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Published in: BMC Pregnancy and Childbirth 1/2021

Open Access 01-12-2021 | Lactation | Research article

Perspectives of pregnant and breastfeeding women on longitudinal clinical studies that require non-invasive biospecimen collection – a qualitative study

Authors: Dominick J. Lemas, Lauren Wright, Elizabeth Flood-Grady, Magda Francois, Lynn Chen, Austen Hentschel, Xinsong Du, Chu J. Hsiao, Huan Chen, Josef Neu, Ryan P. Theis, Elizabeth Shenkman, Janice Krieger

Published in: BMC Pregnancy and Childbirth | Issue 1/2021

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Abstract

Background

Investigation of the microbiome during early life has stimulated an increasing number of cohort studies in pregnant and breastfeeding women that require non-invasive biospecimen collection. The objective of this study was to explore pregnant and breastfeeding women’s perspectives on longitudinal clinical studies that require non-invasive biospecimen collection and how they relate to study logistics and research participation.

Methods

We completed in-depth semi-structured interviews with 40 women who were either pregnant (n = 20) or breastfeeding (n = 20) to identify their understanding of longitudinal clinical research, the motivations and barriers to their participation in such research, and their preferences for providing non-invasive biospecimen samples.

Results

Perspectives on research participation were focused on breastfeeding and perinatal education. Participants cited direct benefits of research participation that included flexible childcare, lactation support, and incentives and compensation. Healthcare providers, physician offices, and social media were cited as credible sources and channels for recruitment. Participants viewed lengthy study visits and child protection as the primary barriers to research participation. The barriers to biospecimen collection were centered on stool sampling, inadequate instructions, and drop-off convenience.

