Lower Uterine Segment Trial: A pragmatic open multicenter randomized trial
International audience Background: The data from literature show that trial of labor and elective repeat cesarean delivery after a prior cesarean delivery both present significant risks and benefits, and these risks and benefits differ for the woman and her fetus. The benefits to the woman can be at...
Published in: | Gynécologie Obstétrique Fertilité & Sénologie |
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Online Access: | https://hal.science/hal-02560874 https://doi.org/10.1016/j.gofs.2018.03.005 |
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ftsorbonneuniv:oai:HAL:hal-02560874v1 2024-05-12T08:10:39+00:00 Lower Uterine Segment Trial: A pragmatic open multicenter randomized trial Prédiction échographique du risque de rupture utérine après césarienne: LUSTrial, un essai randomisé pragmatique Rozenberg, Patrick Deruelle, Philippe Sénat, Marie Victoire Desbrière, Raoul Winer, Norbert Simon, E. G. Ville, Yves G. Kayem, Gilles Boutron, Isabelle Risques cliniques et sécurité en santé des femmes et en santé périnatale (RISCQ) Université de Versailles Saint-Quentin-en-Yvelines (UVSQ) Hôpital Jeanne de Flandre Lille Hôpital Bicêtre Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Bicêtre AP-HP, Le Kremlin-Bicêtre Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP) Hôpital Saint-Joseph Marseille Hôpital Mère Enfant CHU Nantes Hôpital Bretonneau Centre Hospitalier Régional Universitaire de Tours (CHRU Tours) Hôpital Necker - Enfants Malades AP-HP CHU Trousseau APHP Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU) Hôpital Hôtel-Dieu Paris 2018 https://hal.science/hal-02560874 https://doi.org/10.1016/j.gofs.2018.03.005 en eng HAL CCSD Elsevier info:eu-repo/semantics/altIdentifier/doi/10.1016/j.gofs.2018.03.005 info:eu-repo/semantics/altIdentifier/pmid/29625873 hal-02560874 https://hal.science/hal-02560874 doi:10.1016/j.gofs.2018.03.005 PRODINRA: 485728 PUBMED: 29625873 ISSN: 2468-7197 EISSN: 2468-7189 Gynécologie Obstétrique Fertilité & Sénologie https://hal.science/hal-02560874 Gynécologie Obstétrique Fertilité & Sénologie, 2018, 46 (4), pp.427-432. ⟨10.1016/j.gofs.2018.03.005⟩ Uterine rupture Ultrasound Uterine dehiscence Ultrasonography Cesarean delivery Trial of labor [SDV]Life Sciences [q-bio] info:eu-repo/semantics/article Journal articles 2018 ftsorbonneuniv https://doi.org/10.1016/j.gofs.2018.03.005 2024-04-18T03:41:37Z International audience Background: The data from literature show that trial of labor and elective repeat cesarean delivery after a prior cesarean delivery both present significant risks and benefits, and these risks and benefits differ for the woman and her fetus. The benefits to the woman can be at the expense of her fetus and vice-versa. This uncertainty is compounded by the scarcity of high-level evidence that preclude accurate quantification of the risks and benefits that could help provide a fair counseling about a trial of labor and elective repeat cesarean delivery. An interesting way of research is to evaluate the potential benefits of a decision rule associated to the ultrasound measurement of the lower uterine segment (LUS). Indeed, ultrasonography may be helpful in determining a specific risk for a given patient by measuring the thickness of the LUS, i,e, the thickness of the cesarean delivery scar area. Although only small and often methodologically biased data have been published, they look promising as their results are concordant: ultrasonographic measurements of the LUS thickness is highly correlated with the intraoperative findings at cesarean delivery. Furthermore, the thinner the LUS becomes on ultrasound, the higher the likelihood of a defect in the LUS. Finally, ultrasound assessment of LUS has an excellent negative predictive value for the risk of uterine defect. Therefore, this exam associated with a rule of decision could help to reduce the rate of elective repeat cesarean delivery and especially to reduce the fetal and maternal mortality and morbidity related to trial of labor after a prior cesarean delivery. Methods/design: This is a pragmatic open multicenter randomized trial with two parallel arms. Randomization will be centralized and computerized. Since blindness is impossible, an adjudication committee will evaluate the components of the primary composite outcome in order to avoid evaluation bias. An interim analysis will be planned mid-strength of the trial. Ultrasound will be ... Article in Journal/Newspaper SCAR HAL Sorbonne Université Gynécologie Obstétrique Fertilité & Sénologie 46 4 427 432 |
institution |
Open Polar |
collection |
HAL Sorbonne Université |
op_collection_id |
ftsorbonneuniv |
language |
English |
topic |
Uterine rupture Ultrasound Uterine dehiscence Ultrasonography Cesarean delivery Trial of labor [SDV]Life Sciences [q-bio] |
spellingShingle |
