APOs Associated With Respiratory Viral Infections Before and During Early Pregnancy

An Observational Study on the Risk of Adverse Maternal and Infant Outcomes Associated With Respiratory Viral Infections Before and During Early Pregnancy

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07257952

Acronym

APO

Enrollment

1440

Registered

2025-12-02

Start date

2026-07-05

Completion date

2028-11-30

Last updated

2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Pregnancy Outcomes, Respiratory Viral Infections

Keywords

Adverse pregnancy outcome, Preterm birth, Gestational diabetes mullitus, Respiratory Viral Infection

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 45 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
incidence of gestational diabetes mallitus	28 weeks of gestation	incidence of gestational diabetes mallitus according to International Association of Diabetes and Pregnancy Study Groups consensus if any one of the plasma glucose values is met or exceeded during a 75g oral glucose tolerance test (OGTT) at 20 to 28 gestational weeks.

Secondary

Measure	Time frame	Description
incidence of preterm birth	37 gestational weeks	incidence of any births that occur before 37 completed weeks of gestation

Contacts

CONTACTMei Kang, MPH

mei.kang@shgh.cn+8618501709576

Outcome results