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

NCT03932851 | Unknown

• 1 other identifier: KY2018-012
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

• Maternal and infant block failure rate in newborns

  Maternal and infant block failure rate in newborns

  up to 28 weeks

Secondary Outcomes (3)

• 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

Study Arms (2)

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.

Other: IVF-ET

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).

Other: IVF-ET

Interventions

IVF-ET OTHER

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

HBsAg(+) pregnant woman; HBsAg(-) pregnant woman

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: All enrolled subjects are pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Ditan Hospital: lead

Study Sites (1)

Pregnant women

Beijing, Beijing Municipality, 100015, China

RECRUITING

Central Study Contacts

Wei Yi, doctor

CONTACT

+86-13683687062; yiwei1215@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Obstetrics and Gynecology

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: May 1, 2019
• Study Start: August 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: May 1, 2019

Record last verified: 2019-04

Locations

CN (1)