Pingray V, Widmer M, Ciapponi A, Hofmeyr G J, Deneux C, Gülmezoglu M, Bloemenkamp K, Oladapo O T, Comandé D, Bardach A, Vázquez P, Cormick G, Althabe F
Instituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Buenos Aires, Argentina.
UNDP-UNFPA-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction (HRP), Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
BJOG. 2021 Oct;128(11):1732-1743. doi: 10.1111/1471-0528.16819. Epub 2021 Jul 19.
To evaluate uterine tamponade devices' effectiveness for atonic refractory postpartum haemorrhage (PPH) after vaginal birth and the effect of including them in institutional protocols.
PubMed, EMBASE, CINAHL, LILACS, POPLINE, from inception to January 2021.
Randomised and non-randomised comparative studies.
Composite outcome including surgical interventions (artery ligations, compressive sutures or hysterectomy) or maternal death, and hysterectomy.
All included studies were at high risk of bias. The certainty of the evidence was rated as very low to low. One randomised study measured the effect of the condom-catheter balloon compared with standard care and found unclear results for the composite outcome (relative risk [RR] 2.33, 95% CI 0.76-7.14) and hysterectomy (RR 4.14, 95% CI 0.48-35.93). Three comparative studies assessed the effect of including uterine balloon tamponade in institutional protocols. A stepped wedge cluster randomised controlled trial suggested an increase in the composite outcome (RR 4.08, 95% CI 1.07-15.58) and unclear results for hysterectomy (RR 4.38, 95% CI 0.47-41.09) with the use of the condom-catheter or surgical glove balloon. One non-randomised study showed unclear effects on the composite outcome (RR 0.33, 95% CI 0.11-1.03) and hysterectomy (RR 0.49, 95% CI 0.04-5.38) after the inclusion of the Bakri balloon. The second non-randomised study found unclear effects on the composite outcome (RR 0.95, 95% CI 0.32-2.81) and hysterectomy (RR 1.84, 95% CI 0.44-7.69) after the inclusion of Ebb or Bakri balloon.
The effect of uterine tamponade devices for the management of atonic refractory PPH after vaginal delivery is unclear, as is the role of the type of device and the setting.
Unclear effects of uterine tamponade devices and their inclusion in institutional protocols for atonic refractory PPH after vaginal delivery.
评估子宫压迫装置对阴道分娩后难治性宫缩乏力性产后出血（PPH）的有效性以及将其纳入机构方案的效果。
检索PubMed、EMBASE、CINAHL、LILACS、POPLINE，检索时间从数据库建库至2021年1月。
随机和非随机对照研究。
综合结局指标包括手术干预（动脉结扎、压迫缝合或子宫切除术）或孕产妇死亡，以及子宫切除术。
所有纳入研究均存在高偏倚风险。证据确定性被评为极低到低。一项随机研究比较了避孕套导管球囊与标准治疗的效果，发现综合结局指标（相对危险度[RR]2.33，95%可信区间[CI]0.76 - 7.14）和子宫切除术（RR 4.14，95%CI 0.48 - 35.93）的结果不明确。三项比较研究评估了将子宫球囊压迫纳入机构方案的效果。一项阶梯楔形整群随机对照试验表明，使用避孕套导管或手术手套球囊后，综合结局指标增加（RR 4.08，95%CI 1.07 - 15.58），子宫切除术结果不明确（RR 4.38，95%CI 0.47 - 41.09）。一项非随机研究显示，纳入Bakri球囊后，综合结局指标（RR 0.33，95%CI 0.11 - 1.03）和子宫切除术（RR 0.49，95%CI 0.04 - 5.3）的效果不明确。第二项非随机研究发现，纳入Ebb或Bakri球囊后，综合结局指标（RR 0.95，95%CI 0.32 - 2.81）和子宫切除术（RR 1.84，95%CI 0.44 - 7.69）的效果不明确。
子宫压迫装置对阴道分娩后难治性宫缩乏力性PPH的治疗效果不明确，装置类型和应用场景的作用也不明确。
子宫压迫装置及其纳入阴道分娩后难治性宫缩乏力性PPH机构方案的效果不明确。
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