Respiratory Viral InfectionsAPONCT07257952
APOs Associated With Respiratory Viral Infections Before and During Early Pregnancy
An observational study of Respiratory Viral Infections and Adverse Pregnancy Outcomes, run by Shanghai General Hospital, China.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Respiratory Viral Infections, Adverse Pregnancy Outcomes
- How many people
- 1,440 participants
- Where
- No sites listed yet
- Study dates
- 5 Jul 2026to 30 Nov 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women who are planning to conceive or pregnant women.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Observational Study on the Risk of Adverse Maternal and Infant Outcomes 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.
- Keywords
- Adverse pregnancy outcome, Preterm birth, Gestational diabetes mullitus, Respiratory Viral Infection
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Respiratory viral infections cohort | Women with respiratory viral infections during 6 months before pregnancy or early pregnancy | |
| Control cohort | Women without respiratory viral infections during 6 months before pregnancy or early pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of gestational diabetes mallitus
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.
Measured: 28 weeks of gestation
Secondary outcomes (1)
incidence of preterm birth
incidence of any births that occur before 37 completed weeks of gestation
Measured: 37 gestational weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start5 Jul 2026 (estimated)
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Respiratory Viral InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai General Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei Kang, Shanghai General Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257952
- Sponsor's protocol ID
- 2025-K434
- Acronym
- APO
- Status last verified
- Apr 2026
- First submitted
- 20 Nov 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD can be requested by sending an email to the corresponding author.
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 2020 Sep 21.
PubMed 32958663Gonzalez-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.
PubMed 40780523Oseghale 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 Aug.
PubMed 35930608Celik 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.
PubMed 38057579Wang 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.
PubMed 38783821Wang 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 respiratory syncytial virus in preterm infants and young children in 2019: a systematic review and meta-analysis of aggregated and individual participant data. Lancet. 2024 Mar 30;403(10433):1241-1253. doi: 10.1016/S0140-6736(24)00138-7. Epub 2024 Feb 14.
PubMed 38367641Kittikraisak 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 Cohort Study. J Infect Dis. 2025 Oct 15;232(4):e651-e655. doi: 10.1093/infdis/jiaf165.
PubMed 40176473Garcia-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 Obstet Hum Reprod. 2026 Jan;55(1):103058. doi: 10.1016/j.jogoh.2025.103058. Epub 2025 Oct 23.
PubMed 41139067Engjom HM, Ramakrishnan R, Vousden N, Bunch K, Morris E, Simpson N, Gale C, O'Brien P, Quigley M, Brocklehurst P, Kurinczuk JJ, Knight M. Perinatal outcomes after admission with COVID-19 in pregnancy: a UK national cohort study. Nat Commun. 2024 Apr 15;15(1):3234. doi: 10.1038/s41467-024-47181-z.
PubMed 38622110Zare F, Karimi A, Daliri S. Complications in Pregnant Women and Newborns Before and During the COVID-19 Pandemic. Iran J Nurs Midwifery Res. 2024 Jan 9;29(1):91-97. doi: 10.4103/ijnmr.ijnmr_252_22. eCollection 2024 Jan-Feb.
PubMed 38333333Sun Y, Luo X, Chen N, Xie L, Hu S, Zhou M, Wang L, Wang L, Li X, Yang Z, Yi P, Xu J. Impact of maternal COVID-19 infection on offspring immunity and maternal-fetal outcomes at different pregnancy stages: a cohort study. BMC Pregnancy Childbirth. 2025 Feb 28;25(1):219. doi: 10.1186/s12884-025-07323-7.
PubMed 40022096Wang Y, Guo Z, Ye B, Liu L, Mao X, Luo Y, Gao S, He G, Bian S. Association of SARS-CoV-2 Infection during Early Weeks of Gestation with Situs Inversus. N Engl J Med. 2023 Nov 2;389(18):1722-1724. doi: 10.1056/NEJMc2309215. No abstract available.
PubMed 37913512Conde-Agudelo A, Romero R. SARS-CoV-2 infection during pregnancy and risk of preeclampsia: a systematic review and meta-analysis. Am J Obstet Gynecol. 2022 Jan;226(1):68-89.e3. doi: 10.1016/j.ajog.2021.07.009. Epub 2021 Jul 21.
PubMed 34302772Camps J, Iftimie S, Jimenez-Franco A, Castro A, Joven J. Metabolic Reprogramming in Respiratory Viral Infections: A Focus on SARS-CoV-2, Influenza, and Respiratory Syncytial Virus. Biomolecules. 2025 Jul 16;15(7):1027. doi: 10.3390/biom15071027.
PubMed 40723899Darweesh M, Mohammadi S, Rahmati M, Al-Hamadani M, Al-Harrasi A. Metabolic reprogramming in viral infections: the interplay of glucose metabolism and immune responses. Front Immunol. 2025 May 16;16:1578202. doi: 10.3389/fimmu.2025.1578202. eCollection 2025.
PubMed 40453076