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NCT Number: NCT07257952

APOs Associated With Respiratory Viral Infections Before and During Early Pregnancy

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. incidence of gestational diabetes mallitus

    Time frame: 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 outcomes

  1. incidence of preterm birth

    Time frame: 37 gestational weeks

    incidence of any births that occur before 37 completed weeks of gestation

Study contacts

Contact information is provided by the study sponsor or research team.

Mei Kang, MPH

CONTACT

[email protected]

+8618501709576

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, China

Other

Registry information

Official study title

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

Acronym: APO

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 2, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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