Changing knowledge, attitudes and behaviours towards cytomegalovirus in pregnancy through film-based antenatal education: a feasibility randomised controlled trial of a digital educational intervention

Anna Calvert, Tushna Vandrevala, Robin Parsons, Victoria Barber, Alex Book, Gayle Book, David Carrington, Vanessa Greening, Paul Griffiths, Danielle Hake, Asma Khalil, Suzanne Luck, Amy Montague, Caroline Star, Irina Chis Ster, Sharon Wood, Paul T Heath, Christine E Jones, Anna Calvert, Tushna Vandrevala, Robin Parsons, Victoria Barber, Alex Book, Gayle Book, David Carrington, Vanessa Greening, Paul Griffiths, Danielle Hake, Asma Khalil, Suzanne Luck, Amy Montague, Caroline Star, Irina Chis Ster, Sharon Wood, Paul T Heath, Christine E Jones

Abstract

Background: Congenital cytomegalovirus (CMV) is the most common congenital infection globally, however information about CMV is not routinely included in antenatal education in the United Kingdom. This feasibility study aimed to gather the essential data needed to design and power a large randomised controlled trial (RCT) to investigate the efficacy of a digital intervention in reducing the risk of CMV acquisition in pregnancy. In order to do this, we carried out a single-centre RCT, which explored the knowledge, attitudes and risk reduction behaviours in women in the intervention and treatment as usual groups, pre- and post-intervention.

Methods: CMV seronegative women living with a child less than four years old, receiving antenatal care at a single UK tertiary centre, were randomised to the digital intervention or 'treatment as usual' groups. Participants completed questionnaires before the digital intervention and after and at 34 gestational weeks, and responses within groups and between groups were compared using tailored randomisation tests. CMV serology was tested in the first trimester and at the end of pregnancy.

Results: Of the 878 women screened, 865 samples were analysed with 43% (n = 372) being CMV seronegative and therefore eligible to take part in the RCT; of these, 103 (27.7%) women were enrolled and 87 (84%) of these completed the study. Most participants (n = 66; 64%) were unfamiliar with CMV at enrolment, however at 34 gestational weeks, women in the intervention group (n = 51) were more knowledgeable about CMV compared to the treatment as usual group (n = 52) and reported engaging in activities that may increase the risk of CMV transmission less frequently. The digital intervention was highly acceptable to pregnant women. Overall, four participants seroconverted over the course of the study: two from each study group.

Conclusions: A large multi-centre RCT investigating the efficacy of a CMV digital intervention is feasible in the United Kingdom; this study has generated essential data upon which to power such a study. This single-centre feasibility RCT demonstrates that a digital educational intervention is associated with increase in knowledge about CMV and can result in behaviour change which may reduce the risk of CMV acquisition in pregnancy.

Trial registration: Clinicaltrials.gov, NCT03511274 , Registered 27.04.18, http://www.Clinicaltrials.gov.

Keywords: Antenatal education; Congenital infection; Cytomegalovirus; Feasibility; Pregnancy.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
CONSORT flow diagram. CMV Cytomegalovirus; FMU Fetal Medicine Unit
Fig. 2
Fig. 2
Attitudes of pregnant women toward the severity of CMV and their susceptibility to CMV at baseline and 34 gestational weeks in the treatment as usual group and the intervention group. CMV Cytomegalovirus; INT Intervention group; TAU Treatment As Usual group; Intention to treat analyses between intervention and treatment as usual groups at baseline (pre-intervention) and at 34 weeks gestation (post-intervention) and within intervention and treatment as usual groups comparisons between baseline and 34 weeks gestation

