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

NCT ID: NCT03932851

Last Updated: 2019-05-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2019-05-01

Brief Summary

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.

Detailed Description

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.

Conditions

Pregnancy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

HBsAg(+) pregnant woman

Data from pregnant women during pregnancy (including age, maternal history, liver function during pregnancy, HBV DNA in early pregnancy and before delivery, comorbidities and complications during pregnancy, antiviral use before and during pregnancy, and HBV infection status in fathers) Newborn 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). The 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 of HBV mother-to-child transmission.

IVF-ET

Intervention Type: OTHER

HBV-infected pregnant women and non-HBV-infected pregnant women underwent IVF operation

HBsAg(-) pregnant woman

Data from pregnant women during pregnancy (including age, maternal history, liver function during pregnancy, HBV DNA in early pregnancy and before delivery, comorbidities and complications during pregnancy, antiviral use before and during pregnancy, and HBV infection status in fathers) Newborn 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).

IVF-ET

Intervention Type: OTHER

HBV-infected pregnant women and non-HBV-infected pregnant women underwent IVF operation

Interventions

IVF-ET

HBV-infected pregnant women and non-HBV-infected pregnant women underwent IVF operation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Ditan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wei Yi

Director, Head of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pregnant women

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wei Yi, doctor

Role: CONTACT

yiwei1215@163.com

+86-13683687062

Facility Contacts

Wei Yi, doctor

Role: primary

yiwei1215@163.com

+86-1383687062

Other Identifiers

KY2018-012

Identifier Type: -

Identifier Source: org_study_id