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Effectiveness of Progestogens as Maintenance Tocolysis and Urogenital Cultures: Secondary Analysis of the PROTECT Trial
Background In a recently published multicenter randomized controlled trial, we demonstrated that progestogens are not effective as maintenance tocolysis. Objective This study was aimed to evaluate if previous finding may be affected by positive urine culture and/or vaginal swab. Study Design We p...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Thieme Medical Publishers
2020
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7571568/ https://www.ncbi.nlm.nih.gov/pubmed/33094004 http://dx.doi.org/10.1055/s-0040-1713788 |
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author | Pignatti, Lucrezia D'Amico, Roberto Vergani, Patrizia Di Tommaso, Mariarosaria Acaia, Barbara Benedetto, Chiara Facchinetti, Fabio |
author_facet | Pignatti, Lucrezia D'Amico, Roberto Vergani, Patrizia Di Tommaso, Mariarosaria Acaia, Barbara Benedetto, Chiara Facchinetti, Fabio |
author_sort | Pignatti, Lucrezia |
collection | PubMed |
description | Background In a recently published multicenter randomized controlled trial, we demonstrated that progestogens are not effective as maintenance tocolysis. Objective This study was aimed to evaluate if previous finding may be affected by positive urine culture and/or vaginal swab. Study Design We performed a secondary analysis of the PROTECT trial (NCT01178788). Women with singleton pregnancy between 22 and 31 (6/7) weeks' gestation, admitted for threatened preterm labor were considered. At admission, we collected urine culture and vaginal swabs. At discharge, women with a cervical length ≤25 mm were randomized to vaginal progesterone or 17α-hydroxyprogesterone caproate or observation group. We used Chi-square statistics, considering 97.5% CI (confidence interval) and p -value less than 0.025 for significance. Results Urine culture and vaginal swabs were collected in 232 out of 235 patients included in the primary analysis. Overall, 31 out of 232 women (13.4%) had positive urine culture and 60 out of 232 (25.9%) had positive vaginal swab. In women with negative urine culture, a higher rate of preterm birth was found in vaginal progesterone group (27/69, 39.7%) respect with controls (14/68, 20.6%; relative risk [RR] = 1.90; 97.5% CI: 1.01–3.57; p = 0.018). Conclusion Among women with negative urine culture, the rate of preterm birth <37 weeks' gestation was significantly increased in those receiving vaginal progesterone, reinforcing our previous findings in symptomatic women. |
format | Online Article Text |
id | pubmed-7571568 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Thieme Medical Publishers |
record_format | MEDLINE/PubMed |
spelling | pubmed-75715682020-10-21 Effectiveness of Progestogens as Maintenance Tocolysis and Urogenital Cultures: Secondary Analysis of the PROTECT Trial Pignatti, Lucrezia D'Amico, Roberto Vergani, Patrizia Di Tommaso, Mariarosaria Acaia, Barbara Benedetto, Chiara Facchinetti, Fabio AJP Rep Background In a recently published multicenter randomized controlled trial, we demonstrated that progestogens are not effective as maintenance tocolysis. Objective This study was aimed to evaluate if previous finding may be affected by positive urine culture and/or vaginal swab. Study Design We performed a secondary analysis of the PROTECT trial (NCT01178788). Women with singleton pregnancy between 22 and 31 (6/7) weeks' gestation, admitted for threatened preterm labor were considered. At admission, we collected urine culture and vaginal swabs. At discharge, women with a cervical length ≤25 mm were randomized to vaginal progesterone or 17α-hydroxyprogesterone caproate or observation group. We used Chi-square statistics, considering 97.5% CI (confidence interval) and p -value less than 0.025 for significance. Results Urine culture and vaginal swabs were collected in 232 out of 235 patients included in the primary analysis. Overall, 31 out of 232 women (13.4%) had positive urine culture and 60 out of 232 (25.9%) had positive vaginal swab. In women with negative urine culture, a higher rate of preterm birth was found in vaginal progesterone group (27/69, 39.7%) respect with controls (14/68, 20.6%; relative risk [RR] = 1.90; 97.5% CI: 1.01–3.57; p = 0.018). Conclusion Among women with negative urine culture, the rate of preterm birth <37 weeks' gestation was significantly increased in those receiving vaginal progesterone, reinforcing our previous findings in symptomatic women. Thieme Medical Publishers 2020-07 2020-08-04 /pmc/articles/PMC7571568/ /pubmed/33094004 http://dx.doi.org/10.1055/s-0040-1713788 Text en https://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License, which permits unrestricted reproduction and distribution, for non-commercial purposes only; and use and reproduction, but not distribution, of adapted material for non-commercial purposes only, provided the original work is properly cited. |
spellingShingle | Pignatti, Lucrezia D'Amico, Roberto Vergani, Patrizia Di Tommaso, Mariarosaria Acaia, Barbara Benedetto, Chiara Facchinetti, Fabio Effectiveness of Progestogens as Maintenance Tocolysis and Urogenital Cultures: Secondary Analysis of the PROTECT Trial |
title | Effectiveness of Progestogens as Maintenance Tocolysis and Urogenital Cultures: Secondary Analysis of the PROTECT Trial |
title_full | Effectiveness of Progestogens as Maintenance Tocolysis and Urogenital Cultures: Secondary Analysis of the PROTECT Trial |
title_fullStr | Effectiveness of Progestogens as Maintenance Tocolysis and Urogenital Cultures: Secondary Analysis of the PROTECT Trial |
title_full_unstemmed | Effectiveness of Progestogens as Maintenance Tocolysis and Urogenital Cultures: Secondary Analysis of the PROTECT Trial |
title_short | Effectiveness of Progestogens as Maintenance Tocolysis and Urogenital Cultures: Secondary Analysis of the PROTECT Trial |
title_sort | effectiveness of progestogens as maintenance tocolysis and urogenital cultures: secondary analysis of the protect trial |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7571568/ https://www.ncbi.nlm.nih.gov/pubmed/33094004 http://dx.doi.org/10.1055/s-0040-1713788 |
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