APOs Associated With Respiratory Viral Infections Before and During Early Pregnancy

Shanghai General Hospital, China

Status

Not yet enrolling

Conditions

Adverse Pregnancy Outcomes

Respiratory Viral Infections

Study type

Observational

Funder types

Other

Identifiers

NCT07257952

2025-K434

Details and patient eligibility

About

Adverse pregnancy outcomes (APOs) are a collection of conditions that have short-term and long-term effects of complications related to pregnancy and childbirth on pregnant women and their fetuses, including hypertensive disorders of pregnancy, gestational diabetes, preterm birth, large for gestational age, among others. Nearly 30% of all women experience an adverse pregnancy outcome during their reproductive years. Although, respiratory viral infections with epidemic and pandemic potential pose an omnipresent threat to public health, research focusing specifically on the maternal-infant population remains relatively scarce.

Studies conducted in USA found that among pregnant women infected with influenza, the proportion of those with gestational hypertension or diabetes was higher than in pregnant women without influenza infection (13.9% vs. 11.1%).

Research on the impact of respiratory viral infections on perinatal outcomes in China is limited, and we aim to establish of a large-scale, retroprospective maternal-child cohorts. This cohort study will systematically collect longitudinal data (e.g., detailed clinical history, timing of infection/vaccination, complication of pregnancy, and APOs) to assess the risk of respiratory viral infections to APOs, as well as facilitate multidisciplinary research.

Enrollment

1,440 estimated patients

Sex

Female

Ages

20 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Female;
Age 20 to 45 years old;
Physician-diagnosed acute respiratory viral infection occurring within 6 months before pregnancy and/or at <24 weeks of gestation.

Exclusion criteria

Pregestational T1D or T2D;
Long-term use of immunosuppressants or glucocorticoids;
Diseases that severely affect immune or metabolic function (e.g., HIV, SLE, rheumatoid arthritis);
Severe mental illness or cognitive impairment;
Women whose electronic medical records lack GDM screening and delivery records.