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中华妇幼临床医学杂志(电子版)

Chinese Journal of Obstetrics & Gynecology and Pediatrics(Electronic Edition) ›› 2019, Vol. 15 ›› Issue (03): 253 -261. doi: 10.3877/cma.j.issn.1673-5250.2019.03.004

Special Issue: ； ；

Original Article

Efficacy and safety of cervical pessaries for preventing preterm birth in twin pregnancy: a systematic review

Tingting Xu1, Zhiyi Zhou1, Na Liu1, Chunyan Deng1, Guiqiong Huang1, Xiaodong Wang1, Haiyan Yu1,†()   

  1. 1. Department of Obstetrics and Gynecology, Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, West China Second University Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China
  • Received:2018-12-18 Revised:2019-05-08 Published:2019-06-01
  • Corresponding author: Haiyan Yu
  • About author:
    Corresponding author: Yu Haiyan, Email:
  • Supported by:
    Key Research and Development Project of Science and Technology Department of Sichuan Province(2018FZ0041); Project of Academic and Technical Leader Training in Sichuan Province([2017]919-25)
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Objective

To evaluate the efficacy and safety of cervical pessaries in the prevention of preterm birth in twin pregnancy with short cervical length (CL).

Methods

Based on the principles and methods of Cochrane systematic reviews, we searched the Embase, PubMed, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Ovid-Medline, American College of Physicians (ACP), China Biology Medicine (CBM), China National Knowledge Infrastructure (CNKI), VIP, and Wanfang databases for randomized controlled trial (RCT) to evaluate efficacy and safety of cervical pessaries in the prevention of preterm birth in twin pregnancy with short CL from the date of database inception to January 2018. Related conference papers and dissertations were also searched manually. The methodological quality and data extraction of the included studies were assessed independently by two reviewers followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), and Meta-analysis was conducted using RevMan 5.0 software. The heterogeneity of the treatment was evaluated with the I2 statistic. RR value and its 95%CI were computed for dichotomous data and were combined with a fixed-effects model (I2<50%) using the Mantel-Haenszel method. A random-effects model was used to analyze the results (with values of I2>50%).

Results

Five RCTs, involving 2 465 twin pregnancies and 827 of them combined with short CL that pertained to pessary use, met the inclusion criteria. Treatment with a pessary was associated with a significant reduction in the rate of admission to the neonatal intensive care unit (NICU) (RR=0.73, 95%CI: 0.53-1.00, P=0.05). There were higher incidences of vaginal discharge (RR=3.07, 95%CI: 1.29-7.30, P=0.01) and retinopathy of prematurity(ROP) (RR=3.85, 95%CI: 1.19-12.45, P=0.02) in cervical pessary group. No significant differences were found between pessary group and control group among other major maternal and neonatal outcomes. A subgroup analysis of twin pregnancies associated with short CL by different CL values (CL≤ 25 mm or <38 mm) was conducted. Treatment with a pessary was associated with a significant reduction in the rate of preterm birth< 37 gestational weeks (RR=0.81, 95%CI: 0.69-0.94, P=0.007), neonatal sepsis (RR=0.50, 95%CI: 0.30-0.86, P=0.01) and neonatal necrotising enterocolitis (RR=0.43, 95%CI: 0.20-0.95, P=0.04) in twin pregnancy with CL<38 mm. In twin pregnancy with CL ≤25 mm, no significant difference was found between pessary group and control group among major maternal and neonatal outcomes.

Conclusions

These results suggest that cervical pessary in the twin pregnancy is not likely to facilitate the prevention of PTB, but can significantly reduce the rate of NICU. It seems that cervical pessary has much more protective efficacy in twin pregnancy with a cervical length <38 mm.

