Uterotonics for management of retained placenta.

IF 8.8 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL
Jen Sothornwit, Chetta Ngamjarus, Porjai Pattanittum, Termtem Waidee, Nampet Jampathong, Apiwat Jongjakapun, Kiattisak Kongwattanakul, Pisake Lumbiganon
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However, evidence regarding uterotonic agents for retained placenta is still limited.</p><p><strong>Objectives: </strong>To assess the benefits and harms of uterotonics for women with retained placenta after vaginal delivery for preventing postpartum haemorrhage.</p><p><strong>Search methods: </strong>We searched CENTRAL, MEDLINE, Embase, CINAHL, ClinicalTrials.gov, and WHO ICTRP; and checked references of included studies and pertinent systematic reviews to identify additional studies. The latest search date was 25 April 2024.</p><p><strong>Eligibility criteria: </strong>We included randomised controlled trials (RCTs) and non-randomised studies of interventions in women who underwent vaginal delivery with retained placenta comparing one uterotonic with another uterotonic, placebo, or no treatment. We excluded studies that compared different uterotonics administered by umbilical vein injection.</p><p><strong>Outcomes: </strong>Our main outcomes were manual removal of the placenta; postpartum haemorrhage of 1000 mL or more; adverse effects, such as shivering; blood transfusion; maternal death; severe morbidity (admission to the intensive care unit); and blood loss in millilitres. The primary time point of interest for all outcomes was the end of the study period.</p><p><strong>Risk of bias: </strong>We used the Cochrane RoB 2 tool to assess bias in RCTs and the ROBINS-I tool to assess bias in non-randomised studies of interventions.</p><p><strong>Synthesis methods: </strong>We synthesised results for each outcome using a random-effects meta-analysis, where possible, employing Mantel-Haenszel with risk ratio (RR) or inverse variance with mean difference (MD), as appropriate. Where this was not possible due to the nature of the data, we synthesised results using narrative synthesis methods. We used GRADE to assess the certainty of evidence for each outcome.</p><p><strong>Included studies: </strong>We included five studies with 560 women, comprising four RCTs and one non-randomised study. The studies were conducted in the Netherlands, Tanzania, and Egypt. Three RCTs compared uterotonics (sulprostone or misoprostol) with placebo or no treatment. One RCT compared oxytocin, intravenous carbetocin, and sublingual misoprostol. One non-randomised study compared intraumbilical oxytocin to oxytocin infusion.</p><p><strong>Synthesis of results: </strong>Systemic uterotonic agents versus placebo or no treatment Sulprostone or misoprostol may result in little to no difference in the rate of manual removal of the placenta (RR 0.82, 95% confidence interval (CI) 0.54 to 1.27; 3 RCTs, 244 women; low-certainty evidence), and probably results in little to no difference in postpartum haemorrhage (RR 0.80, 95% CI 0.55 to 1.15; 2 RCTs, 194 women; moderate-certainty evidence), and blood transfusion (RR 0.72, 95% CI 0.43 to 1.22; 3 RCTs, 244 women; moderate-certainty evidence) compared to placebo or no treatment. We are very uncertain about the effect of misoprostol on shivering (RR 10.00, 95% CI 1.40 to 71.49; 1 RCT, 70 women; very low-certainty evidence) and the effects of uterotonic agents on mean blood loss (MD -205.26 mL, 95% CI -536.31 to 125.79; 3 RCTs, 244 women; very low-certainty evidence). No study assessed maternal death or severe morbidity. Intravenous carbetocin versus sublingual misoprostol Intravenous carbetocin probably does not reduce the need for manual removal of the placenta (RR 0.79, 95% CI 0.52 to 1.20; 1 RCT, 185 women; moderate-certainty evidence), and may not reduce blood transfusion (RR 0.48, 95% CI 0.09 to 2.58; 1 RCT, 185 women; low-certainty evidence) compared to sublingual misoprostol. The study did not assess postpartum haemorrhage of 1000 mL or more, adverse effects (shivering), maternal death, severe morbidity, and blood loss. Sublingual misoprostol versus oxytocin intraumbilical venous injection Sublingual misoprostol probably results in little to no difference in the rate of manual removal of the placenta (RR 1.09, 95% CI 0.73 to 1.61; 1 RCT, 187 women; moderate-certainty evidence) and may not reduce the need for blood transfusion (RR 1.05, 95% CI 0.27 to 4.09; 1 RCT, 187 women; low-certainty evidence) compared to oxytocin intraumbilical venous injection. The study did not assess postpartum haemorrhage of 1000 mL or more, adverse effects (shivering), maternal death, severe morbidity, and blood loss. 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The study did not assess our other outcomes of interest.</p><p><strong>Authors' conclusions: </strong>Current evidence suggests that uterotonic agents (such as misoprostol and sulprostone) may result in little to no difference in the rates of manual removal of the placenta, and probably result in little to no difference in postpartum haemorrhage and the need for blood transfusions, compared to placebo or no treatment in the management of retained placenta. The evidence is very uncertain about their effects on blood loss and the effect of misoprostol on shivering. There is probably little to no difference in effects and there may be no difference in safety between one uterotonic agent over another. We found no useable data for maternal death and admission to the intensive care unit. Further large-scale studies are necessary to evaluate uterotonics versus placebo, compare different uterotonic agents, or assess combined uterotonic regimens. Additional research should focus on identifying specific adverse effects, maternal satisfaction and well-being, breastfeeding rates at discharge, and postpartum anaemia.</p><p><strong>Funding: </strong>This Cochrane review was funded by UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP).</p><p><strong>Registration: </strong>Registration (13 July 2024): Prospero, CRD42024564386.</p>","PeriodicalId":10473,"journal":{"name":"Cochrane Database of Systematic Reviews","volume":"10 ","pages":"CD016147"},"PeriodicalIF":8.8000,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11514361/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cochrane Database of Systematic Reviews","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/14651858.CD016147","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0

