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Not yet recruitingNCT07257952APOUpdated Apr 23, 2026

APOs Associated With Respiratory Viral Infections Before and During Early Pregnancy

An observational study in Respiratory Viral Infections and Adverse Pregnancy Outcomes, sponsored by Shanghai General Hospital, China. Not yet recruiting. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Shanghai General Hospital, China · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,440
Ages
20 Years to 45 Years
Sex
Female
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Study 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.

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Conditions studied

  • Respiratory Viral Infections
  • Adverse Pregnancy Outcomes

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Keywords

  • Adverse pregnancy outcome
  • Preterm birth
  • Gestational diabetes mullitus
  • Respiratory Viral Infection
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In context

Premature Birth

2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.

This study's planned enrollment of 1,440 is above the median of 120 across 806 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Shanghai General Hospital, China is the lead sponsor of 8 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women who are planning to conceive or pregnant women.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Pregestational T1D or T2D;
  • Long-term use of or ;
  • Diseases that severely affect immune or metabolic function (e.g., , SLE, rheumatoid arthritis);
  • Severe mental illness or cognitive impairment;
  • Women whose electronic medical records lack GDM screening and delivery records.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,440 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 28 weeks of gestation

Secondary outcomes

  1. incidence of preterm birth

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

    Time frame: 37 gestational weeks

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Study locations

No study locations are listed for this record.

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References and documents

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 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. PubMed 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 Aug. PubMed 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. PubMed 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. PubMed 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 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 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 Cohort Study. J Infect Dis. 2025 Oct 15;232(4):e651-e655. doi: 10.1093/infdis/jiaf165. PubMed 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 Obstet Hum Reprod. 2026 Jan;55(1):103058. doi: 10.1016/j.jogoh.2025.103058. Epub 2025 Oct 23. PubMed 41139067 ↗
  • Engjom 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 38622110 ↗
  • Zare 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 38333333 ↗
  • Sun 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 40022096 ↗
  • Wang 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 37913512 ↗
  • Conde-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 34302772 ↗
  • Camps 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 40723899 ↗
  • Darweesh 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 ↗
  • Lee H, Yoon D, Kim JH, Noh Y, Joo EJ, Han JY, Choe YJ, Shin JY. Association of Influenza Vaccination During Pregnancy with Health Outcomes in Mothers and Children: A Population-Based Cohort Study. Clin Pharmacol Ther. 2025 May;117(5):1381-1392. doi: 10.1002/cpt.3565. Epub 2025 Jan 23. PubMed 39854110 ↗
  • Trotta F, Da Cas R, Spila Alegiani S, Gramegna M, Venegoni M, Zocchetti C, Traversa G. Evaluation of safety of A/H1N1 pandemic vaccination during pregnancy: cohort study. BMJ. 2014 May 29;348:g3361. doi: 10.1136/bmj.g3361. PubMed 24874845 ↗
  • Speake HA, Pereira G, Regan AK. Risk of adverse maternal and foetal outcomes associated with inactivated influenza vaccination in first trimester of pregnancy. Paediatr Perinat Epidemiol. 2021 Mar;35(2):196-205. doi: 10.1111/ppe.12715. Epub 2020 Nov 5. PubMed 33155331 ↗
  • Idowu MB, Dotters-Katz SK, Kuller JA, Grace MR, Gatta LA. Seasonal Influenza in Pregnancy. Obstet Gynecol Surv. 2025 Jul;80(7):432-442. doi: 10.1097/OGX.0000000000001406. PubMed 40598809 ↗
  • Wei X, Narasimhan H, Zhu B, Sun J. Host Recovery from Respiratory Viral Infection. Annu Rev Immunol. 2023 Apr 26;41:277-300. doi: 10.1146/annurev-immunol-101921-040450. Epub 2023 Jan 30. PubMed 36716750 ↗
  • Gandhi L, Maisnam D, Rathore D, Chauhan P, Bonagiri A, Venkataramana M. Respiratory illness virus infections with special emphasis on COVID-19. Eur J Med Res. 2022 Nov 8;27(1):236. doi: 10.1186/s40001-022-00874-x. PubMed 36348452 ↗
  • Chasekwa B, Munhanzi F, Madhuyu L, Mbewe G, Mabika V, Chidhanguro D, Kofi T, Munengiwa J, Mapfumo H, Musapa M, Shumba S, Hungwe E, Nhokwara M, Bushe N, Kufa R, Mazula P, Chikombingo M, Tengende A, Zanga A, Ziruma A, Bere T, Munyengwa S, Mudimbu C, Murwira Z, Mudzingwa S, Mpofu E, Mutasa B, Sauramba V, Masakadze E, Runodamoto T, Chiorera C, Mushininga A, Bourke CD, Robertson RC, Perussolo J, Donos N, Nyachowe C, Muchekeza M, Chikunya J, Smuk M, Mutasa K, Tavengwa NV, Langhaug LL, Ntozini R, Munjanja SP, Prendergast AJ. A Trial of Trimethoprim-Sulfamethoxazole in Pregnancy to Improve Birth Outcomes. N Engl J Med. 2025 Jun 5;392(21):2125-2134. doi: 10.1056/NEJMoa2408114. PubMed 40466066 ↗
  • Crump C, Sundquist J, Sundquist K. Adverse Pregnancy Outcomes and Long-Term Mortality in Women. JAMA Intern Med. 2024 Jun 1;184(6):631-640. doi: 10.1001/jamainternmed.2024.0276. PubMed 38619848 ↗
  • Chen H, Li R, Liu S, Zhao S, Guo T, Tian S, Zhong J, Tang Z, Ge Z, Xia J, Geng T, Pan X, Pan A, Qian F, Liu G. Life's Essential 8 and cardiovascular disease in women with a history of adverse pregnancy outcomes. Eur J Prev Cardiol. 2025 Aug 5;32(10):833-842. doi: 10.1093/eurjpc/zwaf021. PubMed 39887026 ↗

Individual participant data

Plan to share: No — IPD can be requested by sending an email to the corresponding author.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07257952
Lead sponsor
Shanghai General Hospital, China
Responsible party
Mei Kang (Associate Professor, Shanghai General Hospital, China) — Principal investigator
First posted
Dec 2, 2025
Start date
Jul 5, 2026 (estimated)
Primary completion
Jul 30, 2028 (estimated)
Completion
Nov 30, 2028 (estimated)
Last update
Apr 23, 2026

Study contacts

Mei Kang, MPH
Contact
mei.kang@shgh.cn
+8618501709576

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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