dc0cc8c7105871bdac440480a03a1628 322742.pdf edc24ee34c2d46ad089a77e071f47ce733493c3d 322742.pdf 5e7187878e041d3b3ccb438d37258b4875e25b96618851f5b80b6707363330d2 322742.pdf Title: The Effect of Probiotics on Preterm Birth Rates in Pregnant Women After a Threatened Preterm Birth Episode (The PROPEV Trial) Subject: Introduction: Preterm birth is the leading cause of perinatal mortality worldwide, with prevalence rates showing little reduction. Although mortality rates have decreased, morbidity rates remain concerningly high. In recent years, there has been a surge in studies examining the etiology, risk factors, and management of preterm birth. The use of vaginal probiotics in pregnant women at risk of preterm birth has garnered attention as a potential approach for improving perinatal outcomes and modulating the vaginal microbiota. However, the efficacy of this intervention remains unclear. Therefore, this study explored the impact of vaginal probiotics on perinatal outcomes and vaginal microbiota composition in pregnant women at risk of preterm birth. Materials and Methods: This was a randomized, prospective, longitudinal, double-blind, placebo-controlled, multicentric trial conducted across seven maternities in Spain from October 2017 to August 2022 in pregnant women at risk of preterm birth. Participants were randomly assigned to receive vaginal probiotics containing four lactobacilli strains or a placebo. The primary outcome was to explore a potential correlation between probiotic use among pregnant women at risk of preterm birth and the actual rate of preterm birth before 37 gestational weeks. Secondary outcomes included an evaluation of preterm birth rates, neonatal morbidity, the vaginal microbiota, and changes in the vaginal microbiota after receiving probiotics. Other secondary outcomes were identifying vaginal microbiota patterns associated with preterm birth and exploring potential therapeutic mechanisms involving probiotics. Trial registration: Clinicaltrials.gov, identifier: NCT03689166. Results: A total of 200 participants were included. Of those, birth data were obtained for 181 women. Demographics were similar between both groups. An analysis of perinatal outcomes found no significant differences in preterm birth rates, prematurity rates, gestational weeks at delivery, neonatal complications, time to birth, or latency time to delivery. Microbiota analysis showed no significant differences in vaginal microbiota changes between groups. No serious or unexpected adverse reactions were reported. Conclusions: There were no statistically significant differences for spontaneous preterm birth between pregnant women receiving probiotics and pregnant women receiving the placebo. Keywords: prematurity; preterm birth; microbiota; probiotics; Lactobacillus Author: Ester del Barco, Leidy-Alejandra G. Molano, Mireia Vargas, Marta Miserachs, Linda Puerto, Carmen Garrido-Giménez, Zaida Soler, Begoña Muñoz, Laia Pratcorona, Sonia Rimbaut, Mercè Vidal, Marta Dalmau, Alba Casellas, Elena Carreras, Chaysavanh Manichanh and Maria Goya Creator: LaTeX with hyperref Producer: pdfTeX-1.40.25 CreationDate: Thu May 8 12:53:26 2025 CEST ModDate: Thu May 8 12:56:10 2025 CEST Custom Metadata: no Metadata Stream: no Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 17 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 2394088 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- WYEKQU+VnURWPalladioL-Bold Type 1 Custom yes yes yes 10 0 CWELPT+VnURWPalladioL Type 1 Custom yes yes yes 16 0 ZXJECX+URWPalladioL-Roma Type 1 Custom yes yes yes 21 0 XBIPSQ+URWPalladioL-Bold Type 1 Custom yes yes yes 27 0 JFQZXE+URWPalladioL-Ital Type 1 Custom yes yes yes 32 0 COGLGI+CMSY10 Type 1 Builtin yes yes yes 61 0 OVNEXW+EURM10 Type 1 Builtin yes yes yes 72 0 QLBIEB+URWPalladioL-BoldItal Type 1 Custom yes yes yes 83 0 OIHOGK+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 95 0 OIHOGL+PalatinoLinotype CID TrueType Identity-H yes yes yes 98 0 OIHOHM+PalatinoLinotype TrueType WinAnsi yes yes no 104 0 OIHOHO+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 107 0 OIIAHF+PalatinoLinotype,BoldItalic TrueType WinAnsi yes yes no 110 0 OIIBKO+PalatinoLinotype,Italic TrueType MacRoman yes yes no 127 0 OIHOGK+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 130 0 OIHOGL+PalatinoLinotype CID TrueType Identity-H yes yes yes 133 0 OIHOHM+PalatinoLinotype TrueType WinAnsi yes yes no 139 0 OIHOHO+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 142 0 OIHPBL+PalatinoLinotype TrueType MacRoman yes yes no 145 0 OIHOGK+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 156 0 OIHOGL+PalatinoLinotype CID TrueType Identity-H yes yes yes 159 0 OIHOHM+PalatinoLinotype TrueType