Abstract

Rationale: Retained placenta is a significant cause of maternal death from postpartum haemorrhage. Traditionally, it is managed by manual removal under anaesthesia, which carries risks of haemorrhage, infection, and uterine perforation. Uterotonics may offer an alternative for delivering the retained placenta since they induce uterine contractions. However, evidence regarding uterotonic agents for retained placenta is still limited.

Objectives: To assess the benefits and harms of uterotonics for women with retained placenta after vaginal delivery for preventing postpartum haemorrhage.

Search methods: We searched CENTRAL, MEDLINE, Embase, CINAHL, ClinicalTrials.gov, and WHO ICTRP; and checked references of included studies and pertinent systematic reviews to identify additional studies. The latest search date was 25 April 2024.

Eligibility criteria: We included randomised controlled trials (RCTs) and non-randomised studies of interventions in women who underwent vaginal delivery with retained placenta comparing one uterotonic with another uterotonic, placebo, or no treatment. We excluded studies that compared different uterotonics administered by umbilical vein injection.

Outcomes: Our main outcomes were manual removal of the placenta; postpartum haemorrhage of 1000 mL or more; adverse effects, such as shivering; blood transfusion; maternal death; severe morbidity (admission to the intensive care unit); and blood loss in millilitres. The primary time point of interest for all outcomes was the end of the study period.

Risk of bias: We used the Cochrane RoB 2 tool to assess bias in RCTs and the ROBINS-I tool to assess bias in non-randomised studies of interventions.

Synthesis methods: We synthesised results for each outcome using a random-effects meta-analysis, where possible, employing Mantel-Haenszel with risk ratio (RR) or inverse variance with mean difference (MD), as appropriate. Where this was not possible due to the nature of the data, we synthesised results using narrative synthesis methods. We used GRADE to assess the certainty of evidence for each outcome.

Included studies: We included five studies with 560 women, comprising four RCTs and one non-randomised study. The studies were conducted in the Netherlands, Tanzania, and Egypt. Three RCTs compared uterotonics (sulprostone or misoprostol) with placebo or no treatment. One RCT compared oxytocin, intravenous carbetocin, and sublingual misoprostol. One non-randomised study compared intraumbilical oxytocin to oxytocin infusion.

