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Anesthetic management of cesarean section in cases of placenta accreta, with versus without abdominal aortic balloon occlusion: study protocol for a randomized controlled trial

BACKGROUND: Placenta accreta (PA), a severe complication during delivery, is closely linked with massive hemorrhage which could endanger the lives of both mother and baby. Moreover, the incidence of PA has increased dramatically with the increasing rate of cesarean deliveries in the past few decades...

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Autores principales: Chu, Qinjun, Shen, Dan, He, Long, Wang, Hongwei, Zhao, Xianlan, Chen, Zhimin, Wang, Yanli, Zhang, Wei
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5446702/
https://www.ncbi.nlm.nih.gov/pubmed/28549439
http://dx.doi.org/10.1186/s13063-017-1977-5
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author Chu, Qinjun
Shen, Dan
He, Long
Wang, Hongwei
Zhao, Xianlan
Chen, Zhimin
Wang, Yanli
Zhang, Wei
author_facet Chu, Qinjun
Shen, Dan
He, Long
Wang, Hongwei
Zhao, Xianlan
Chen, Zhimin
Wang, Yanli
Zhang, Wei
author_sort Chu, Qinjun
collection PubMed
description BACKGROUND: Placenta accreta (PA), a severe complication during delivery, is closely linked with massive hemorrhage which could endanger the lives of both mother and baby. Moreover, the incidence of PA has increased dramatically with the increasing rate of cesarean deliveries in the past few decades. Therefore, studies evaluating the effects of different perioperative managements based on different modalities in the treatment of PA are necessary. Among the numerous treatment measures, prophylactic abdominal aortic balloon occlusion (AABO) in combination with cesarean section for PA seems to be more advantageous than others. However, up to now, all studies on AABO were almost retrospective. Current evidence is insufficient to recommend for or against routinely using the AABO technology for control intraoperative hemorrhage in patients with PA. Thus, we hope to carry out a prospective, randomized controlled trial (RCT) study to confirm the effectiveness of the AABO technology in patients with PA. METHODS/DESIGN: This trial is an investigator-initiated, prospective RCT that will test the superiority of AABO in combination with cesarean section compared to the traditional hysterectomy following cesarean section for parturients with PA. A total of 170 parturients with PA undergoing cesarean section will be randomized to receive either AABO in combination with cesarean section or the traditional hysterectomy following cesarean section. The primary outcome is estimated blood loss. The most important secondary outcome is the occurrence of cesarean hysterectomy during delivery; others include blood transfusion volume, operating time, neonate’s Apgar scores (collected at 1, 5 and 10 min), length of stay in intensive care unit, total hospital stay, and balloon occlusion-relative data. DISCUSSION: This prospective trial will test the superiority of AABO in combination with cesarean section compared to the traditional hysterectomy following cesarean section for parturients with PA. It may provide strong evidence about the benefits and risks of AABO in combination with cesarean section for parturients with PA. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-INR-16008842. Registered on 14 July 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-1977-5) contains supplementary material, which is available to authorized users.
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spelling pubmed-54467022017-05-30 Anesthetic management of cesarean section in cases of placenta accreta, with versus without abdominal aortic balloon occlusion: study protocol for a randomized controlled trial Chu, Qinjun Shen, Dan He, Long Wang, Hongwei Zhao, Xianlan Chen, Zhimin Wang, Yanli Zhang, Wei Trials Study Protocol BACKGROUND: Placenta accreta (PA), a severe complication during delivery, is closely linked with massive hemorrhage which could endanger the lives of both mother and baby. Moreover, the incidence of PA has increased dramatically with the increasing rate of cesarean deliveries in the past few decades. Therefore, studies evaluating the effects of different perioperative managements based on different modalities in the treatment of PA are necessary. Among the numerous treatment measures, prophylactic abdominal aortic balloon occlusion (AABO) in combination with cesarean section for PA seems to be more advantageous than others. However, up to now, all studies on AABO were almost retrospective. Current evidence is insufficient to recommend for or against routinely using the AABO technology for control intraoperative hemorrhage in patients with PA. Thus, we hope to carry out a prospective, randomized controlled trial (RCT) study to confirm the effectiveness of the AABO technology in patients with PA. METHODS/DESIGN: This trial is an investigator-initiated, prospective RCT that will test the superiority of AABO in combination with cesarean section compared to the traditional hysterectomy following cesarean section for parturients with PA. A total of 170 parturients with PA undergoing cesarean section will be randomized to receive either AABO in combination with cesarean section or the traditional hysterectomy following cesarean section. The primary outcome is estimated blood loss. The most important secondary outcome is the occurrence of cesarean hysterectomy during delivery; others include blood transfusion volume, operating time, neonate’s Apgar scores (collected at 1, 5 and 10 min), length of stay in intensive care unit, total hospital stay, and balloon occlusion-relative data. DISCUSSION: This prospective trial will test the superiority of AABO in combination with cesarean section compared to the traditional hysterectomy following cesarean section for parturients with PA. It may provide strong evidence about the benefits and risks of AABO in combination with cesarean section for parturients with PA. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-INR-16008842. Registered on 14 July 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-1977-5) contains supplementary material, which is available to authorized users. BioMed Central 2017-05-26 /pmc/articles/PMC5446702/ /pubmed/28549439 http://dx.doi.org/10.1186/s13063-017-1977-5 Text en © The Author(s). 2017 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. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Chu, Qinjun
Shen, Dan
He, Long
Wang, Hongwei
Zhao, Xianlan
Chen, Zhimin
Wang, Yanli
Zhang, Wei
Anesthetic management of cesarean section in cases of placenta accreta, with versus without abdominal aortic balloon occlusion: study protocol for a randomized controlled trial
title Anesthetic management of cesarean section in cases of placenta accreta, with versus without abdominal aortic balloon occlusion: study protocol for a randomized controlled trial
title_full Anesthetic management of cesarean section in cases of placenta accreta, with versus without abdominal aortic balloon occlusion: study protocol for a randomized controlled trial
title_fullStr Anesthetic management of cesarean section in cases of placenta accreta, with versus without abdominal aortic balloon occlusion: study protocol for a randomized controlled trial
title_full_unstemmed Anesthetic management of cesarean section in cases of placenta accreta, with versus without abdominal aortic balloon occlusion: study protocol for a randomized controlled trial
title_short Anesthetic management of cesarean section in cases of placenta accreta, with versus without abdominal aortic balloon occlusion: study protocol for a randomized controlled trial
title_sort anesthetic management of cesarean section in cases of placenta accreta, with versus without abdominal aortic balloon occlusion: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5446702/
https://www.ncbi.nlm.nih.gov/pubmed/28549439
http://dx.doi.org/10.1186/s13063-017-1977-5
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