COVID-19 in Pregnancy and Early Childhood (COPE): study protocol for a prospective, multicentre biobank, survey and database cohort study

Ylva Carlsson, Lina Bergman, Mehreen Zaigham, Karolina Linden, Ola Andersson, Malin Veje, Anna Sandström, Anna-Karin Wikström, Hanna Östling, Helena Fadl, Magnus Domellöf, Marie Blomberg, Sophia Brismar Wendel, Ulrika Åden, Verena Sengpiel, COPE study group, Anders Elfvin, Anna Hagman, Anna Sand, Anna Wessberg, Anna-Carin Wihlbäck, Elin Naurin, Emma Von Wowern, Fredrik Ahlsson, Gilda Dumitrescu, Gustaf Biasoletto, Jan-Åke Liljeqvist, Johan Berg, Johanna Berg, Kathrin Rothbarth, Kristina Pettersson, Linda Hjertberg, Linda Iorizzo, Magnus Lindh, Maria Jonsson, Maria Lindqvist, Maria Revelj, Maria Svenvik, Marie Vikström Bolin, Marie-Charlotte Nilsson, Matilda Friman Mathiasson, Merit Kullinger, Mirjana Janes-Nakic, Ove Karlsson, Pihla Kuusela, Sandra Holmström, Sofie Graner, Susanne Woxenius, Thomas Abrahamsson, Åsa Leijonhufvud, Åsa Pontén, Ylva Carlsson, Lina Bergman, Mehreen Zaigham, Karolina Linden, Ola Andersson, Malin Veje, Anna Sandström, Anna-Karin Wikström, Hanna Östling, Helena Fadl, Magnus Domellöf, Marie Blomberg, Sophia Brismar Wendel, Ulrika Åden, Verena Sengpiel, COPE study group, Anders Elfvin, Anna Hagman, Anna Sand, Anna Wessberg, Anna-Carin Wihlbäck, Elin Naurin, Emma Von Wowern, Fredrik Ahlsson, Gilda Dumitrescu, Gustaf Biasoletto, Jan-Åke Liljeqvist, Johan Berg, Johanna Berg, Kathrin Rothbarth, Kristina Pettersson, Linda Hjertberg, Linda Iorizzo, Magnus Lindh, Maria Jonsson, Maria Lindqvist, Maria Revelj, Maria Svenvik, Marie Vikström Bolin, Marie-Charlotte Nilsson, Matilda Friman Mathiasson, Merit Kullinger, Mirjana Janes-Nakic, Ove Karlsson, Pihla Kuusela, Sandra Holmström, Sofie Graner, Susanne Woxenius, Thomas Abrahamsson, Åsa Leijonhufvud, Åsa Pontén

Abstract

Introduction: There is limited knowledge on how the SARS-CoV-2 affects pregnancy outcomes. Studies investigating the impact of COVID-19 in early pregnancy are scarce and information on long-term follow-up is lacking.The purpose of this project is to study the impact of COVID-19 on pregnancy outcomes and long-term maternal and child health by: (1) establishing a database and biobank from pregnant women with COVID-19 and presumably non-infected women and their infants and (2) examining how women and their partners experience pregnancy, childbirth and early parenthood in the COVID-19 pandemic.

Methods and analysis: This is a national, multicentre, prospective cohort study involving 27 Swedish maternity units accounting for over 86 000 deliveries/year. Pregnant women are included when they: (1) test positive for SARS-CoV-2 (COVID-19 group) or (2) are non-infected and seek healthcare at one of their routine antenatal visits (screening group). Blood, as well as other biological samples, are collected at different time points during and after pregnancy. Child health up to 4 years of age and parent experience of pregnancy, delivery, early parenthood, healthcare and society in general will be examined using web-based questionnaires based on validated instruments. Short- and long-term health outcomes will be collected from Swedish health registers and the parents' experiences will be studied by performing qualitative interviews.

Ethics and dissemination: Confidentiality aspects such as data encryption and storage comply with the General Data Protection Regulation and with ethical committee requirements. This study has been granted national ethical approval by the Swedish Ethical Review Authority (dnr 2020-02189 and amendments 2020-02848, 2020-05016, 2020-06696 and 2021-00870) and national biobank approval by the Biobank Väst (dnr B2000526:970). Results from the project will be published in peer-reviewed journals.

Trial registration number: NCT04433364.

Keywords: COVID-19; epidemiology; neonatology; obstetrics.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1
Figure 1
(A) COVID-19 group: data and biospecimen collection overview. (B) Screening group: data and biospecimen collection overview. BSES, Breastfeeding Self-Efficacy Scale short form; CEQ, Childbirth Experience Questionnaire; COPE, COVID-19 in Pregnancy and Early Childhood; EPDS, Edinburgh Postnatal Depression Scale; EQ5D, EuroQol 5D; FTFQ, First Time Fathers Questionnaire; GSE, General Self-Efficacy scale; HADS, Hospital Anxiety and Depression Scale; SOC, Sense of Coherence Scale; SQ-PTSD, Screen Questionnaire-Post-Traumatic Stress Disorder; VAS, Visual Analogue Scale.