WinAnsi yes yes no 165 0 OIHOHO+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 168 0 OIHOGK+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 183 0 OIHOHM+PalatinoLinotype TrueType WinAnsi yes yes no 186 0 OIHOHO+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 189 0 OIIAHF+PalatinoLinotype,BoldItalic TrueType WinAnsi yes yes no 192 0 OIHOGJ+PalatinoLinotype,Bold CID TrueType Identity-H yes yes yes 207 0 OIHOGK+PalatinoLinotype,Bold TrueType WinAnsi yes yes no 213 0 OIHOHM+PalatinoLinotype TrueType WinAnsi yes yes no 216 0 OIHOHO+PalatinoLinotype,Italic TrueType WinAnsi yes yes no 219 0 OIHPBL+PalatinoLinotype TrueType MacRoman yes yes no 222 0 Jhove (Rel. 1.28.0, 2023-05-18) Date: 2026-02-10 04:11:47 CET RepresentationInformation: 322742.pdf ReportingModule: PDF-hul, Rel. 1.12.4 (2023-03-16) LastModified: 2026-02-09 14:32:23 CET Size: 2394088 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 405 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Destination: section.1 Item: Title: Material and Methods Destination: section.2 Children: Item: Title: Study Design and Participants Destination: subsection.2.1 Item: Title: Sample Size Destination: subsection.2.2 Item: Title: Procedures, Randomization, and Masking Destination: subsection.2.3 Item: Title: Outcomes Destination: subsection.2.4 Item: Title: Statistical Analysis Destination: subsection.2.5 Item: Title: DNA Extraction and 16S rRNA Sequencing Destination: subsection.2.6 Item: Title: Microbiota Analysis Destination: subsection.2.7 Item: Title: Results Destination: section.3 Children: Item: Title: Microbiota Analysis Destination: subsection.3.1 Item: Title: Safety Management Destination: subsection.3.2 Item: Title: Discussion Destination: section.4 Item: Title: Conclusions Destination: section.5 Item: Title: References Destination: section.6 Info: Title: The Effect of Probiotics on Preterm Birth Rates in Pregnant Women After a Threatened Preterm Birth Episode (The PROPEV Trial) Author: Ester del Barco, Leidy-Alejandra G. Molano, Mireia Vargas, Marta Miserachs, Linda Puerto, Carmen Garrido-Giménez, Zaida Soler, Begoña Muñoz, Laia Pratcorona, Sonia Rimbaut, Mercè Vidal, Marta Dalmau, Alba Casellas, Elena Carreras, Chaysavanh Manichanh and Maria Goya Subject: Introduction: Preterm birth is the leading cause of perinatal mortality worldwide, with prevalence rates showing little reduction. Although mortality rates have decreased, morbidity rates remain concerningly high. In recent years, there has been a surge in studies examining the etiology, risk factors, and management of preterm birth. The use of vaginal probiotics in pregnant women at risk of preterm birth has garnered attention as a potential approach for improving perinatal outcomes and modulating the vaginal microbiota. However, the efficacy of this intervention remains unclear. Therefore, this study explored the impact of vaginal probiotics on perinatal outcomes and vaginal microbiota composition in pregnant women at risk of preterm birth. Materials and Methods: This was a randomized, prospective, longitudinal, double-blind, placebo-controlled, multicentric trial conducted across seven maternities in Spain from October 2017 to August 2022 in pregnant women at risk of preterm birth. Participants were randomly assigned to receive vaginal probiotics containing four lactobacilli strains or a placebo. The primary outcome was to explore a potential correlation between probiotic use among pregnant women at risk of preterm birth and the actual rate of preterm birth before 37 gestational weeks. Secondary outcomes included an evaluation of preterm birth rates, neonatal morbidity, the vaginal microbiota, and changes in the vaginal microbiota after receiving probiotics. Other secondary outcomes were identifying vaginal microbiota patterns associated with preterm birth and exploring potential therapeutic mechanisms involving probiotics. Trial registration: Clinicaltrials.gov, identifier: NCT03689166. Results: A total of 200 participants were included. Of those, birth data were obtained for 181 women. Demographics were similar between both groups. An analysis of perinatal outcomes found no significant differences in preterm birth rates, prematurity rates, gestational weeks at delivery, neonatal complications, time to birth, or latency time to delivery. Microbiota analysis showed no significant differences in vaginal microbiota changes between groups. No serious or unexpected adverse reactions were reported. Conclusions: There were no statistically significant differences for spontaneous preterm birth between pregnant women receiving probiotics and pregnant women receiving the placebo. 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