Several lines of evidence suggest that children born via Cesarean section (C-section) are at greater risk for adverse health outcomes including allergies, asthma and obesity. Vaginal seeding is a medical procedure in which infants born by C-section are swabbed immediately after birth with vaginal secretions from the mother. This procedure has been proposed as a way to transfer the mother's vaginal microbiome to the child, thereby restoring the natural exposure that occurs during vaginal birth that is interrupted in the case of babies born via C-section. Preliminary evidence indicates partial restoration of microbes. However, there is insufficient evidence to determine the health benefits of the procedure. Several studies, including trial, are currently underway. At the same time, in the clinic setting, doctors are increasingly being asked to by expectant mothers to have their babies seeded. This article reports on the current research on this procedure and the issues it raises for regulators, researchers, physicians, and patients.
Get full access to this article
View all access options for this article.
References
1.
T.Boerma, C.Ronsmans, and D.Y.Melesseet al., “Global Epidemiology of Use of and Disparities in Caesarean Sections,”Lancet392 (2018): 1341–1348.
G.H.A.Visser, D.Ayres de Campos, and E.R.Barneaet al., “FIGO Position Paper: How to Stop the Caesarean Section Epidemic,”Lancet392 (2018): 1286–1287.
5.
J.Sandall, R.M.Tribe, and L.Averyet al., “Short-Term and Long-Term Effects of Caesarean Section on the Health of Women and Children,”Lancet392 (2018):1349–1357.
6.
N.T.Mueller, M.Zhang, C.Hoyo, T.Østbye, and S.E.Benjamin-Neelon, “Does Cesarean Delivery Impact Infant Weight Gain and Adiposity Over the First Year of Life?”International Journal of Obesity43, no. 8 (2018): 1549–1555.
7.
S.Y.Huh, S.L.Rifas-Shiman, and C.A.Zeret al., “Delivery by Caesarean Section and the Risk of Obesity in Preschool Age Children: A Prospective Cohort Study,”Archives of Disease in Childhood97, no. 7 (2012): 610–616.
8.
K.Darmasseelane, M.J.Hyde, S.Santhakumaran, C.Gale, and N.Modi, “Mode of Delivery and Offspring Body Mass Index, Overweight and Obesity in Adult Life: A Systematic Review and Meta-Analysis,”PLoS One9, no. 2 (2014): e87896.
9.
S.Kuhle, O.S.Tong, and C.G.Woolcott, “Association Between Caesarean Section and Childhood Obesity: A Systematic Review and Meta-Analysis,”Obesity Review16, no. 4 (2015): 295–303.
10.
H.Renz-Polster, M.R.David, and A.S.Buistet al., “Caesarean Section Delivery and the Risk of Allergic Disorders in Childhood,”Clinical and Experimental Allergy35, no. 11 (2005): 1466–1472.
11.
A.Maitra, A.Sherriff, and D.Strachanet al., “Mode of Delivery is Not Associated with Asthma or Atopy in Childhood,”Clinical & Experimental Allergy34, no. 9 (2004): 1349–1355.
12.
A.Sevelsted, J.Stokholm, K.Bønnelykke, and H.Bisgaard, “Cesarean Section and Chronic Immune Disorders,”Pediatrics135, no. 1 (2015): e92–e98.
13.
N.Mitselou, J.Hallberg, and O.Stephanssonet al., “Cesarean Delivery, Preterm Birth, and Risk of Food Allergy: Nationwide Swedish Cohort Study of More than 1 Million Children,”Journal of Allergy and Clinical Immunology142, no. 5 (2018): 1510–14.e2.
14.
E.Mueller, E.Bakacs, J.Combellick, Z.Grigoryan, and M.G.Dominguez-Bello, “The Infant Microbiome Development: Mom Matters,”Trends in Molecular Medicine21, no. 2 (2015): 109–117.
15.
M.G.Dominguez-Bello, E.K.Costello, and M.Contreraset al., “Delivery Mode Shapes the Acquisition and Structure of the Initial Microbiota across Multiple Body Habitats in Newborns,”Proceedings of the National Academies of Science of the United States of America107, no. 26 (2010): 11971–11975.
16.
G.Iacobucci, “Sixty Seconds on … Vaginal Seeding,”BMJ352 (2016): i1095.
17.
M.G.Dominguez-Bello, K.M.De Jesus-Laboy, and N.Shenet al., “Partial Restoration of the Microbiota of Cesarean-Born Infants via Vaginal Microbial Transfer,”Nature Medicine22, no. 3 (2016): 250–253.
18.
Id.
19.
J.Huynh, P.Palasanthiran, and B.McMullan, “Potential Transmission of Herpes Simplex Virus via Vaginal Seeding,”The Pediatric Infectious Disease Journal37, no. 11 (2018): e278.
20.
A.J.Cunnington, K.Sim, A.Deierl, J.S.Kroll, E.Brannigan, and J.Darby, “‘Vaginal Seeding’ of Infants Born by Caesarean Section,”BMJ352 (2016): i227.
21.
Committee on Obstetric Practice, supra note 14.
22.
