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Labor induction with randomized comparison of cervical, oral and intravaginal misoprostol
BACKGROUND: This study attempts to evaluate the safety and effectiveness of 50μgm intracervical misoprostol in comparison with intravaginal and sublingual for the induction of labor at term pregnant women. METHODS: This study is designed as a parallel clinical trial study. Three hundred and fifteen...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2021
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8549163/ https://www.ncbi.nlm.nih.gov/pubmed/34706675 http://dx.doi.org/10.1186/s12884-021-04196-4 |
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author | Dadashaliha, Masoumeh Fallah, Somayeh Mirzadeh, Monirsadat |
author_facet | Dadashaliha, Masoumeh Fallah, Somayeh Mirzadeh, Monirsadat |
author_sort | Dadashaliha, Masoumeh |
collection | PubMed |
description | BACKGROUND: This study attempts to evaluate the safety and effectiveness of 50μgm intracervical misoprostol in comparison with intravaginal and sublingual for the induction of labor at term pregnant women. METHODS: This study is designed as a parallel clinical trial study. Three hundred and fifteen term pregnancies requiring induction of labor were treated with the maximum used misoprostol intracervical, sublingual, and vaginal doses. Participants were randomly allocated into three groups of 105. The dose was repeated every 4 h until adequate uterine contraction and Bishop Score were achieved. The duration of induction to births, time to the active phase, the rate of births, and the need for caesarean section were compared in three groups. Additionally, labor course and side effects were recorded and analyzed. Data were analyzed using SPSS software. A significance level of p < 0.05 was considered for statistical analyses. FINDINGS: Labor was successfully induced in all cases most (63%) of which required a single dose of misoprostol. Ninety-three (93.0%, p < 0.05) cervical participants proceeded to vaginal births. This figure was also the same in the vaginal and sublingual group of 83 cases (83.0%). The other 41 cases received caesarean section with more indications of failure to progress and meconium-stained liquor. The results indicated that 278 (92.7%) births were achieved in less than 10 h. Time from start of medication to the active phase of labor and childbirth was 3.01 ± 0.86 and 6.1 ± 1.3 h in the Cervical group, 4.2 ± 0.66 and 8.4 ± 0.92 h in the sublingual group, and 5.06 ± 1.1 and 9.2 ± 1.5 h in the vaginal group respectively (p < 0.001). The Caesarean rate was lower in the cervical group than in the two other groups (p = 0.05). No significant differences were observed between the study groups in terms of Apgar score and meconium-stained amniotic fluid. Furthermore, no maternal and neonatal complications were observed. CONCLUSION: In addition to the sublingual and intravaginal routes of administration, intracervical misoprostol at a single dose of 50μgm appears to be an effective method for induction of labor in women with an unfavorable cervix. Like all medical interventions, a discussion of the risks, benefits, and alternatives to induction of labor with this medication in each woman should be undertaken before treatment. TRIAL REGISTRATION: This clinical study was approved by the Iranian Registry of Clinical Trials with IRCT ID: IRCT20190415043278N1. Registration date was on May 13, 2019 and May 27, 2019 respectively (http://www.irct.ir). |
format | Online Article Text |
id | pubmed-8549163 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-85491632021-10-27 Labor induction with randomized comparison of cervical, oral and intravaginal misoprostol Dadashaliha, Masoumeh Fallah, Somayeh Mirzadeh, Monirsadat BMC Pregnancy Childbirth Research Article BACKGROUND: This study attempts to evaluate the safety and effectiveness of 50μgm intracervical misoprostol in comparison with intravaginal and sublingual for the induction of labor at term pregnant women. METHODS: This study is designed as a parallel clinical trial study. Three hundred and fifteen term pregnancies requiring induction of labor were treated with the maximum used misoprostol intracervical, sublingual, and vaginal doses. Participants were randomly allocated into three groups of 105. The dose was repeated every 4 h until adequate uterine contraction and Bishop Score were achieved. The duration of induction to births, time to the active phase, the rate of births, and the need for caesarean section were compared in three groups. Additionally, labor course and side effects were recorded and analyzed. Data were analyzed using SPSS software. A significance level of p < 0.05 was considered for statistical analyses. FINDINGS: Labor was successfully induced in all cases most (63%) of which required a single dose of misoprostol. Ninety-three (93.0%, p < 0.05) cervical participants proceeded to vaginal births. This figure was also the same in the vaginal and sublingual group of 83 cases (83.0%). The other 41 cases received caesarean section with more indications of failure to progress and meconium-stained liquor. The results indicated that 278 (92.7%) births were achieved in less than 10 h. Time from start of medication to the active phase of labor and childbirth was 3.01 ± 0.86 and 6.1 ± 1.3 h in the Cervical group, 4.2 ± 0.66 and 8.4 ± 0.92 h in the sublingual group, and 5.06 ± 1.1 and 9.2 ± 1.5 h in the vaginal group respectively (p < 0.001). The Caesarean rate was lower in the cervical group than in the two other groups (p = 0.05). No significant differences were observed between the study groups in terms of Apgar score and meconium-stained amniotic fluid. Furthermore, no maternal and neonatal complications were observed. CONCLUSION: In addition to the sublingual and intravaginal routes of administration, intracervical misoprostol at a single dose of 50μgm appears to be an effective method for induction of labor in women with an unfavorable cervix. Like all medical interventions, a discussion of the risks, benefits, and alternatives to induction of labor with this medication in each woman should be undertaken before treatment. TRIAL REGISTRATION: This clinical study was approved by the Iranian Registry of Clinical Trials with IRCT ID: IRCT20190415043278N1. Registration date was on May 13, 2019 and May 27, 2019 respectively (http://www.irct.ir). BioMed Central 2021-10-27 /pmc/articles/PMC8549163/ /pubmed/34706675 http://dx.doi.org/10.1186/s12884-021-04196-4 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Article Dadashaliha, Masoumeh Fallah, Somayeh Mirzadeh, Monirsadat Labor induction with randomized comparison of cervical, oral and intravaginal misoprostol |
title | Labor induction with randomized comparison of cervical, oral and intravaginal misoprostol |
title_full | Labor induction with randomized comparison of cervical, oral and intravaginal misoprostol |
title_fullStr | Labor induction with randomized comparison of cervical, oral and intravaginal misoprostol |
title_full_unstemmed | Labor induction with randomized comparison of cervical, oral and intravaginal misoprostol |
title_short | Labor induction with randomized comparison of cervical, oral and intravaginal misoprostol |
title_sort | labor induction with randomized comparison of cervical, oral and intravaginal misoprostol |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8549163/ https://www.ncbi.nlm.nih.gov/pubmed/34706675 http://dx.doi.org/10.1186/s12884-021-04196-4 |
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