References

    1. Griffiths PD, Baboonian C, Rutter D, Peckham C. Congenital and maternal cytomegalovirus infections in a London population. Br J Obstet Gynaecol. 1991;98(2):135–140. doi: 10.1111/j.1471-0528.1991.tb13358.x.
    1. Dollard SC, Grosse SD, Ross DS. New estimates of the prevalence of neurological and sensory sequelae and mortality associated with congenital cytomegalovirus infection. Rev Med Virol. 2007;17(5):355–363. doi: 10.1002/rmv.544.
    1. Mussi-Pinhata MM, Yamamoto AY, Moura Brito RM, de Lima Isaac M, de Carvalho e Oliveira PF, Boppana S, et al. Birth prevalence and natural history of congenital cytomegalovirus infection in a highly seroimmune population. Clin Infect Dis. 2009;49(4):522–8.
    1. Kenneson A, Cannon MJ. Review and meta-analysis of the epidemiology of congenital cytomegalovirus (CMV) infection. Rev Med Virol. 2007;17(4):253–276. doi: 10.1002/rmv.535.
    1. Staras SAS, Dollard SC, Radford KW, Flanders KW, Pass RF, Cannon MJ. Seroprevalence of Cytomegalovirus Infection in the United States, 1988–1994. Clin Infect Dis. 2006;43(9):1143–1151. doi: 10.1086/508173.
    1. Marsico C, Kimberlin DW. Congenital Cytomegalovirus infection: advances and challenges in diagnosis, prevention and treatment. Ital J Pediatr. 2017;43(1):38. doi: 10.1186/s13052-017-0358-8.
    1. Morton CC, Nance WE. Newborn Hearing Screening- A Silent Revolution. N Engl J Med. 2006;354(20):2151–2164. doi: 10.1056/NEJMra050700.
    1. Committee NS. Newborn screening for cytomegalovirus. 2017.
    1. Barber V, Calvert A, Vandrevala T, Star C, Khalil A, Griffiths P, Heath PT, Jones CE. Prevention of Acquisition of Cytomegalovirus Infection in Pregnancy Through Hygiene-based Behavioral Interventions: A Systematic Review and Gap Analysis. Pediatr Infect Dis J. 2020;39(10):949–954. doi: 10.1097/INF.0000000000002763.
    1. Vandrevala T, Barber V, Calvert A, Star C, Khalil A, Griffiths P, Heath PT, Jones CE. Understanding pregnant women’s readiness to engage in risk-reducing measures to prevent infections during pregnancy. J Health Psychol. 2019. 10.1177/1359105319884609
    1. Vandrevala T, Barber V, Mbire-Chigumba E, Calvert A, Star C, Khalil A, et al. Parenting a child with congenital cytomegalovirus infection: a qualitative study. BMJ Paediatr Open. 2020;4(1):e000844.
    1. Price SM, Bonilla E, Zador P, Levis DM, Kilgo CL, Cannon MJ. Educating women about congenital cytomegalovirus: assessment of health education materials through a web based survey. BMC Women’s Health. 2014;14(144). 10.1186/s12905-014-0144-3.
    1. R. K. Kessler Psychological Distress Scale (K10) [Available from: .
    1. Cox JL, Holden JM, Sagovsky R. Edinburgh Postnatal Depression Scale. Available from: .
    1. White IR, Horton NJ, Carpenter J, Pocock SJ. Strategy for intention to treat analysis in randomised trials with missing outcome data. Br Med J. 2011;342(d40). 10.1136/bmj.d40.
    1. Hess S. Randomization inference with Stata: A guide and software. Stand Genomic Sci. 2017;17(3):630–651.
    1. Kaiser J. An exact and a Monte Carlo proposal to the Fisher-Pitman permutation tests for paired replicates and for independent samples. Stand Genomic Sci. 2007;7(3):402–412.
    1. Harris T. Exact Wilcoxon signed-rank and Wilcoxon Mann-Whitney ranksum tests. Stand Genomic Sci. 2013;13(2):337–343.
    1. Chatfield M, Mander A. The Skillings-Mack test (Friedman test when there are missing data) Stand Genomic Sci. 2009;9(2):299–305.
