Zhu, Bin https://orcid.org/0000-0003-2829-2925
Edwards, David J.
Spaine, Katherine M.
Edupuganti, Laahirie
Matveyev, Andrey
Serrano, Myrna G. https://orcid.org/0000-0003-4327-0193
Buck, Gregory A. https://orcid.org/0000-0003-4621-3987
Funding for this research was provided by:
Foundation for the National Institutes of Health (UH3AI083263, U54HD080784, R01HD092415)
Article History
Received: 11 December 2023
Accepted: 23 May 2024
First Online: 19 June 2024
Competing interests
: G.A.B. is a member of the Scientific Advisory Board of Juno, LTD.; a startup biotech firm focused on using the vaginal microbiome to address issues of women’s gynecologic and reproductive health. The remaining authors declare no competing interests.
: Participants were enrolled in the Multi-Omic Microbiome Study: Pregnancy Initiative (MOMS-PI) and the Vaginal Human Microbiome Project under the umbrella of the National Institutes of Health Human Microbiome Project (). Women were enrolled in women’s clinics associated with the Virginia Commonwealth University Health Center. Study protocols were approved by the Virginia Commonwealth University institutional review board under protocols IRB# HM12169 or HM15527. Written informed consent or parental permission and assent were provided by participants or minors older than 15 years, respectively. Exclusion criteria included women incapable of understanding the informed consent or assent forms or who were incarcerated. Demographic, health histories, dietary assessments, and clinical data (e.g., gestational age, height, weight, blood pressure, vaginal pH, diagnosis, etc.) were collected. Clinical information about neonates was collected at birth (day 0) and at 24–48 h (day 1) or 48–72 h (day 2) after birth. Other exclusion criteria included: (1) inability to self-sample due to any reason; (2) significant vaginal bleeding; (3) ruptured membranes; (4) herpes lesions.