Uterine rupture Ultrasound Uterine dehiscence Ultrasonography Cesarean delivery Trial of labor [SDV]Life Sciences [q-bio] Rozenberg, Patrick Deruelle, Philippe Sénat, Marie Victoire Desbrière, Raoul Winer, Norbert Simon, E. G. Ville, Yves G. Kayem, Gilles Boutron, Isabelle Lower Uterine Segment Trial: A pragmatic open multicenter randomized trial |
topic_facet |
Uterine rupture Ultrasound Uterine dehiscence Ultrasonography Cesarean delivery Trial of labor [SDV]Life Sciences [q-bio] |
description |
International audience Background: The data from literature show that trial of labor and elective repeat cesarean delivery after a prior cesarean delivery both present significant risks and benefits, and these risks and benefits differ for the woman and her fetus. The benefits to the woman can be at the expense of her fetus and vice-versa. This uncertainty is compounded by the scarcity of high-level evidence that preclude accurate quantification of the risks and benefits that could help provide a fair counseling about a trial of labor and elective repeat cesarean delivery. An interesting way of research is to evaluate the potential benefits of a decision rule associated to the ultrasound measurement of the lower uterine segment (LUS). Indeed, ultrasonography may be helpful in determining a specific risk for a given patient by measuring the thickness of the LUS, i,e, the thickness of the cesarean delivery scar area. Although only small and often methodologically biased data have been published, they look promising as their results are concordant: ultrasonographic measurements of the LUS thickness is highly correlated with the intraoperative findings at cesarean delivery. Furthermore, the thinner the LUS becomes on ultrasound, the higher the likelihood of a defect in the LUS. Finally, ultrasound assessment of LUS has an excellent negative predictive value for the risk of uterine defect. Therefore, this exam associated with a rule of decision could help to reduce the rate of elective repeat cesarean delivery and especially to reduce the fetal and maternal mortality and morbidity related to trial of labor after a prior cesarean delivery. Methods/design: This is a pragmatic open multicenter randomized trial with two parallel arms. Randomization will be centralized and computerized. Since blindness is impossible, an adjudication committee will evaluate the components of the primary composite outcome in order to avoid evaluation bias. An interim analysis will be planned mid-strength of the trial. Ultrasound will be ... |
author2 |
Risques cliniques et sécurité en santé des femmes et en santé périnatale (RISCQ) Université de Versailles Saint-Quentin-en-Yvelines (UVSQ) Hôpital Jeanne de Flandre Lille Hôpital Bicêtre Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Bicêtre AP-HP, Le Kremlin-Bicêtre Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP) Hôpital Saint-Joseph Marseille Hôpital Mère Enfant CHU Nantes Hôpital Bretonneau Centre Hospitalier Régional Universitaire de Tours (CHRU Tours) Hôpital Necker - Enfants Malades AP-HP CHU Trousseau APHP Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU) Hôpital Hôtel-Dieu Paris |
format |
Article in Journal/Newspaper |
author |
Rozenberg, Patrick Deruelle, Philippe Sénat, Marie Victoire Desbrière, Raoul Winer, Norbert Simon, E. G. Ville, Yves G. Kayem, Gilles Boutron, Isabelle |
author_facet |
Rozenberg, Patrick Deruelle, Philippe Sénat, Marie Victoire Desbrière, Raoul Winer, Norbert Simon, E. G. Ville, Yves G. Kayem, Gilles Boutron, Isabelle |
author_sort |
Rozenberg, Patrick |
title |
Lower Uterine Segment Trial: A pragmatic open multicenter randomized trial |
title_short |
Lower Uterine Segment Trial: A pragmatic open multicenter randomized trial |
title_full |
Lower Uterine Segment Trial: A pragmatic open multicenter randomized trial |
title_fullStr |
Lower Uterine Segment Trial: A pragmatic open multicenter randomized trial |
title_full_unstemmed |
Lower Uterine Segment Trial: A pragmatic open multicenter randomized trial |
title_sort |
lower uterine segment trial: a pragmatic open multicenter randomized trial |
publisher |
HAL CCSD |
publishDate |
2018 |
url |
https://hal.science/hal-02560874 https://doi.org/10.1016/j.gofs.2018.03.005 |
genre |
SCAR |
genre_facet |
SCAR |
op_source |
ISSN: 2468-7197 EISSN: 2468-7189 Gynécologie Obstétrique Fertilité & Sénologie https://hal.science/hal-02560874 Gynécologie Obstétrique Fertilité & Sénologie, 2018, 46 (4), pp.427-432. ⟨10.1016/j.gofs.2018.03.005⟩ |
op_relation |
info:eu-repo/semantics/altIdentifier/doi/10.1016/j.gofs.2018.03.005 info:eu-repo/semantics/altIdentifier/pmid/29625873 hal-02560874 https://hal.science/hal-02560874 doi:10.1016/j.gofs.2018.03.005 PRODINRA: 485728 PUBMED: 29625873 |
op_doi |
https://doi.org/10.1016/j.gofs.2018.03.005 |
container_title |
Gynécologie Obstétrique Fertilité & Sénologie |
container_volume |
46 |
container_issue |
4 |
container_start_page |
427 |
op_container_end_page |
432 |
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1798854120658960384 |