T.Haahr, J.Glavind, and P.Axelssonet al., “Vaginal Seeding or Vaginal Microbial Transfer from the Mother to the Caesarean-Born Neonate: A Commentary Regarding Clinical Management,”BJOG125, no. 5 (Apr. 2018): 533–536, doi: 10.1111/1471-0528.14792.
23.
T.Yatsunenko, F.E.Rey, and M.J.Manaryet al., “Human Gut Microbiome Viewed across Age and Geography,”Nature486, no. 7402 (2012): 222–227.
24.
Dominguez-Bello et al., supra note 15.
25.
Mueller, supra note 14; Haahr et al., supra note 22.
26.
Mueller, supra note 14.
27.
K.E.Gregory, R.D.LaPlante, G.Shan, D.V.Kumar, and M.Gregas, “Mode of Birth Influences Preterm Infant Intestinal Colonization with Bacteroides over the Early Neonatal Period,”Advances in Neonatal Care15, no. 6 (2015): 386–393.
28.
D.M.Chu, J.Ma, A.L.Prince, K.M.Antony, M.D.Seferovic, and K.M.Aagaard, “Maturation of the Infant Microbiome Community Structure and Function across Multiple Body Sites and in Relation to Mode of Delivery,”Nature Medicine23, no. 3 (2017): 314–326.
29.
Id.
30.
F.Fouhy, C.Watkins, and C.J.Hillet al., “Perinatal Factors Affect the Gut Microbiota up to Four Years after Birth,”Nature Communications10 (2019): art. no. 1517.
31.
L.M.Cox, S.Yamanishi, and J.Sohnet al., “Altering the Intestinal Microbiota During a Critical Developmental Window Has Lasting Metabolic Consequences,”Cell158, no. 4 (2014): 705–721.
32.
ClinicalTrials.gov Identifier: NCT03809390.
33.
ClinicalTrials.gov identifier: NCT03298334.
34.
Standard of care testing includes gonorrhea, chlamydia, hepatitis B, HIV, and syphilis.
Biological products are a subcategory of drugs, defined by FDA as “a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product … applicable to the prevention, treatment, or cure of a disease or condition of human beings.” 42 U.S.C. § 262(i).
U.S. Food & Drug Administration, Guidance for Clinical Investigators, Sponsors and IRBs, Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an IND, Sept. 2013, available at <https://www.fda.gov/downloads/drugs/guidances/ucm229175.pdf> (last visited October 1, 2019).
48.
21 U.S.C. § 379(a).
49.
836 F.3d 1199 (9th Cir. 2016).
50.
21 U.S.C. § 331(k).
51.
278 F.3d 926 (9th Cir. 2002).
52.
Kaplan, 836 F.3d at 1209.
53.
Id.
54.
741 F.3d 1314 (D.C. Cir. 2014).
55.
Id. at 1320.
56.
Id. at 1320–21 (citing United States v. Dianovin Pharmaceuticals, Inc., 475 F.2d 100 (1st Cir. 1973)).
57.
Kaplan, 836 F.3d at 1209 (citing United States v. Rhody Dairy, L.L.C., 812 F. Supp. 2d 1239, 1244 (W.D. Wash. 2011)) (“[S]everal cases have held that drugs and devices used in the treatment of patients are ‘held for sale’ by doctors as part of the distribution process.”); see also United States v. Evers, 643 F.2d 1043, 1050 (5th Cir. 1981) (“Doctors holding drugs for use in their practice are clearly one part of the distribution process, and doctors may therefore hold drugs for sale within the meaning of section 301(k) of the Act.”); United States v. Diapulse Corp. of Am., 514 F.2d 1097, 1098 (2d Cir. 1975) (per curiam) (“Such devices, used in the treatment of patients, may properly be considered ‘held for sale’ within the meaning of the [FDCA], 21 U.S.C. § 331(k).”); United States v. Device Labeled “Cameron Spitler Amblyo-Syntonizer,” 261 F. Supp. 243, 246 (D. Neb. 1966) (holding that a physician was not exempt from the requirements of the FDCA when he used misbranded devices in the treatment of his patients even though he did not sell the devices in the commercial sense).
58.
D.A.MacIntyre, M.Chandiramani, and Y.S.Leeet al., “The Vaginal Microbiome During Pregnancy and the Postpartum Period in a European Population,”Scientific Reports5 (2015): art. no. 8988.
59.
R.E.Sachs and C.A.Edelstein, “Ensuring the Safe and Effective FDA Regulation of Fecal Microbiota Transplantation,”Journal of Law and the Biosciences2, no. 2 (2015): 396–415.
60.
A.Khoruts, D.Hoffmann, and F.Palumbo, “The Impact of Regulatory Policies on the Future of Fecal Microbiota Transplantation,”Journal of Law, Medicine & Ethics47, no. 4 (2019): 482-504.
61.
Dominguez-Bello, supra note 17.
62.
I.S.E.van der Zande, R.van der Graaf, and M.A.Oudijket al., “Vulnerability of Pregnant Women in Clinical Research,”Journal of Medical Ethics43, no. 10 (2017): 657–663.
