hepatitis B virus in July after birth of newborns born to HBV-infected pregnant women. Infection, explore the impact of HBV infection on IVF outcomes and whether IVF operations increase the risk of mother-to-child transmission of HBV.

详细描述

This study is a retrospective study that only retrospectively collects a variety of patient data and does not perform any treatment or examination on the patient. The research design is as follows: 1. All patients with HBV-infected pregnant women and non-HBV-infected pregnant women who had undergone IVF operation were retrospectively collected from the investigators' hospital HIS system. 2.Collecting pregnant women's data from the HIS system (including age, maternal history, liver function during pregnancy, HBV DNA in early pregnancy and before delivery, complication and complications during pregnancy, antiviral use before and during pregnancy, father HBV infection Status), neonatal birth data (including body length, weight, Apgar score, feeding status, hepatitis B vaccination, hepatitis B immunoglobulin use, HBsAg at birth and 7 months after birth, HBV DNA). 3. Statistical analysis: (1) Compare the body length, body weight, Apgar score of newborns born to pregnant women with HBV infection and non-HBV infection, and understand the effect of HBV infection on IVF outcomes. (2) Newborns born to HBV-infected pregnant women were divided into HBV DNA-negative group, low-viral group, and high-viral group according to HBV DNA status. The HBV infection status of these newborns was counted in July, and the different viral loads were tested. The impact on mother-to-child transmission of HBV. (3) When discussing whether IVF operation increases the rate of mother-to-child transmission of HBV, it is more scientific and persuasive to use HBV-infected pregnant women who have not been operated with IVF, but the incidence of twins in IVF is significantly higher than that of natural pregnancy. Further lead to premature birth, postpartum hemorrhage, cesarean section rate, etc., the weight and length of newborns are also affected, so it is difficult to match the appropriate population, so this study decided to HBV infection rate of different HBV DNA load IVF Compared with the literature, the corresponding viral load of HBV infection was compared with the rate of mother-to-child transmission of IVF pregnant women.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant women who have been IVF-operated
  • HBV-infected pregnant women need to be positive for HBsAg for more than half a year.

排除标准

  • Combined with pregnancy-induced hypertension, premature rupture of membranes, prenatal bleeding and other diseases;
  • history of amniocentesis during pregnancy;
  • combined with other viral infections: such as HCV, HIV, CMV.

结局指标

主要结局

Maternal and infant block failure rate in newborns

时间窗: up to 28 weeks

Maternal and infant block failure rate in newborns

次要结局

  • The length of the newborn and the incidence of various complications during pregnancy.(up to 28 weeks)
  • The weight of the newborn and the incidence of various complications during pregnancy.(up to 28 weeks)
  • The Apgar score of the newborn and the incidence of various complications during pregnancy.(up to 28 weeks)

研究者

发起方
Beijing Ditan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wei Yi

Director, Head of Obstetrics and Gynecology

Beijing Ditan Hospital

研究点 (1)

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