Abdel-Aleem Hany, Shaaban Omar M, Abdel-Aleem Mahmoud A
Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University Hospital, Assiut, Egypt.
Cochrane Database Syst Rev. 2013 May 31;2013(5):CD007873. doi: 10.1002/14651858.CD007873.pub3.
Preterm birth is a major health problem and contributes to more than 50% of the overall perinatal mortality. Preterm birth has multiple risk factors including cervical incompetence and multiple pregnancy. Different management strategies have been tried to prevent preterm birth, including cervical cerclage. Cervical cerclage is an invasive technique that needs anaesthesia and may be associated with complications. Moreover, there is still controversy regarding the efficacy and the group of patients that could benefit from this operation. Cervical pessary has been tried as a simple, non-invasive alternative that might replace the above invasive cervical stitch operation to prevent preterm birth.
To evaluate the efficacy of cervical pessary for the prevention of preterm birth in women with risk factors for cervical incompetence.
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 September 2012), Current Controlled Trials and the Australian New Zealand Clinical Trials Registry (1 September 2012).
We selected all published and unpublished randomised clinical trials comparing the use of cervical pessary with cervical cerclage or expectant management for prevention of preterm birth. We did not include quasi-randomised trials. Cluster-randomised or cross-over trials were not eligible for inclusion.
Two review authors independently assessed trials for inclusion.
The review included one randomised controlled trial. The study included 385 pregnant women with a short cervix of 25 mm or less who were between 18 to 22 weeks of pregnancy. The use of cervical pessary (192 women) was associated with a statistically significantly decrease in the incidence of spontaneous preterm birth less than 37 weeks' gestation compared with expectant management (22% versus 59 %; respectively, risk ratio (RR) 0.36, 95% confidence interval (CI) 0.27 to 0.49). Spontaneous preterm birth before 34 weeks was statistically significantly reduced in the pessary group (6% and 27% respectively, RR 0.24; 95% CI 0.13 to 0.43). Mean gestational age at delivery was 37.7 + 2 weeks in the pessary group and 34.9 + 4 weeks in the expectant group. Women in the pessary group used less tocolytics (RR 0.63; 95% CI 0.50 to 0.81) and corticosteroids (RR 0.66; 95% CI 0.54 to 0.81) than the expectant group. Vaginal discharge was more common in the pessary group (RR 2.18; 95% CI 1.87 to 2.54). Among the pessary group, 27 women needed pessary repositioning without removal and there was one case of pessary removal. Ninety-five per cent of women in the pessary group would recommend this intervention to other people. Neonatal paediatric care admission was reduced in the pessary group in comparison to the expectant group (RR 0.17; 95% CI 0.07 to 0.42).
AUTHORS' CONCLUSIONS: The review included only one well-designed randomised clinical trial that showed beneficial effect of cervical pessary in reducing preterm birth in women with a short cervix. There is a need for more trials in different settings (developed and developing countries), and with different risk factors including multiple pregnancy.
早产是一个主要的健康问题,占围产期总死亡率的50%以上。早产有多种风险因素,包括宫颈机能不全和多胎妊娠。人们尝试了不同的管理策略来预防早产,包括宫颈环扎术。宫颈环扎术是一种侵入性技术,需要麻醉,且可能伴有并发症。此外,关于其疗效以及可能从该手术中获益的患者群体仍存在争议。宫颈托已被尝试作为一种简单、非侵入性的替代方法,可能会取代上述侵入性宫颈缝合手术来预防早产。
评估宫颈托对预防有宫颈机能不全风险因素的女性早产的疗效。
我们检索了Cochrane妊娠与分娩组试验注册库(2012年9月1日)、当前对照试验以及澳大利亚和新西兰临床试验注册库(2012年9月1日)。
我们选择了所有已发表和未发表的随机临床试验,这些试验比较了使用宫颈托与宫颈环扎术或期待治疗预防早产的效果。我们未纳入半随机试验。整群随机试验或交叉试验不符合纳入标准。
两位综述作者独立评估试验是否纳入。
该综述纳入了一项随机对照试验。该研究纳入了385名妊娠18至22周、宫颈短(25毫米或更短)的孕妇。与期待治疗相比,使用宫颈托(192名女性)与妊娠37周前自发性早产发生率的统计学显著降低相关(分别为22%和59%;风险比(RR)0.36,95%置信区间(CI)0.27至0.49)。宫颈托组34周前的自发性早产在统计学上显著降低(分别为6%和27%,RR 0.24;95% CI 0.13至0.43)。宫颈托组的平均分娩孕周为37.7±2周,期待组为34.9±4周。宫颈托组的女性使用宫缩抑制剂(RR 0.63;95% CI 0.50至0.81)和皮质类固醇(RR 0.66;95% CI 0.54至0.81)的次数少于期待组。宫颈托组阴道分泌物更常见(RR 2.18;95% CI 1.87至2.54)。在宫颈托组中,27名女性需要在不移除的情况下重新放置宫颈托,有1例宫颈托移除。宫颈托组中95%的女性会向其他人推荐这种干预措施。与期待组相比,宫颈托组新生儿儿科护理入院率降低(RR 0.17;95% CI 0.07至0.42)。
该综述仅纳入了一项设计良好的随机临床试验,该试验表明宫颈托对减少宫颈短的女性早产有有益效果。需要在不同环境(发达国家和发展中国家)以及具有不同风险因素(包括多胎妊娠)的情况下进行更多试验。