Conclusion

Women in this study were interested in participating in clinical studies that require non-invasive biospecimen collection, and motivations to participate center on breastfeeding and the potential to make a scientific contribution that helps others. Effectively recruiting pregnant or breastfeeding participants for longitudinal microbiome studies requires protocols that account for participant interests and consideration for their time.
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Literature
1.
go back to reference Frew PM, Saint-Victor DS, Isaacs MB, et al. Recruitment and retention of pregnant women into clinical research trials: an overview of challenges, facilitators, and best practices. Clin Infect Dis 2014; 59:S400–S407. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4303058/pdf/ciu726.pdf. Frew PM, Saint-Victor DS, Isaacs MB, et al. Recruitment and retention of pregnant women into clinical research trials: an overview of challenges, facilitators, and best practices. Clin Infect Dis 2014; 59:S400–S407. Available at: https://​www.​ncbi.​nlm.​nih.​gov/​pmc/​articles/​PMC4303058/​pdf/​ciu726.​pdf.​
2.
go back to reference Yan J, Liu L, Zhu Y, Huang G, Wang PP. The association between breastfeeding and childhood obesity: a meta-analysis. BMC Public Health. 2014;14:1267.CrossRef Yan J, Liu L, Zhu Y, Huang G, Wang PP. The association between breastfeeding and childhood obesity: a meta-analysis. BMC Public Health. 2014;14:1267.CrossRef
4.
go back to reference Abrahamson M, Hooker E, Ajami NJ, Petrosino JF, Orwoll ES. Successful collection of stool samples for microbiome analyses from a large community-based population of elderly men. Contemp Clin Trials Commun. 2017;7:158–62.CrossRef Abrahamson M, Hooker E, Ajami NJ, Petrosino JF, Orwoll ES. Successful collection of stool samples for microbiome analyses from a large community-based population of elderly men. Contemp Clin Trials Commun. 2017;7:158–62.CrossRef
5.
go back to reference Flint HJ, Scott KP, Louis P, Duncan SH. The role of the gut microbiota in nutrition and health. Nat Rev Gastroenterol Hepatol. 2012;9:577–89.CrossRef Flint HJ, Scott KP, Louis P, Duncan SH. The role of the gut microbiota in nutrition and health. Nat Rev Gastroenterol Hepatol. 2012;9:577–89.CrossRef
6.
go back to reference Mueller NT, Bakacs E, Combellick J, Grigoryan Z, Dominguez-Bello MG. The infant microbiome development : mom matters. Trends Mol Med. 2015;21:1–9.CrossRef Mueller NT, Bakacs E, Combellick J, Grigoryan Z, Dominguez-Bello MG. The infant microbiome development : mom matters. Trends Mol Med. 2015;21:1–9.CrossRef
7.
go back to reference Dominguez-Bello MG, Costello EK, Contreras M, et al. Delivery mode shapes the acquisition and structure of the initial microbiota across multiple body habitats in newborns. Proc Natl Acad Sci. 2010;107:11971–5.CrossRef Dominguez-Bello MG, Costello EK, Contreras M, et al. Delivery mode shapes the acquisition and structure of the initial microbiota across multiple body habitats in newborns. Proc Natl Acad Sci. 2010;107:11971–5.CrossRef
8.
go back to reference Lemas DJ, Young BE, Baker PR, et al. Alterations in human milk leptin and insulin are associated with early changes in the infant intestinal microbiome. Am J Clin Nutr. 2016;103:1291–300.CrossRef Lemas DJ, Young BE, Baker PR, et al. Alterations in human milk leptin and insulin are associated with early changes in the infant intestinal microbiome. Am J Clin Nutr. 2016;103:1291–300.CrossRef
11.
go back to reference Aagaard K, Ma J, Antony KM, Ganu R, Petrosino J, Versalovic J. The placenta harbors a unique microbiome. Sci Transl Med 2014; 6:237ra65. Aagaard K, Ma J, Antony KM, Ganu R, Petrosino J, Versalovic J. The placenta harbors a unique microbiome. Sci Transl Med 2014; 6:237ra65.
12.
go back to reference Koren O, Goodrich JK, Cullender TC, et al. Host remodeling of the gut microbiome and metabolic changes during pregnancy. Cell. 2012;150:470–80.CrossRef Koren O, Goodrich JK, Cullender TC, et al. Host remodeling of the gut microbiome and metabolic changes during pregnancy. Cell. 2012;150:470–80.CrossRef
14.
go back to reference Lemas DJ, Yee S, Cacho N, et al. Exploring the contribution of maternal antibiotics and breastfeeding to development of the infant microbiome and pediatric obesity. Semin Fetal Neonatal Med. 2016;21:406–9.CrossRef Lemas DJ, Yee S, Cacho N, et al. Exploring the contribution of maternal antibiotics and breastfeeding to development of the infant microbiome and pediatric obesity. Semin Fetal Neonatal Med. 2016;21:406–9.CrossRef
15.
go back to reference Lecky DM, Nakiboneka-Ssenabulya D, Nichols T, et al. Informing future research for carriage of multiresistant gram-negative bacteria: problems with recruiting to an English stool sample community prevalence study. BMJ Open. 2017;7. Lecky DM, Nakiboneka-Ssenabulya D, Nichols T, et al. Informing future research for carriage of multiresistant gram-negative bacteria: problems with recruiting to an English stool sample community prevalence study. BMJ Open. 2017;7.
