子宮頸子宮托無法減少早期早產風險


  【24drs.com】一篇多中心隨機控制試驗顯示,相較於期待性處理法,子宮頸子宮托無法減少短子宮頸之婦女的自發性早期早產風險比率。
  
  英國倫敦國王學院Harris胎兒醫學生產權研究中心Kypros H. Nicolaides醫師等人在3月17日的新英格蘭醫學期刊發表他們的研究結果。
  
  子宮頸子宮托是放置在子宮頸陰道周圍、矽氧樹脂材質的一種器具,它可以支撐子宮頸、讓子宮頸朝向骶骨,而減少子宮對子宮頸管的直接壓力。
  
  該試驗的研究對象是,懷有單胞胎的16歲以上女性、在妊娠20週0天至24週6天這段期間進行例行性超音波檢查,子宮頸長度為25 mm以下者;在研究期間的任何時間點,子宮頸長度15 mm以下者,給予陰道黃體素治療。
  
  研究者隨機指定466名研究對象到子宮頸子宮托組,469名到期待性處理法這組。
  
  該研究的初級終點是妊娠34週前自發性生產,子宮托組有55人(12.0%)發生,對照組則是有50人(10.8%)發生(子宮托組勝算比[OR],1.12;95%信賴區間 [CI], 0.75 - 1.69;P = .57)。
  
  此外,34週前沒有自發性生產之婦女的累計百分比,兩組之間並無顯著差異(子宮托組風險比為1.13;95% CI, 0.77 - 1.65;P = .54)。
  
  在試驗受試者招募時,子宮托組報告有陰道分泌物的比率高於對照組(10.5% vs 6.2%;P = .02),但是骨盆腔不適比率沒有差異(分別是1.9%和0.6%;P = 0.14)。
  
  在追蹤期間,子宮托組在陰道分泌物新發生或增加的比率(46.8% vs 13.8%;P < .001)和骨盆腔不適的比率(11.4% vs 3.4%;P < .001)都比較高。
  
  陰道抹片的病原菌,包括白色念珠菌、B 型鏈球菌或陰道嗜血桿菌,子宮托組和對照組的發生百分比相當,在招募時(分別是28.6%和25.8%;P = .39)與追蹤期間的任何時間點(分別是31.4%和30.0%;P = .75)時都是。
  
  研究者寫道,雖然子宮托組在陰道分泌物新發生或增加的比率是對照組的3倍以上,兩組在子宮頸陰道感染的比率上並無顯著差異。
  
  子宮頸子宮托組者中,114人(24.5%)在妊娠34週前移除,原因包括:醫源性生產(6人)、早產(20人)、早產或產前胎膜破裂(41人)以及研究對象要求(47人:25因為不適、19人因為陰道分泌物、3人因為陰道出血)。
  
  研究者發現,兩組在週產期前後死亡(OR, 1.38;95% CI, 0.63 - 3.04;P = .42)、新生兒不良事件(OR, 1.18;95% CI, 0.69 - 2.03;P = .55)或新生兒特殊照護(OR, 0.88;95% CI, 0.59 - 1.31;P = .59)等方面無顯著差異。
  
  研究者結論表示,妊娠20-24週、子宮頸長度25mm以下、懷單胞胎的婦女中,相較於期待性處理法,放置子宮頸子宮托不會降低自發性早期早產比率。放置子宮托也不會影響週產期前後死亡、新生兒不良事件、新生兒特殊照護需求等比率。
  
  資料來源: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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