References

    1. Alfaraj SH, Al-Tawfiq JA, Memish ZA. Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infection during pregnancy: Report of two cases & review of the literature. J Microbiol Immunol Infect 2019;52:501–3. 10.1016/j.jmii.2018.04.005
    1. Liu Y, Chen H, Tang K, et al. . Withdrawn: clinical manifestations and outcome of SARS-CoV-2 infection during pregnancy. J Infect 2020;80. 10.1016/j.jinf.2020.02.028
    1. Zaigham M, Andersson O. Maternal and perinatal outcomes with COVID-19: a systematic review of 108 pregnancies. Acta Obstet Gynecol Scand 2020;99:823–9. 10.1111/aogs.13867
    1. Allotey J, Stallings E, Bonet M, et al. . Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis. BMJ 2020;370:m3320. 10.1136/bmj.m3320
    1. Knight M, Bunch K, Vousden N, et al. . Characteristics and outcomes of pregnant women admitted to hospital with confirmed SARS-CoV-2 infection in UK: national population based cohort study. BMJ 2020;369:m2107. 10.1136/bmj.m2107
    1. Ronnje L, Länsberg J-K, Vikhareva O, et al. . Complicated COVID-19 in pregnancy: a case report with severe liver and coagulation dysfunction promptly improved by delivery. BMC Pregnancy Childbirth 2020;20:511. 10.1186/s12884-020-03172-8
    1. Kolkova Z, Bjurström MF, Länsberg J-K, et al. . Obstetric and intensive-care strategies in a high-risk pregnancy with critical respiratory failure due to COVID-19: a case report. Case Rep Womens Health 2020;27:e00240. 10.1016/j.crwh.2020.e00240
    1. D'Souza R, Malhamé I, Teshler L, et al. . A critical review of the pathophysiology of thrombotic complications and clinical practice recommendations for thromboprophylaxis in pregnant patients with COVID-19. Acta Obstet Gynecol Scand 2020;99:1110–20. 10.1111/aogs.13962
    1. Ahlberg M, Neovius M, Saltvedt S, et al. . Association of SARS-CoV-2 test status and pregnancy outcomes. JAMA 2020;324:1782. 10.1001/jama.2020.19124
    1. Remaeus K, Savchenko J, Brismar Wendel S, et al. . Characteristics and short-term obstetric outcomes in a case series of 67 women test-positive for SARS-CoV-2 in Stockholm, Sweden. Acta Obstet Gynecol Scand 2020;99:1626–31. 10.1111/aogs.14006
    1. Salvatore CM, Han J-Y, Acker KP, et al. . Neonatal management and outcomes during the COVID-19 pandemic: an observation cohort study. Lancet Child Adolesc Health 2020;4:721–7. 10.1016/S2352-4642(20)30235-2
    1. Molloy EJ, Lavizzari A, Klingenberg C, et al. . Neonates in the COVID-19 pandemic. Pediatr Res 2021;89:1038–40. 10.1038/s41390-020-1096-y
    1. Vivanti AJ, Vauloup-Fellous C, Prevot S, et al. . Transplacental transmission of SARS-CoV-2 infection. Nat Commun 2020;11:3572. 10.1038/s41467-020-17436-6
    1. Zaigham M, Holmberg A, Karlberg ML, et al. . Intrauterine vertical SARS-CoV-2 infection: a case confirming transplacental transmission followed by divergence of the viral genome. BJOG 2021;128:1388–94. 10.1111/1471-0528.16682
    1. Fan C, Lei D, Fang C, et al. . Perinatal transmission of 2019 coronavirus Disease–Associated severe acute respiratory syndrome coronavirus 2: should we worry? Clin Infect Dis 2021;72:862–4. 10.1093/cid/ciaa226
    1. Zhu H, Wang L, Fang C, et al. . Clinical analysis of 10 neonates born to mothers with 2019-nCoV pneumonia. Transl Pediatr 2020;9:51–60. 10.21037/tp.2020.02.06
    1. Zeng L, Xia S, Yuan W, et al. . Neonatal early-onset infection with SARS-CoV-2 in 33 neonates born to mothers with COVID-19 in Wuhan, China. JAMA Pediatr 2020;174:722. 10.1001/jamapediatrics.2020.0878
    1. Norman M, Navér L, Söderling J, et al. . Association of maternal SARS-CoV-2 infection in pregnancy with neonatal outcomes. JAMA 2021;325:2076. 10.1001/jama.2021.5775
    1. Zhou Z, Kang H, Li S, et al. . Understanding the neurotropic characteristics of SARS-CoV-2: from neurological manifestations of COVID-19 to potential neurotropic mechanisms. J Neurol 2020;267:2179–84. 10.1007/s00415-020-09929-7
    1. Tsafaras GP, Ntontsi P, Xanthou G. Advantages and limitations of the neonatal immune system. Front Pediatr 2020;8:5. 10.3389/fped.2020.00005
    1. Al-Haddad BJS, Jacobsson B, Chabra S, et al. . Long-Term risk of neuropsychiatric disease after exposure to infection in utero. JAMA Psychiatry 2019;76:594–602. 10.1001/jamapsychiatry.2019.0029