16.
go back to reference Smith JA. Chapter 2: semi-structured interviewing and qualitative analysis. Smith JA, Harre R, Van Langernhove L, eds. Rethinking Methods in Psychology: In; 1995. Smith JA. Chapter 2: semi-structured interviewing and qualitative analysis. Smith JA, Harre R, Van Langernhove L, eds. Rethinking Methods in Psychology: In; 1995.
18.
go back to reference Bazeley P. Qualitative data analysis: practical strategies; 2013. Bazeley P. Qualitative data analysis: practical strategies; 2013.
19.
go back to reference Kenyon S, Dixon-Woods M, Jackson CJ, Windridge K, Pitchforth E. Participating in a trial in a critical situation: a qualitative study in pregnancy. Qual Saf Heal Care. 2006;15:98–101.CrossRef Kenyon S, Dixon-Woods M, Jackson CJ, Windridge K, Pitchforth E. Participating in a trial in a critical situation: a qualitative study in pregnancy. Qual Saf Heal Care. 2006;15:98–101.CrossRef
21.
go back to reference Flood-Grady E, Paige SR, Karimipour N, Harris PA, Cottler LB, Krieger JL. A content analysis of Clinical and Translational Science Award (CTSA) strategies for communicating about clinical research participation online. J Clin Transl Sci 2017; 1:340–351. Available at: http://www.ncbi.nlm.nih.gov/pubmed/29707256. Flood-Grady E, Paige SR, Karimipour N, Harris PA, Cottler LB, Krieger JL. A content analysis of Clinical and Translational Science Award (CTSA) strategies for communicating about clinical research participation online. J Clin Transl Sci 2017; 1:340–351. Available at: http://​www.​ncbi.​nlm.​nih.​gov/​pubmed/​29707256.
22.
go back to reference Fallon V, Komninou S, Bennett KM, Halford JCG, Harrold JA. The emotional and practical experiences of formula-feeding mothers. Matern Child Nutr. 2017;13. Fallon V, Komninou S, Bennett KM, Halford JCG, Harrold JA. The emotional and practical experiences of formula-feeding mothers. Matern Child Nutr. 2017;13.
23.
go back to reference Smyth RMD, Jacoby A, Elbourne D. Deciding to join a perinatal randomised controlled trial: experiences and views of pregnant women enroled in the magpie trial. Midwifery. 2012;28:e538–45.CrossRef Smyth RMD, Jacoby A, Elbourne D. Deciding to join a perinatal randomised controlled trial: experiences and views of pregnant women enroled in the magpie trial. Midwifery. 2012;28:e538–45.CrossRef
25.
go back to reference Flood-Grady E, Clark VC, Bauer A, et al. Evaluating the efficacy of a registry linked to a consent to re-contact program and communication strategies for recruiting and enrolling participants into clinical trials. Contemp Clin Trials Commun. 2017;8:62–6.CrossRef Flood-Grady E, Clark VC, Bauer A, et al. Evaluating the efficacy of a registry linked to a consent to re-contact program and communication strategies for recruiting and enrolling participants into clinical trials. Contemp Clin Trials Commun. 2017;8:62–6.CrossRef
26.
go back to reference Sayakhot P, Carolan-Olah M. Internet use by pregnant women seeking pregnancy-related information: a systematic review. BMC Pregnancy Childbirth. 2016;16. Sayakhot P, Carolan-Olah M. Internet use by pregnant women seeking pregnancy-related information: a systematic review. BMC Pregnancy Childbirth. 2016;16.
27.
go back to reference Zimmerman TS, Aberle J, Krafchick J, Harvey A. Deconstructing the ‘mommy wars’: the battle over the best mom. J Fem Fam Ther. 2008;20:203–19.CrossRef Zimmerman TS, Aberle J, Krafchick J, Harvey A. Deconstructing the ‘mommy wars’: the battle over the best mom. J Fem Fam Ther. 2008;20:203–19.CrossRef
28.
go back to reference Chen LY, Flood-Grady E, Hentschel A, et al. A qualitative study of pregnant Women’s perspectives on antibiotic use for mom and child: implications for developing tailored health education interventions. Antibiotics 2020; 9:704. Available at: https://www.mdpi.com/2079-6382/9/10/704. Chen LY, Flood-Grady E, Hentschel A, et al. A qualitative study of pregnant Women’s perspectives on antibiotic use for mom and child: implications for developing tailored health education interventions. Antibiotics 2020; 9:704. Available at: https://​www.​mdpi.​com/​2079-6382/​9/​10/​704.​
Metadata
Title
Perspectives of pregnant and breastfeeding women on longitudinal clinical studies that require non-invasive biospecimen collection – a qualitative study
Authors
Dominick J. Lemas
Lauren Wright
Elizabeth Flood-Grady
Magda Francois
Lynn Chen
Austen Hentschel
Xinsong Du
Chu J. Hsiao
Huan Chen
Josef Neu
Ryan P. Theis
Elizabeth Shenkman
Janice Krieger
Publication date
01-12-2021
Publisher
BioMed Central
Keyword
Lactation
Published in
BMC Pregnancy and Childbirth / Issue 1/2021
Electronic ISSN: 1471-2393
DOI
https://doi.org/10.1186/s12884-021-03541-x

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