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Clinical experience with misoprostol vaginal insert for induction of labor: a prospective clinical observational study

PURPOSE: To provide real-world evidence using misoprostol vaginal insert (MVI) for induction of labor in nulliparous and parous women at two German Level I Centers in a prospective observational study. METHODS: Between 1 August 2014 and 1 October 2015, eligible pregnant women (≥ 36 + 0 weeks of gest...

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Autores principales: Schmidt, Markus, Neophytou, Maria, Hars, Olaf, Freudenberg, Julia, Kühnert, Maritta
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6328513/
https://www.ncbi.nlm.nih.gov/pubmed/30374645
http://dx.doi.org/10.1007/s00404-018-4942-y
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author Schmidt, Markus
Neophytou, Maria
Hars, Olaf
Freudenberg, Julia
Kühnert, Maritta
author_facet Schmidt, Markus
Neophytou, Maria
Hars, Olaf
Freudenberg, Julia
Kühnert, Maritta
author_sort Schmidt, Markus
collection PubMed
description PURPOSE: To provide real-world evidence using misoprostol vaginal insert (MVI) for induction of labor in nulliparous and parous women at two German Level I Centers in a prospective observational study. METHODS: Between 1 August 2014 and 1 October 2015, eligible pregnant women (≥ 36 + 0 weeks of gestation) requiring labor induction were treated with MVI. Endpoints included time to and mode of delivery rates of tocolysis use, tachysystole, uterine hypertonus or uterine hyperstimulation syndrome and newborn outcomes. RESULTS: Of the 354 women enrolled, 68.9% (244/354) achieved vaginal delivery (nulliparous, 139/232 [59.9%]; parous 105/122 [86.1%]; p < 0.001). Median time from MVI administration to vaginal delivery was 14.0 h (nulliparous, 14.5 h; parous, 11.9 h; p < 0.001). A total of 205/244 (84.0%) and 228/244 (93.4%) women achieved a vaginal delivery within 24 h and 30 h, respectively. The most common indications for cesarean delivery were pathologic cardiotocography (nulliparous, 41/232 [17.4%]; parous, 13/122 [10.7%]; p = 0.081) and arrested labor (dilation or descent; nulliparous, 45/232 [19.4%], parous, 3/122 [2.5%]; p ≤ 0.001). A total of 24.3% of women experienced uterine tachysystole and 9.6% experienced uterine tachysystole with fetal heart rate involvement, neither of which were significantly different for nulliparous and parous women. In total, 42/345 (12.2%) of the neonates had an arterial pH < 7.15 and 12/345 3.5% had a 5-min Apgar score ≤ 7. CONCLUSION: When clinically indicated, MVI was efficient and safe for induction of labor in women with an unfavorable cervix. Women, however, should be counseled regarding the risk of uterine tachysystole prior to labor induction with MVI.
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spelling pubmed-63285132019-01-25 Clinical experience with misoprostol vaginal insert for induction of labor: a prospective clinical observational study Schmidt, Markus Neophytou, Maria Hars, Olaf Freudenberg, Julia Kühnert, Maritta Arch Gynecol Obstet Maternal-Fetal Medicine PURPOSE: To provide real-world evidence using misoprostol vaginal insert (MVI) for induction of labor in nulliparous and parous women at two German Level I Centers in a prospective observational study. METHODS: Between 1 August 2014 and 1 October 2015, eligible pregnant women (≥ 36 + 0 weeks of gestation) requiring labor induction were treated with MVI. Endpoints included time to and mode of delivery rates of tocolysis use, tachysystole, uterine hypertonus or uterine hyperstimulation syndrome and newborn outcomes. RESULTS: Of the 354 women enrolled, 68.9% (244/354) achieved vaginal delivery (nulliparous, 139/232 [59.9%]; parous 105/122 [86.1%]; p < 0.001). Median time from MVI administration to vaginal delivery was 14.0 h (nulliparous, 14.5 h; parous, 11.9 h; p < 0.001). A total of 205/244 (84.0%) and 228/244 (93.4%) women achieved a vaginal delivery within 24 h and 30 h, respectively. The most common indications for cesarean delivery were pathologic cardiotocography (nulliparous, 41/232 [17.4%]; parous, 13/122 [10.7%]; p = 0.081) and arrested labor (dilation or descent; nulliparous, 45/232 [19.4%], parous, 3/122 [2.5%]; p ≤ 0.001). A total of 24.3% of women experienced uterine tachysystole and 9.6% experienced uterine tachysystole with fetal heart rate involvement, neither of which were significantly different for nulliparous and parous women. In total, 42/345 (12.2%) of the neonates had an arterial pH < 7.15 and 12/345 3.5% had a 5-min Apgar score ≤ 7. CONCLUSION: When clinically indicated, MVI was efficient and safe for induction of labor in women with an unfavorable cervix. Women, however, should be counseled regarding the risk of uterine tachysystole prior to labor induction with MVI. Springer Berlin Heidelberg 2018-10-29 2019 /pmc/articles/PMC6328513/ /pubmed/30374645 http://dx.doi.org/10.1007/s00404-018-4942-y Text en © The Author(s) 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Maternal-Fetal Medicine
Schmidt, Markus
Neophytou, Maria
Hars, Olaf
Freudenberg, Julia
Kühnert, Maritta
Clinical experience with misoprostol vaginal insert for induction of labor: a prospective clinical observational study
title Clinical experience with misoprostol vaginal insert for induction of labor: a prospective clinical observational study
title_full Clinical experience with misoprostol vaginal insert for induction of labor: a prospective clinical observational study
title_fullStr Clinical experience with misoprostol vaginal insert for induction of labor: a prospective clinical observational study
title_full_unstemmed Clinical experience with misoprostol vaginal insert for induction of labor: a prospective clinical observational study
title_short Clinical experience with misoprostol vaginal insert for induction of labor: a prospective clinical observational study
title_sort clinical experience with misoprostol vaginal insert for induction of labor: a prospective clinical observational study
topic Maternal-Fetal Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6328513/
https://www.ncbi.nlm.nih.gov/pubmed/30374645
http://dx.doi.org/10.1007/s00404-018-4942-y
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