The Effect of Probiotics on Preterm Birth Rates in Pregnant Women After a Threatened Preterm Birth Episode (The PROPEV Trial)

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 factor...

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Autores: del Barco, E., Molano, L.A.G.|||0000-0003-0069-6098, Vargas Buján, Mireia|||0000-0002-4980-7652, Miserachs, M.|||0000-0002-7946-3635, Puerto Tamayo, Linda Grace|||0000-0001-5539-6397, Garrido-Giménez, Carmen|||0000-0003-2180-1715, Soler, Z., Muñoz, B., Pratcorona, L., Rimbaut, S., Vidal, M., Dalmau, M., Casellas, A., Carreras, Enric|||0000-0002-3134-9964, Manichanh, Chaysavanh|||0000-0002-2287-4003, Goya, M.|||0000-0003-4001-2017
Tipo de recurso: artículo
Fecha de publicación:2025
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:322742
Acceso en línea:https://ddd.uab.cat/record/322742
https://dx.doi.org/urn:doi:10.3390/biomedicines13051141
Access Level:acceso abierto
Palabra clave:Lactobacillus
microbiota
prematurity
preterm birth
probiotics
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spelling The Effect of Probiotics on Preterm Birth Rates in Pregnant Women After a Threatened Preterm Birth Episode (The PROPEV Trial)del Barco, E.Molano, L.A.G.|||0000-0003-0069-6098Vargas Buján, Mireia|||0000-0002-4980-7652Miserachs, M.|||0000-0002-7946-3635Puerto Tamayo, Linda Grace|||0000-0001-5539-6397Garrido-Giménez, Carmen|||0000-0003-2180-1715Soler, Z.Muñoz, B.Pratcorona, L.Rimbaut, S.Vidal, M.Dalmau, M.Casellas, A.Carreras, Enric|||0000-0002-3134-9964Manichanh, Chaysavanh|||0000-0002-2287-4003Goya, M.|||0000-0003-4001-2017Lactobacillusmicrobiotaprematuritypreterm birthprobioticsIntroduction: 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.Universitat Autònoma de Barcelona. Departament de Medicina 22025-01-0120252025-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/322742https://dx.doi.org/urn:doi:10.3390/biomedicines13051141reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengInstituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI19/00287Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI20/00130open accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.https://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:3227422026-06-06T12:50:31Z
dc.title.none.fl_str_mv The Effect of Probiotics on Preterm Birth Rates in Pregnant Women After a Threatened Preterm Birth Episode (The PROPEV Trial)
title The Effect of Probiotics on Preterm Birth Rates in Pregnant Women After a Threatened Preterm Birth Episode (The PROPEV Trial)
spellingShingle The Effect of Probiotics on Preterm Birth Rates in Pregnant Women After a Threatened Preterm Birth Episode (The PROPEV Trial)
del Barco, E.
Lactobacillus
microbiota
prematurity
preterm birth
probiotics
title_short The Effect of Probiotics on Preterm Birth Rates in Pregnant Women After a Threatened Preterm Birth Episode (The PROPEV Trial)
title_full The Effect of Probiotics on Preterm Birth Rates in Pregnant Women After a Threatened Preterm Birth Episode (The PROPEV Trial)
title_fullStr The Effect of Probiotics on Preterm Birth Rates in Pregnant Women After a Threatened Preterm Birth Episode (The PROPEV Trial)
title_full_unstemmed The Effect of Probiotics on Preterm Birth Rates in Pregnant Women After a Threatened Preterm Birth Episode (The PROPEV Trial)
title_sort The Effect of Probiotics on Preterm Birth Rates in Pregnant Women After a Threatened Preterm Birth Episode (The PROPEV Trial)
dc.creator.none.fl_str_mv del Barco, E.
Molano, L.A.G.|||0000-0003-0069-6098
Vargas Buján, Mireia|||0000-0002-4980-7652
Miserachs, M.|||0000-0002-7946-3635
Puerto Tamayo, Linda Grace|||0000-0001-5539-6397
Garrido-Giménez, Carmen|||0000-0003-2180-1715
Soler, Z.
Muñoz, B.
Pratcorona, L.
Rimbaut, S.
Vidal, M.
Dalmau, M.
Casellas, A.
Carreras, Enric|||0000-0002-3134-9964
Manichanh, Chaysavanh|||0000-0002-2287-4003
Goya, M.|||0000-0003-4001-2017
author del Barco, E.
author_facet del Barco, E.
Molano, L.A.G.|||0000-0003-0069-6098
Vargas Buján, Mireia|||0000-0002-4980-7652
Miserachs, M.|||0000-0002-7946-3635
Puerto Tamayo, Linda Grace|||0000-0001-5539-6397
Garrido-Giménez, Carmen|||0000-0003-2180-1715
Soler, Z.
Muñoz, B.
Pratcorona, L.
Rimbaut, S.
Vidal, M.
Dalmau, M.
Casellas, A.
Carreras, Enric|||0000-0002-3134-9964
Manichanh, Chaysavanh|||0000-0002-2287-4003
Goya, M.|||0000-0003-4001-2017
author_role author
author2 Molano, L.A.G.|||0000-0003-0069-6098
Vargas Buján, Mireia|||0000-0002-4980-7652
Miserachs, M.|||0000-0002-7946-3635
Puerto Tamayo, Linda Grace|||0000-0001-5539-6397
Garrido-Giménez, Carmen|||0000-0003-2180-1715
Soler, Z.
Muñoz, B.
Pratcorona, L.
Rimbaut, S.
Vidal, M.
Dalmau, M.
Casellas, A.
Carreras, Enric|||0000-0002-3134-9964
Manichanh, Chaysavanh|||0000-0002-2287-4003
Goya, M.|||0000-0003-4001-2017
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universitat Autònoma de Barcelona. Departament de Medicina
dc.subject.none.fl_str_mv Lactobacillus
microbiota
prematurity
preterm birth
probiotics
topic Lactobacillus
microbiota
prematurity
preterm birth
probiotics
description 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.
publishDate 2025
dc.date.none.fl_str_mv 2
2025-01-01
2025
2025-01-01
dc.type.none.fl_str_mv Article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://ddd.uab.cat/record/322742
https://dx.doi.org/urn:doi:10.3390/biomedicines13051141
url https://ddd.uab.cat/record/322742
https://dx.doi.org/urn:doi:10.3390/biomedicines13051141
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.relation.none.fl_str_mv Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI19/00287
Instituto de Salud Carlos III https://doi.org/10.13039/501100004587 PI20/00130
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Dipòsit Digital de Documents de la UAB
instname:Universitat Autònoma de Barcelona
instname_str Universitat Autònoma de Barcelona
reponame_str Dipòsit Digital de Documents de la UAB
collection Dipòsit Digital de Documents de la UAB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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