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Progesterone Gel and Placebo Prolonged Pregnancy More Effectively Than Intravenous Tocolysis Alone in Women with Preterm Labor
The aim of this trial was to evaluate the effect of progesterone gel compared to placebo in prolonging pregnancy among women with preterm labor. Methods: A randomized controlled trial in Sweden in 2009–18. Women with early preterm labor were randomized to daily doses of progesterone gel 90 mg (n = 2...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9141710/ https://www.ncbi.nlm.nih.gov/pubmed/35621570 http://dx.doi.org/10.3390/gels8050272 |
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author | Vladic Stjernholm, Ylva Vladic, Tomislav Marchini, Giovanna |
author_facet | Vladic Stjernholm, Ylva Vladic, Tomislav Marchini, Giovanna |
author_sort | Vladic Stjernholm, Ylva |
collection | PubMed |
description | The aim of this trial was to evaluate the effect of progesterone gel compared to placebo in prolonging pregnancy among women with preterm labor. Methods: A randomized controlled trial in Sweden in 2009–18. Women with early preterm labor were randomized to daily doses of progesterone gel 90 mg (n = 28) or placebo (n = 30) after standard intravenous tocolytics. Women with intravenous tocolytics alone (n = 29) served as controls. Results: The median latency to delivery was 68 (range 28–88) days with progesterone and 72 (range 9–90) days with placebo (p = 0.84), compared to 1 (range 1–2) day in the control group (progesterone and placebo vs. control p < 0.001). The rate of preterm birth before 34 weeks was 32% after progesterone and 37 % after placebo (p = 0.32) compared to 100 % in the control group (p < 0.001, respectively). The composite neonatal morbidity (p = 0.65) and neonatal intensive care unit admission (p = 0.12) were comparable between the progesterone and placebo groups and lower in these groups compared with neonates in the control group (p < 0.001, respectively). Conclusions: Progesterone gel and placebo were equally effective in prolonging pregnancy among women with early preterm labor, and both treatments were more effective than standard intravenous tocolysis alone. We hypothesize that the acidic placebo gel reinforced the biochemical barrier at the uterine cervix, which counteracts ascending pathogen invasion and subsequent inflammation, and thereby prevented preterm labor. |
format | Online Article Text |
id | pubmed-9141710 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-91417102022-05-28 Progesterone Gel and Placebo Prolonged Pregnancy More Effectively Than Intravenous Tocolysis Alone in Women with Preterm Labor Vladic Stjernholm, Ylva Vladic, Tomislav Marchini, Giovanna Gels Article The aim of this trial was to evaluate the effect of progesterone gel compared to placebo in prolonging pregnancy among women with preterm labor. Methods: A randomized controlled trial in Sweden in 2009–18. Women with early preterm labor were randomized to daily doses of progesterone gel 90 mg (n = 28) or placebo (n = 30) after standard intravenous tocolytics. Women with intravenous tocolytics alone (n = 29) served as controls. Results: The median latency to delivery was 68 (range 28–88) days with progesterone and 72 (range 9–90) days with placebo (p = 0.84), compared to 1 (range 1–2) day in the control group (progesterone and placebo vs. control p < 0.001). The rate of preterm birth before 34 weeks was 32% after progesterone and 37 % after placebo (p = 0.32) compared to 100 % in the control group (p < 0.001, respectively). The composite neonatal morbidity (p = 0.65) and neonatal intensive care unit admission (p = 0.12) were comparable between the progesterone and placebo groups and lower in these groups compared with neonates in the control group (p < 0.001, respectively). Conclusions: Progesterone gel and placebo were equally effective in prolonging pregnancy among women with early preterm labor, and both treatments were more effective than standard intravenous tocolysis alone. We hypothesize that the acidic placebo gel reinforced the biochemical barrier at the uterine cervix, which counteracts ascending pathogen invasion and subsequent inflammation, and thereby prevented preterm labor. MDPI 2022-04-26 /pmc/articles/PMC9141710/ /pubmed/35621570 http://dx.doi.org/10.3390/gels8050272 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Vladic Stjernholm, Ylva Vladic, Tomislav Marchini, Giovanna Progesterone Gel and Placebo Prolonged Pregnancy More Effectively Than Intravenous Tocolysis Alone in Women with Preterm Labor |
title | Progesterone Gel and Placebo Prolonged Pregnancy More Effectively Than Intravenous Tocolysis Alone in Women with Preterm Labor |
title_full | Progesterone Gel and Placebo Prolonged Pregnancy More Effectively Than Intravenous Tocolysis Alone in Women with Preterm Labor |
title_fullStr | Progesterone Gel and Placebo Prolonged Pregnancy More Effectively Than Intravenous Tocolysis Alone in Women with Preterm Labor |
title_full_unstemmed | Progesterone Gel and Placebo Prolonged Pregnancy More Effectively Than Intravenous Tocolysis Alone in Women with Preterm Labor |
title_short | Progesterone Gel and Placebo Prolonged Pregnancy More Effectively Than Intravenous Tocolysis Alone in Women with Preterm Labor |
title_sort | progesterone gel and placebo prolonged pregnancy more effectively than intravenous tocolysis alone in women with preterm labor |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9141710/ https://www.ncbi.nlm.nih.gov/pubmed/35621570 http://dx.doi.org/10.3390/gels8050272 |
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