Synthesis of results: Systemic uterotonic agents versus placebo or no treatment Sulprostone or misoprostol may result in little to no difference in the rate of manual removal of the placenta (RR 0.82, 95% confidence interval (CI) 0.54 to 1.27; 3 RCTs, 244 women; low-certainty evidence), and probably results in little to no difference in postpartum haemorrhage (RR 0.80, 95% CI 0.55 to 1.15; 2 RCTs, 194 women; moderate-certainty evidence), and blood transfusion (RR 0.72, 95% CI 0.43 to 1.22; 3 RCTs, 244 women; moderate-certainty evidence) compared to placebo or no treatment. We are very uncertain about the effect of misoprostol on shivering (RR 10.00, 95% CI 1.40 to 71.49; 1 RCT, 70 women; very low-certainty evidence) and the effects of uterotonic agents on mean blood loss (MD -205.26 mL, 95% CI -536.31 to 125.79; 3 RCTs, 244 women; very low-certainty evidence). No study assessed maternal death or severe morbidity. Intravenous carbetocin versus sublingual misoprostol Intravenous carbetocin probably does not reduce the need for manual removal of the placenta (RR 0.79, 95% CI 0.52 to 1.20; 1 RCT, 185 women; moderate-certainty evidence), and may not reduce blood transfusion (RR 0.48, 95% CI 0.09 to 2.58; 1 RCT, 185 women; low-certainty evidence) compared to sublingual misoprostol. The study did not assess postpartum haemorrhage of 1000 mL or more, adverse effects (shivering), maternal death, severe morbidity, and blood loss. Sublingual misoprostol versus oxytocin intraumbilical venous injection Sublingual misoprostol probably results in little to no difference in the rate of manual removal of the placenta (RR 1.09, 95% CI 0.73 to 1.61; 1 RCT, 187 women; moderate-certainty evidence) and may not reduce the need for blood transfusion (RR 1.05, 95% CI 0.27 to 4.09; 1 RCT, 187 women; low-certainty evidence) compared to oxytocin intraumbilical venous injection. The study did not assess postpartum haemorrhage of 1000 mL or more, adverse effects (shivering), maternal death, severe morbidity, and blood loss. Intravenous carbetocin versus oxytocin intraumbilical venous injection Intravenous carbetocin probably does not reduce the rate of manual removal of the placenta (RR 0.86, 95% CI 0.56 to 1.32; 1 RCT, 190 women; moderate-certainty evidence), and may result in little to no difference in reducing blood transfusions (RR 0.51, 95% CI 0.10 to 2.72; 1 RCT, 190 women; low-certainty evidence) compared to intraumbilical venous injection. The study did not assess postpartum haemorrhage of 1000 mL or more, adverse effects (shivering), maternal death, severe morbidity, and blood loss. Oxytocin infusion versus oxytocin intraumbilical venous injection The evidence from one non-randomised study is very uncertain about the effect of oxytocin infusion on manual removal of the placenta compared to oxytocin intraumbilical venous injection (RR 0.90, 95% CI 0.71 to 1.13; 1 study, 35 women; very low-certainty evidence). The study did not assess our other outcomes of interest.

Authors' conclusions: Current evidence suggests that uterotonic agents (such as misoprostol and sulprostone) may result in little to no difference in the rates of manual removal of the placenta, and probably result in little to no difference in postpartum haemorrhage and the need for blood transfusions, compared to placebo or no treatment in the management of retained placenta. The evidence is very uncertain about their effects on blood loss and the effect of misoprostol on shivering. There is probably little to no difference in effects and there may be no difference in safety between one uterotonic agent over another. We found no useable data for maternal death and admission to the intensive care unit. Further large-scale studies are necessary to evaluate uterotonics versus placebo, compare different uterotonic agents, or assess combined uterotonic regimens. Additional research should focus on identifying specific adverse effects, maternal satisfaction and well-being, breastfeeding rates at discharge, and postpartum anaemia.

Funding: This Cochrane review was funded by UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP).

Registration: Registration (13 July 2024): Prospero, CRD42024564386.

