Chitosan-covered tamponade for the treatment of postpartum hemorrhage: a registry-based cohort study assessing outcomes and risk factors for treatment failure.

IF 2.7 2区 医学 Q1 OBSTETRICS & GYNECOLOGY BMC Pregnancy and Childbirth Pub Date : 2025-02-05 DOI:10.1186/s12884-025-07236-5
Clara Leichtle, Annette Aigner, Carolin Biele, Paulina Hermann, Teresa Dangli, Charlotte Waldner, Thorsten Braun, Wolfgang Henrich, Anna Maria Dückelmann
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Abstract

Background: Postpartum hemorrhage (PPH) is one of the leading causes of maternal morbidity and mortality worldwide. Intrauterine hemostatic devices are recommended when PPH does not respond to medical treatment. The objective of this study was to assess the factors leading to unsuccessful intrauterine therapy with a chitosan-covered tamponade (CT) for the treatment of PPH and to evaluate clinical outcomes based on real-world data.

Methods: This registry-based cohort study included all women treated with CT for PPH between January 2017 and June 2022 at a university clinic's perinatal department. The endpoint was defined as the failure of CT, indicated by the requirement of further invasive procedures for ongoing hemorrhage after CT application. Medical records were reviewed and binary logistic regressions used to evaluate delivery mode, placenta previa, and placenta accreta spectrum as potential risk factors for CT treatment failure.

Results: The cohort consisted of 230 women, with successful CT treatment in 91.3%. The success rate for mild PPH was 100.0%, for moderate 95.5%, and for severe 84.2%. Five hysterectomies were performed in total. Placenta previa in cesarean sections was identified as the primary risk factor for CT treatment failure, increasing the odds about 7.5-fold (Odds Ratio: 7.48; 95% CI: 1.87-33.15) compared to cesarean sections without placenta previa. Furthermore, delays in CT insertion may also contribute to treatment failure.

Conclusion: CT serves as an intrauterine treatment for medically intractable PPH. Placenta previa significantly increases the risk of CT treatment failure in cesarean sections. Obstetricians should be particularly vigilant in managing patients with placenta previa and consider early use of CT or a combination of procedures.

Trial registration: This study was approved by the local Ethics Committee on 11/10/2021 (EA4/231/21).

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壳聚糖包覆填塞治疗产后出血:一项基于登记的队列研究,评估治疗失败的结果和危险因素。
背景:产后出血(PPH)是全世界孕产妇发病和死亡的主要原因之一。当PPH对药物治疗无效时,建议使用宫内止血装置。本研究的目的是评估导致壳聚糖包覆填塞(CT)治疗PPH宫内治疗失败的因素,并根据实际数据评估临床结果。方法:这项基于登记的队列研究纳入了2017年1月至2022年6月在一所大学诊所围产期接受过PPH CT治疗的所有女性。终点被定义为CT失败,通过CT应用后持续出血需要进一步的侵入性手术来指示。我们回顾了医疗记录,并使用二元logistic回归来评估分娩方式、前置胎盘和胎盘增生谱作为CT治疗失败的潜在危险因素。结果:该队列包括230名女性,91.3%的女性CT治疗成功。轻度PPH的成功率为100.0%,中度为95.5%,重度为84.2%。共行5例子宫切除术。剖宫产前置胎盘被确定为CT治疗失败的主要危险因素,增加了约7.5倍(优势比:7.48;95% CI: 1.87-33.15)与无前置胎盘剖宫产相比。此外,CT插入的延迟也可能导致治疗失败。结论:CT可作为难治性PPH的宫内治疗手段。前置胎盘显著增加剖宫产术CT治疗失败的风险。产科医生在处理前置胎盘患者时应特别警惕,并考虑早期使用CT或综合检查。试验注册:本研究已于11/10/2021 (EA4/231/21)获得当地伦理委员会批准。
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来源期刊
BMC Pregnancy and Childbirth
BMC Pregnancy and Childbirth OBSTETRICS & GYNECOLOGY-
CiteScore
4.90
自引率
6.50%
发文量
845
审稿时长
3-8 weeks
期刊介绍: BMC Pregnancy & Childbirth is an open access, peer-reviewed journal that considers articles on all aspects of pregnancy and childbirth. The journal welcomes submissions on the biomedical aspects of pregnancy, breastfeeding, labor, maternal health, maternity care, trends and sociological aspects of pregnancy and childbirth.
期刊最新文献
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