Key words: Pessaries, Cervix uteri, Pregnancy trimester, second, Twin pregnancy, Cervical length measurement, Systematic review, Pregnancy outcome, Pregnant women
图1 文献筛选流程图
表1 纳入文献基本特征
第一作者，文献发表年 子宫颈托类型 纳入/排除标准 子宫颈托组 对照组 主要/次要指标 不良反应（子宫颈托vs对照组） 随访率[%（n/n’）]
所有双胎妊娠孕妇/对应胎儿样本量 双胎妊娠合并宫颈缩短/对应胎儿样本量 所有双胎妊娠孕妇/对应胎儿样本量 双胎妊娠合并宫颈缩短/对应胎儿样本量
Goya, 2016[13] Arabin ①纳入标准：孕龄为18~22孕周，双胎妊娠合并CL≤25 mm并且无明显临床症状；②排除标准：胎儿先天性异常，规律宫缩，引导活动性出血，前置胎盘，PPROM，宫颈活组织检查或者宫颈环扎史 68/136 68/136 66/130a 66/130a ①主要指标：早产儿出生胎龄<34周；②次要指标：新生儿出生体重、死亡，胎儿宫内死亡，孕妇阴道排液、引导感染等 阴道排液：100% vs 53%，阴道流血：4.4% vs 4.5%；子宫颈托重置：16.2% vs 0，子宫颈托替换：2.9% vs 0 97.8（134/137）
Berghella, 2017[15] Bioteque ①纳入标准：孕龄为18~27+6孕周，双胎妊娠合并CL≤30 mm并且无明显临床症状；②排除标准：双胎，TTTS，sIUGR，前置胎盘 23/46 23/46 23/46 23/46 ①主要指标：早产儿出生胎龄<34周；②次要指标：早产儿胎龄<37周、<32周、<28周或者<24周，发生SPB时胎龄<37周、<34周、<28周或者<24周，早产儿分娩孕周、出生体重，孕妇绒毛膜羊膜炎，泌尿生殖系统感染，剖宫产分娩 阴道排液：83% vs 43% 100.0（46/46）
Liem, 2013[16] Arabin ①纳入标准：孕龄为16~20孕周，双胎妊娠合并CL<38 mm；②排除标准：胎儿具有严重先天畸形，胎儿死亡，TTTS，前置胎盘 401/802 78/156 407/814 55/110 ①主要指标：死胎、新生儿脑白质软化、重度RDS、IVH、NEC、BPD、脓毒症、新生儿死亡；②次要指标：早产儿出生胎龄<32周或者<37周、NICU治疗、住院天数、产妇死亡率 阴道排液：26% vs 0，疼痛：4% vs <1%，阴道排液伴疼痛：3% vs 0，发热或感染：2% vs 1% 99.4（808/813）
Nicolaides, 2016[17] Arabin ①纳入标准：孕龄为20+1~24+6孕周，双胎妊娠合并CL<25 mm并且无明显临床症状；②排除标准：孕妇年龄<16岁，胎儿死亡，胎儿严重先天畸形，TTTS，sIUGR，宫颈环扎，规律宫缩，既往PROM史 588/1 176 106/212 589/1 178 108/216 ①主要指标：发生SPB时胎龄<34周②次要指标：早产儿围生期死亡、脑室出血、RDS、ROP、NEC、NICU治疗治疗等 阴道排液：10.9% vs 10.2%，盆腔不适：1.2% vs 1.5% 99.7（1 177/1 180）
Dang, 2018[23] Arabin ①纳入标准：孕龄为16~22孕周，双胎妊娠合并CL<38 mm并且无明显临床症状；②排除标准：既往宫颈锥切或者宫颈环扎史，早产史，TTTS，死胎或胎儿先天畸形，急性阴道炎，PROM 150/300 150/300 15/300 150/300 ①主要指标：早产儿出生胎龄<34周；②次要指标：早产出生胎龄<37周或者<28周、新生儿出生体重、围生期胎儿/新生儿死亡、NICU治疗、RDS、IVH、NEC、败血症，孕妇分娩孕龄、阴道流液 阴道排液：69.3% vs 24% 100.0（300/300）
图2 文献的偏倚风险评估(图2A：纳入试验的偏倚风险分析图；图2B纳入试验的偏倚风险总结)
表2 双胎妊娠的妊娠结局评价
妊娠结局 RCT数量(篇) 双胎孕妇例数/分娩新生儿例数 统计学异质性 Meta分析结果
子宫颈托组 对照组 χ2值 P值 I2(%) RR值(95%CI) P值
双胎孕妇 ? ? ? ? ? ? ? ?
? 分娩时孕龄<37孕周 3 314/574 343/580 2.63 0.27 24 0.92(0.84～1.02) 0.13
? 分娩时孕龄<34孕周 4 143/829 160/828 8.72 0.03 66 0.80(0.53～1.21) 0.28
? 分娩时孕龄<32孕周 2 93/989 102/996 0.29 0.59 0 0.92(0.70～1.20) 0.53
? 分娩时孕龄<28孕周 4 48/1 162 47/1 169 1.36 0.71 0 1.03(0.69～1.52) 0.89
? SPB时孕龄<37孕周 2 59/91 60/89 0.03 0.86 0 0.96(0.78～1.18) 0.70