    1. Vauloup-Fellous C, Picone O, Cordier AG, Parent-du-Chatelet I, Senat MV, Frydman R, et al. Does hygiene counseling have an impact on the rate of CMV primary infection during pregnancy? Results of a 3-year prospective study in a French hospital. J Clin Virol. 2009;46(Suppl 4):S49–53. doi: 10.1016/j.jcv.2009.09.003.
    1. Tookey PAAA, Peckham C. Cytomegalovirus prevalence in pregnant women: the influence of parity. Arch Dis Child. 1992;67:779–783. doi: 10.1136/adc.67.7_spec_no.779.
    1. Pembrey L, Raynor P, Griffiths P, Chaytor S, Wright J, Hall AJ. Seroprevalence of cytomegalovirus, Epstein Barr virus and varicella zoster virus among pregnant women in Bradford: a cohort study. PLoS ONE. 2013; 8(11):e81881.
    1. Revello MG, Tibaldi C, Masuelli G, Frisina V, Sacchi A, Furione M, et al. Prevention of Primary Cytomegalovirus Infection in Pregnancy. EBioMedicine. 2015;2(9):1205–1210. doi: 10.1016/j.ebiom.2015.08.003.
    1. Chatzakis C, Ville Y, Makrydimas G, Dinas K, Zavlanos A, Sotiriadis A. Timing of primary maternal cytomegalovirus infection and rates of vertical transmission and fetal consequences. Am J Obstet Gynecol. 2020; 223(6):870–83 e11.
    1. Lazzaro A, Vo ML, Zeltzer J, Rawlinson W, Nassar N, Daly K, et al. Knowledge of congenital cytomegalovirus (CMV) in pregnant women in Australia is low, and improved with education. Aust N Z J Obstet Gynaecol. 2019;59(6):843–849. doi: 10.1111/ajo.12978.
    1. Morioka I, Sonoyama A, Tairaku S, Ebina Y, Nagamata S, Morizane M, et al. Awareness of and knowledge about mother-to-child infections in Japanese pregnant women. Congenit Anom (Kyoto) 2014;54(1):35–40. doi: 10.1111/cga.12030.
    1. Lim SL, Tan WC, Tan LK. Awareness of and attitudes toward congenital cytomegalovirus infection among pregnant women in Singapore. Int J Gynaecol Obstet. 2012;117(3):268–272. doi: 10.1016/j.ijgo.2011.12.025.
    1. Jeon J, Victor M, Adler SP, Arwady A, Demmler G, Fowler K, et al. Knowledge and awareness of congenital cytomegalovirus among women. Infect Dis Obstet Gynecol. 2006;2006:80383. doi: 10.1155/IDOG/2006/80383.
    1. Cannon MJ. Congenital cytomegalovirus (CMV) epidemiology and awareness. J Clin Virol. 2009;46(Suppl 4):S6–10. doi: 10.1016/j.jcv.2009.09.002.
    1. Adler SP, Finney JW, Manganello AM, Best AM. Prevention of chid-to-mother transmission of cytomegalovirus by changing behaviors: a randomized controlled trial. Pediatr Infect Dis J. 1995;15(3):240–246. doi: 10.1097/00006454-199603000-00013.
    1. Adler SP, Finney JW, Manganello AM, Best AM. Prevention of child-to-mother transmission of cytomegalovirus among pregnant women. J Pediatr. 2004;145(4):485–491. doi: 10.1016/j.jpeds.2004.05.041.
    1. Hughes BL, Gans KM, Raker C, Hipolito ER, Rouse DJ. A Brief Prenatal Intervention of Behavioral Change to Reduce the Risk of Maternal Cytomegalovirus: A Randomized Controlled Trial. Obstet Gynecol. 2017;130(4):726–734. doi: 10.1097/AOG.0000000000002216.
    1. Thackeray R, Magnusson BM. Women’s attitudes toward practicing cytomegalovirus prevention behaviors. Prev Med Rep. 2016;4:517–24. 10.1016/j.pmedr.2016.09.008.
    1. Finney JW, Miller KM, Adler SP. Changing Protective And Risky Behaviors To Prevent Child-To-Parent Transmission of Cytomegalovirus. J Appl Behav Anal. 1993;26(4):471–472. doi: 10.1901/jaba.1993.26-471.

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