用于治疗胎盘滞留的子宫电切术。
理由胎盘滞留是产后大出血导致产妇死亡的一个重要原因。传统的处理方法是在麻醉状态下人工剥离胎盘,这存在大出血、感染和子宫穿孔的风险。子宫收缩剂可诱发子宫收缩,为胎盘滞留的娩出提供了另一种选择。然而,有关子宫收缩剂治疗胎盘滞留的证据仍然有限:目的:评估子宫收缩剂对阴道分娩后胎盘滞留妇女预防产后出血的益处和危害:我们检索了 CENTRAL、MEDLINE、Embase、CINAHL、ClinicalTrials.gov 和 WHO ICTRP;并查阅了纳入研究和相关系统综述的参考文献,以确定其他研究。最新检索日期为 2024 年 4 月 25 日:我们纳入了对胎盘滞留经阴道分娩的妇女进行干预的随机对照试验(RCT)和非随机研究,这些研究对一种子宫收缩剂与另一种子宫收缩剂、安慰剂或无治疗进行了比较。我们排除了对通过脐静脉注射不同子宫收缩剂进行比较的研究:我们的主要结果包括:人工摘除胎盘;产后出血量达到或超过 1000 毫升;不良反应,如颤抖;输血;产妇死亡;严重发病(入住重症监护室);以及失血量(以毫升计)。所有结果的主要关注时间点均为研究期结束时:我们使用 Cochrane RoB 2 工具评估 RCT 的偏倚性,并使用 ROBINS-I 工具评估非随机干预研究的偏倚性:在可能的情况下,我们采用随机效应荟萃分析法对每项结果进行综合分析,并酌情采用曼特尔-海恩泽尔风险比(RR)或反方差与平均差(MD)分析法。如果由于数据的性质而无法采用这种方法,我们则采用叙述性综合方法对结果进行综合。我们使用 GRADE 对每项结果的证据确定性进行评估:我们纳入了 560 名女性的 5 项研究,其中包括 4 项 RCT 研究和 1 项非随机研究。这些研究分别在荷兰、坦桑尼亚和埃及进行。三项研究比较了子宫收缩剂(舒前列酮或米索前列醇)与安慰剂或无治疗方法。一项研究比较了催产素、静脉注射卡贝缩宫素和舌下含服米索前列醇。一项非随机研究对脐内注射催产素和输注催产素进行了比较:系统性子宫收缩剂与安慰剂或不治疗的比较 舒洛普前列酮或米索前列醇可能导致人工胎盘剥离率几乎没有差异(RR 0.82,95% 置信区间(CI)0.54 至 1.0)。与安慰剂或不治疗相比,产后出血(RR 0.80,95% 置信区间 0.55 至 1.15;2 项研究,194 名妇女;中等确定性证据)和输血(RR 0.72,95% 置信区间 0.43 至 1.22;3 项研究,244 名妇女;中等确定性证据)的发生率可能几乎没有差异。关于米索前列醇对颤抖的影响(RR 10.00,95% CI 1.40 至 71.49;1 项 RCT,70 名妇女;极低确定性证据)和子宫收缩剂对平均失血量的影响(MD -205.26 mL,95% CI -536.31 至 125.79;3 项 RCT,244 名妇女;极低确定性证据),我们还很不确定。没有研究对产妇死亡或严重发病情况进行评估。静脉注射卡贝缩宫素与舌下含服米索前列醇 相比舌下含服米索前列醇,静脉注射卡贝缩宫素可能不会减少人工剥离胎盘的需要(RR 0.79,95% CI 0.52 至 1.20;1 项 RCT,185 名妇女;中等确定性证据),也可能不会减少输血(RR 0.48,95% CI 0.09 至 2.58;1 项 RCT,185 名妇女;低确定性证据)。该研究未对产后出血量达到或超过 1000 毫升、不良反应(颤抖)、产妇死亡、严重发病率和失血量进行评估。舌下含服米索前列醇与脐静脉注射催产素相比 舌下含服米索前列醇与脐静脉注射催产素相比,人工剥离胎盘的比率可能几乎没有差异(RR 1.09,95% CI 0.73 至 1.61;1 项 RCT,187 名产妇;中度确定性证据),也可能不会减少输血需求(RR 1.05,95% CI 0.27 至 4.09;1 项 RCT,187 名产妇;低度确定性证据)。该研究未对产后出血量达到或超过 1000 毫升、不良反应(颤抖)、产妇死亡、严重发病率和失血量进行评估。静脉注射卡贝缩宫素与脐静脉注射催产素相比 静脉注射卡贝缩宫素可能不会降低人工移除胎盘的比率(RR 0.86,95% CI 0.56 至 1.32;1 项 RCT,190 名产妇;中度确定性证据),而且与脐静脉注射相比,在减少输血方面可能几乎没有差别(RR 0.51,95% CI 0.10 至 2.72;1 项 RCT,190 名产妇;低度确定性证据)。
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来源期刊
CiteScore
10.60
自引率
2.40%
发文量
173
审稿时长
1-2 weeks
期刊介绍: The Cochrane Database of Systematic Reviews (CDSR) stands as the premier database for systematic reviews in healthcare. It comprises Cochrane Reviews, along with protocols for these reviews, editorials, and supplements. Owned and operated by Cochrane, a worldwide independent network of healthcare stakeholders, the CDSR (ISSN 1469-493X) encompasses a broad spectrum of health-related topics, including health services.
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