? SPB时孕龄<34孕周 3 98/679 109/678 7.37 0.03 73 0.77(0.41～1.44) 0.41
? SPB时胎龄<28孕周 2 8/91 13/89 0.96 0.33 0 0.60(0.26～1.38) 0.23
? PPROM 3 40/492 46/496 3.32 0.19 40 0.88(0.59～1.31) 0.53
? 阴道排液 4 295/642 81/646 47.89 <0.001 94 3.07(1.29～7.30) 0.01
? 剖宫产术分娩 3 251/492 224/496 2.74 0.25 27 1.13(0.99～1.29) 0.06
? 绒毛膜羊膜炎 2 15/469 16/473 0 0.98 0 0.95(0.47～1.89) 0.88
胎儿/新生儿 ? ? ? ? ? ? ? ?
? 新生儿败血症 5 111/2 420 132/2 430 5.84 0.21 32 0.84(0.66～1.08) 0.18
? RDS 5 196/2 420 196/2 430 6.50 0.16 38 1.00(0.83～1.21) 0.97
? IVH 5 31/2 420 29/2 430 2.97 0.56 0 1.07(0.65～1.76) 0.79
? 糖皮质激素促胎肺成熟 2 119/469 144/473 0.10 0.75 0 0.83(0.68～1.02) 0.08
? NEC 5 25/2 420 33/2 430 4.82 0.31 17 0.77(0.47～1.28) 0.31
? 出生体重<2 500 g 4 1 296/2 423 1 397/2 431 10.69 0.01 72 0.90(0.80～1.01) 0.07
? 出生体重<1 500 g 3 195/2 123 199/2 131 0.93 0.63 0 0.98(0.81～1.19) 0.86
? 宫缩药物应用 2 96/469 121/473 0.15 0.69 0 0.80(0.63～1.01) 0.06
? ROP 3 131/1 329 3/1 322 0.03 0.87 0 3.85(1.19～12.45) 0.02
? BPD 2 6/857 14/869 1.63 0.20 39 0.43(0.17～1.10) 0.08
? NICU 2 141/1 091 190/1 108 2.19 0.14 54 0.73(0.53～1.00) 0.05
? 胎儿死亡 3 22/2 123 34/2 131 0.70 0.71 0 0.66(0.39～1.11) 0.12
? 新生儿死亡 3 21/1 358 17/1 354 0.01 0.91 0 1.24(0.66～2.33) 0.51
? 围生期胎儿/新生儿死亡 3 50/1 612 51/1 608 1.75 0.42 0 0.98(0.67～1.43) 0.92
表3 双胎妊娠合并宫颈长度缩短的亚组妊娠结局分析
项目 RCT数量(篇) 双胎孕妇例数/分娩新生儿例数 统计学异质性 Meta分析结果
子宫颈托组 对照组 χ2值 P值 I2(%) RR值(95%CI) P值
CL<38 mm双胎孕妇 ? ? ? ? ? ? ? ?
? 早产儿出生胎龄<37周 2 123/228 134/205 0.02 0.88 0 0.81(0.69～0.94) 0.007
? 早产儿出生胎龄<28周 2 12/228 16/205 4.43 0.04 77 0.58(0.11～3.06) 0.52
? 新生儿败血症 2 19/437 37/396 0.19 0.66 0 0.50(0.30～0.86) 0.01
? RDS 2 41/437 55/396 2.15 0.14 53 0.85(0.37～1.97) 0.71
? IVH 2 3/437 6/396 3.11 0.08 68 0.43(0.02～8.47) 0.58
? NEC 2 8/437 19/396 0.15 0.70 0 0.43(0.20～0.95) 0.04
CL≤25 mm双胎孕妇 ? ? ? ? ? ? ? ?
? SPB时孕龄<37周 2 102/174 98/174 0.93 0.34 0 1.04(0.87～1.24) 0.69
? SPB时孕龄<34周 2 44/174 54/174 7.89 0.005 87 0.72(0.25～2.06) 0.54
? SPB时孕龄<28周 2 18/174 17/174 3.96 0.05 75 0.93(0.23～3.71) 0.91
? 出生体重<2 500 g 2 196/348 212/346 4.65 0.03 78 0.88(0.63～1.23) 0.45
? 出生体重<1 500 g 2 58/348 53/346 1.91 0.17 48 1.10(0.78～1.54) 0.60
? 围生儿死亡 2 20/348 14/346 1.93 0.16 48 1.43(0.75～2.74) 0.28
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