APOs Associated With Respiratory Viral Infections Before and During Early Pregnancy

NCT ID: NCT07257952

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1440 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-05
• Study Completion Date: 2027-11-30

Brief Summary

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.

Conditions

Respiratory Viral Infections; Adverse Pregnancy Outcomes

Study Design

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

Study Groups

Respiratory viral infections cohort

Women with respiratory viral infections during 6 months before pregnancy or early pregnancy

No interventions assigned to this group

Control cohort

Women without respiratory viral infections during 6 months before pregnancy or early pregnancy

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai General Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Mei Kang

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mei Kang, MPH

Role: CONTACT

mei.kang@shgh.cn

+8618501709576

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Other Identifiers

2025-K434

Identifier Type: -

Identifier Source: org_study_id