APOs Associated With Respiratory Viral Infections Before and During Early Pregnancy

NCT07257952 | Not Yet Recruiting

• 1 other identifier: 2025-K434
• Study Type: observational
• Target: 1,440
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Respiratory Viral Infections; Adverse Pregnancy Outcomes

Keywords

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

Outcome Measures

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.

  28 weeks of gestation

Secondary Outcomes (1)

• incidence of preterm birth

  37 gestational weeks

Study Arms (2)

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

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: Women who are planning to conceive or pregnant women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women who are planning to conceive or pregnant women.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai General Hospital, China: lead

Related Publications (24)

• 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.

  PMID: 32958663 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 35930608 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 38367641 BACKGROUND

• 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.

  PMID: 40176473 BACKGROUND

• 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.

  PMID: 41139067 BACKGROUND

• 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.

  PMID: 38622110 BACKGROUND

• 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.

  PMID: 38333333 BACKGROUND

• 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.

  PMID: 40022096 BACKGROUND

• 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.

  PMID: 37913512 BACKGROUND

• 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.

  PMID: 34302772 BACKGROUND

• 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.

  PMID: 40723899 BACKGROUND

• 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.

  PMID: 40453076 BACKGROUND

• 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.

  PMID: 39854110 BACKGROUND

• 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.

  PMID: 24874845 BACKGROUND

• 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.

  PMID: 33155331 BACKGROUND

• 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.

  PMID: 40598809 BACKGROUND

• 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.

  PMID: 36716750 BACKGROUND

• 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.

  PMID: 36348452 BACKGROUND

• 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.

  PMID: 40466066 BACKGROUND

• 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.

  PMID: 38619848 BACKGROUND

• 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.

  PMID: 39887026 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Mei Kang, MPH

CONTACT

+8618501709576; mei.kang@shgh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 2, 2025
• Study Start (Estimated): July 5, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share