APOs Associated With Respiratory Viral Infections Before and During Early Pregnancy

Official title

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

Overview

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.

Primary outcome measures

• incidence of gestational diabetes mallitus [Time frame: 28 weeks of gestation]

Secondary outcome measures (1)

• incidence of preterm birth [Time frame: 37 gestational weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Liong S, Oseghale O, To EE, Brassington K, Erlich JR, Luong R, Liong F, Brooks R, Martin C, O'Toole S, Vinh A, O'Neill LAJ, Bozinovski S, Vlahos R, Papagianis PC, O'Leary JJ, Brooks DA, Selemidis S. Influenza A virus causes maternal and fetal pathology via innate and adaptive vascular inflammation in mice. Proc Natl Acad Sci U S A. 2020 Oct 6;117(40):24964-24973. doi: 10.1073/pnas.2006905117. Epub PMID 32958663
• Gonzalez-Ricon RJ, Otero AM, Chalen I, Savas JN, Adetunji S, Antonson AM. Influenza A virus infection during pregnancy increases transfer of maternal bloodborne molecules to fetal tissues. Brain Behav Immun. 2025 Nov;130:106069. doi: 10.1016/j.bbi.2025.106069. Epub 2025 Aug 6. PMID 40780523
• Oseghale O, Liong S, Coward-Smith M, To EE, Erlich JR, Luong R, Liong F, Miles M, Norouzi S, Martin C, O'Toole S, Brooks RD, Bozinovski S, Vlahos R, O'Leary JJ, Brooks DA, Selemidis S. Influenza A virus elicits peri-vascular adipose tissue inflammation and vascular dysfunction of the aorta in pregnant mice. PLoS Pathog. 2022 Aug 5;18(8):e1010703. doi: 10.1371/journal.ppat.1010703. eCollection 2022 PMID 35930608
• Celik IH, Tanacan A, Canpolat FE. Neonatal outcomes of maternal prenatal coronavirus infection. Pediatr Res. 2024 Jan;95(2):445-455. doi: 10.1038/s41390-023-02950-2. Epub 2023 Dec 6. PMID 38057579
• Wang J, Liu W, Zhuang Y, Yang J, Zhao Y, Hong A, Du J, Kong H, Wang J, Jiang Y, Wang Y. Influenza A virus infection disrupts the function of syncytiotrophoblast cells and contributes to adverse pregnancy outcomes. J Med Virol. 2024 Jun;96(6):e29687. doi: 10.1002/jmv.29687. PMID 38783821
• Wang X, Li Y, Shi T, Bont LJ, Chu HY, Zar HJ, Wahi-Singh B, Ma Y, Cong B, Sharland E, Riley RD, Deng J, Figueras-Aloy J, Heikkinen T, Jones MH, Liese JG, Markic J, Mejias A, Nunes MC, Resch B, Satav A, Yeo KT, Simoes EAF, Nair H; Respiratory Virus Global Epidemiology Network; RESCEU investigators. Global disease burden of and risk factors for acute lower respiratory infections caused by respirator PMID 38367641
• Kittikraisak W, Mohanty S, Klungthong C, Macareo L, Rawangban B, Tomyabatra K, Srisantiroj N, Phadungkiatwatana P, Chotpitayasunondh T, Kanjanapattanakul W, Mott JA, Kim L, Dawood FS. Antenatal Respiratory Syncytial Virus and Human Metapneumovirus Illness Rates Among Pregnant Women in Thailand and the Association Between Antenatal Respiratory Syncytial Virus and Perinatal Outcomes: A Prospective C PMID 40176473
• Garcia-Aguilar P, Rolle V, Serrano B, Rodo C, Garcia-Ruiz I, Garcia-Manau P, Farras A, Illan L, Moreno E, Dalmau M, Roldan E, Sirvent E, Temprado J, Seminario N, Fernandez-Hidalgo N, Sulleiro E, Balcells J, Ferrer-Costa R, Maiz N, Carreras E, Suy A, Mendoza M. Effect of SARS-CoV-2 infection on perinatal outcomes by disease severity and trimester of pregnancy: A prospective cohort study. J Gynecol PMID 41139067

Identifiers

NCT: NCT07257952 · 2025-K434

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