子宫颈子宫托无法减少早期早产风险


  【24drs.com】一篇多中心随机控制试验显示,相较于期待性处理法,子宫颈子宫托无法减少短子宫颈之妇女的自发性早期早产风险比率。
  
  英国伦敦国王学院Harris胎儿医学生产权研究中心Kypros H. Nicolaides医师等人在3月17日的新英格兰医学期刊发表他们的研究结果。
  
  子宫颈子宫托是放置在子宫颈阴道周围、矽氧树脂材质的一种器具,它可以支撑子宫颈、让子宫颈朝向骶骨,而减少子宫对子宫颈管的直接压力。
  
  该试验的研究对象是,怀有单胞胎的16岁以上女性、在妊娠20周0天至24周6天这段期间进行例行性超音波检查,子宫颈长度为25 mm以下者;在研究期间的任何时间点,子宫颈长度15 mm以下者,给予阴道黄体素治疗。
  
  研究者随机指定466名研究对象到子宫颈子宫托组,469名到期待性处理法这组。
  
  该研究的初级终点是妊娠34周前自发性生产,子宫托组有55人(12.0%)发生,对照组则是有50人(10.8%)发生(子宫托组胜算比[OR],1.12;95%信赖区间 [CI], 0.75 - 1.69;P = .57)。
  
  此外,34周前没有自发性生产之妇女的累计百分比,两组之间并无显著差异(子宫托组风险比为1.13;95% CI, 0.77 - 1.65;P = .54)。
  
  在试验受试者招募时,子宫托组报告有阴道分泌物的比率高于对照组(10.5% vs 6.2%;P = .02),但是骨盆腔不适比率没有差异(分别是1.9%和0.6%;P = 0.14)。
  
  在追踪期间,子宫托组在阴道分泌物新发生或增加的比率(46.8% vs 13.8%;P < .001)和骨盆腔不适的比率(11.4% vs 3.4%;P < .001)都比较高。
  
  阴道抹片的病原菌,包括白色念珠菌、B 型链球菌或阴道嗜血杆菌,子宫托组和对照组的发生百分比相当,在招募时(分别是28.6%和25.8%;P = .39)与追踪期间的任何时间点(分别是31.4%和30.0%;P = .75)时都是。
  
  研究者写道,虽然子宫托组在阴道分泌物新发生或增加的比率是对照组的3倍以上,两组在子宫颈阴道感染的比率上并无显著差异。
  
  子宫颈子宫托组者中,114人(24.5%)在妊娠34周前移除,原因包括:医源性生产(6人)、早产(20人)、早产或产前胎膜破裂(41人)以及研究对象要求(47人:25因为不适、19人因为阴道分泌物、3人因为阴道出血)。
  
  研究者发现,两组在周产期前后死亡(OR, 1.38;95% CI, 0.63 - 3.04;P = .42)、新生儿不良事件(OR, 1.18;95% CI, 0.69 - 2.03;P = .55)或新生儿特殊照护(OR, 0.88;95% CI, 0.59 - 1.31;P = .59)等方面无显著差异。
  
  研究者结论表示,妊娠20-24周、子宫颈长度25mm以下、怀单胞胎的妇女中,相较于期待性处理法,放置子宫颈子宫托不会降低自发性早期早产比率。放置子宫托也不会影响周产期前后死亡、新生儿不良事件、新生儿特殊照护需求等比率。
  
  资料来源:http://www.24drs.com/
  
  Native link:Cervical Pessary Does Not Reduce Early Preterm Birth

Cervical Pessary Does Not Reduce Early Preterm Birth

By Troy Brown, RN
Medscape Medical News

A cervical pessary does not reduce the rate of spontaneous early preterm birth in women and girls with a shortened cervix compared with expectant management, a new multicenter, randomized controlled trial shows.

Kypros H. Nicolaides, MD, from the Harris Birthright Research Center for Fetal Medicine, King's College, London, United Kingdom, and colleagues report their findings in an article published in the March 17 issue of the New England Journal of Medicine.

A cervical pessary is a silicone device that is placed around the cervix transvaginally. It supports the cervix and reduces direct pressure from the uterus on the cervical canal by directing the cervix toward the sacrum.

The trial enrolled females aged at least 16 years with singleton pregnancies who had routine ultrasonographic examination at between 20 weeks 0 days and 24 weeks 6 days of gestation that showed a cervical length of 25 mm or less. Those with a cervical length of 15 mm or less at any time during the study were also treated with vaginal progesterone.

The researchers randomly assigned 466 participants to the cervical pessary group and 469 to the expectant management group.

Spontaneous birth before 34 weeks' gestation, which was the primary endpoint of the trial, occurred in 55 (12.0%) of those in the pessary group and 50 (10.8%) of those in the control group (odds ratio [OR] in the pessary group, 1.12; 95% confidence interval [CI], 0.75 - 1.69; P = .57).

Moreover, the cumulative percentage of women and girls who did not deliver spontaneously before 34 weeks was not significantly different between the two groups (hazard ratio in the pessary group, 1.13; 95% CI, 0.77 - 1.65; P = .54).

At trial recruitment, the rate of reported vaginal discharge was higher in the cervical pessary group than the control group (10.5% vs 6.2%; P = .02), but the rate of pelvic discomfort was not (1.9% and 0.6%, respectively; P = 0.14).

During follow-up, the rate of increased or new vaginal discharge (46.8% vs 13.8%; P < .001) and pelvic discomfort (11.4% vs 3.4%; P < .001) were both higher in the cervical pessary group.

The pessary group and the control group had similar percentages of participants with pathogens in the vaginal swabs, including Candida albicans, group B streptococcus, or Gardnerella vaginalis, both at recruitment (28.6% and 25.8%, respectively; P = .39) and at any time during follow-up (31.4% and 30.0%, respectively; P = .75).

"Although the rate of new or increased vaginal discharge was more than three times as high in the pessary group as in the control group, rates of cervicovaginal infection did not differ significantly between the groups," the researchers write.

Of those with cervical pessaries, 114 (24.5%) had them removed before 34 weeks' gestation for reasons including iatrogenic delivery (six participants), preterm labor (20 participants), preterm labor or prelabor rupture of membranes (41 participants), and participant request (47 participants; 25 for discomfort, 19 for vaginal discharge, and 3 for vaginal bleeding).

The researchers found no significant between-group differences in perinatal death (OR, 1.38; 95% CI, 0.63 - 3.04; P = .42), adverse neonatal event (OR, 1.18; 95% CI, 0.69 - 2.03; P = .55), or neonatal special care (OR, 0.88; 95% CI, 0.59 - 1.31; P = .59).

"[A]mong girls and women with singleton pregnancies who had a cervical length of 25 mm or less at 20 to 24 weeks of gestation, placement of a cervical pessary did not result in a lower rate of spontaneous early preterm delivery than the rate with expectant management," conclude the researchers. "Pessary placement also did not affect the rates of perinatal death, adverse neonatal outcomes, or the need for neonatal special care."

The authors have disclosed no relevant financial relationships.

N Engl J Med. 2016;374:1044-1052.

    
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