    1. Naurin E, Markstedt E, Stolle D, et al. . Pregnant under the pressure of a pandemic: a large-scale longitudinal survey before and during the COVID-19 outbreak. Eur J Public Health 2021;31:7–13. 10.1093/eurpub/ckaa223
    1. Ceulemans M, Foulon V, Ngo E, et al. . Mental health status of pregnant and breastfeeding women during the COVID-19 pandemic-A multinational cross-sectional study. Acta Obstet Gynecol Scand 2021;100:1219–29. 10.1111/aogs.14092
    1. Bergman NJ, Ludwig RJ, Westrup B, et al. . Nurturescience versus neuroscience: a case for rethinking perinatal mother-infant behaviors and relationship. Birth Defects Res 2019;111:1110–27. 10.1002/bdr2.1529
    1. Furuta M, Sandall J, Bick D. Women's perceptions and experiences of severe maternal morbidity--a synthesis of qualitative studies using a meta-ethnographic approach. Midwifery 2014;30:158–69. 10.1016/j.midw.2013.09.001
    1. Furuta M, Sandall J, Bick D. A systematic review of the relationship between severe maternal morbidity and post-traumatic stress disorder. BMC Pregnancy Childbirth 2012;12:125. 10.1186/1471-2393-12-125
    1. Bradley R, Slade P. A review of mental health problems in fathers following the birth of a child. J Reprod Infant Psychol 2011;29:19–42. 10.1080/02646838.2010.513047
    1. midwives TSAo . The qualifications of registered midwives, 2018.
    1. (SBU) Sbfuamm . Rutinmässig ultraljudsundersökning under graviditet, 1998.
    1. Public Health Agency of Sweden . Statistik och analyser Om covid-19 inklusive vaccinationer: public health agency of Sweden, 2021. Available:
    1. Naurin E. Gothenburg research program on pregnancy and politics (PregDem) Gothenb urg, Sweden, 2020. Available:
    1. Elo S, Kyngäs H. The qualitative content analysis process. J Adv Nurs 2008;62:107–15. 10.1111/j.1365-2648.2007.04569.x
    1. Berglund S, Westrup B, Domellöf M. Iron supplements reduce the risk of iron deficiency anemia in marginally low birth weight infants. Pediatrics 2010;126:e874–83. 10.1542/peds.2009-3624
    1. Andersson O, Domellöf M, Andersson D, et al. . Effects of delayed cord clamping on neurodevelopment and infection at four months of age: a randomised trial. Acta Paediatr 2013;102:525–31. 10.1111/apa.12168
    1. Andersson O, Lindquist B, Lindgren M, et al. . Effect of delayed cord clamping on neurodevelopment at 4 years of age: a randomized clinical trial. JAMA Pediatr 2015;169:631–8. 10.1001/jamapediatrics.2015.0358
    1. Andersson O, Domellöf M, Andersson D, et al. . Effect of delayed vs early umbilical cord clamping on iron status and neurodevelopment at age 12 months: a randomized clinical trial. JAMA Pediatr 2014;168:547–54. 10.1001/jamapediatrics.2013.4639
    1. Dahlberg KD, Nyström Pettersson M. Reflective Lifeworld research. Lund, Sweden: Studentlitteratur, 2008.
    1. Shah PS, Diambomba Y, Acharya G, et al. . Classification system and case definition for SARS-CoV-2 infection in pregnant women, fetuses, and neonates. Acta Obstet Gynecol Scand 2020;99:565–8. 10.1111/aogs.13870
    1. Usami S-I, Kitoh R, Moteki H, et al. . Etiology of single-sided deafness and asymmetrical hearing loss. Acta Otolaryngol 2017;137:S2–7. 10.1080/00016489.2017.1300321
    1. Prefumo F, Fichera A, Fratelli N, et al. . Fetal anemia: diagnosis and management. Best Pract Res Clin Obstet Gynaecol 2019;58:2–14. 10.1016/j.bpobgyn.2019.01.001
    1. Stephansson O, Petersson K, Björk C, et al. . The Swedish Pregnancy Register - for quality of care improvement and research. Acta Obstet Gynecol Scand 2018;97:466–76. 10.1111/aogs.13266
    1. Norman M, Källén K, Wahlström E, et al. . The Swedish Neonatal Quality Register - contents, completeness and validity. Acta Paediatr 2019;108:1411–8. 10.1111/apa.14823
    1. Ludvigsson JF, Andersson E, Ekbom A, et al. . External review and validation of the Swedish national inpatient register. BMC Public Health 2011;11:450. 10.1186/1471-2458-11-450
    1. Wettermark B, Hammar N, Fored CM, et al. . The new Swedish Prescribed Drug Register--opportunities for pharmacoepidemiological research and experience from the first six months. Pharmacoepidemiol Drug Saf 2007;16:726–35. 10.1002/pds.1294

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