Berghella Vincenzo, Hayes Edward, Visintine John, Baxter Jason K
Division of Maternal Fetal Medicine, Thomas Jefferson University, 834 Chestnut Street, Suite 400, Philadelphia, PA 19107, USA.
Cochrane Database Syst Rev. 2008 Oct 8;2008(4):CD006843. doi: 10.1002/14651858.CD006843.pub2.
Fetal fibronectin (FFN) is an extracellular matrix glycoprotein localized at the maternal-fetal interface of the amniotic membranes, between chorion and decidua, where it is concentrated in this area between decidua and trophoblast. In normal conditions, FFN is found at very low levels in cervico-vaginal secretions. Levels greater than or equal to 50 ng/mL at or after 22 weeks have been associated with an increased risk of spontaneous preterm birth. In fact, FFN is one of the best predictors of preterm birth in all populations studied so far, and can help selecting which women are at significant risk for preterm birth.
To assess the effectiveness of management based on knowledge of FFN testing results for preventing preterm birth.
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (January 2008), MEDLINE (1966 to December 2007) and all references in identified articles.
Randomized controlled trials of pregnant women between the gestational ages of 22 and 34 weeks screened with FFN for risk of preterm birth. Studies included are based exclusively on knowledge of FFN results versus no such knowledge, and we have excluded studies including women with only positive or only negative FFN results.
All four authors assessed studies for inclusion and quality and extracted data.
We identified 13 trials, of which five were eligible for inclusion. The five included studies randomized 474 women, of which 235 were randomized to knowledge and 249 to no knowledge of FFN.Preterm birth less than 37 weeks was significantly decreased with management based on knowledge of FFN results (15.6%) versus controls without such knowledge (28.6%; risk ratio 0.54; 95% confidence interval 0.34 to 0.87). All other outcomes for which there were available data (preterm birth at less than 34, 32, or 28 weeks; gestational age at delivery; birthweight less than 2500 grams; perinatal death; maternal hospitalization; tocolysis; steroids for fetal lung maturity; and time to evaluate) were similar in the two groups. No other maternal or neonatal outcome was available for meaningful analysis.
AUTHORS' CONCLUSIONS: Although FFN is commonly used in labor and delivery units to help in the management of women with symptoms of preterm labor, currently there is not sufficient evidence to recommend its use. Since this review found an association between knowledge of FFN results and a lower incidence of preterm birth before 37 weeks, further research should be encouraged.
胎儿纤连蛋白(FFN)是一种细胞外基质糖蛋白,定位于羊膜的母胎界面,在绒毛膜和蜕膜之间,在蜕膜和滋养层之间的这个区域富集。在正常情况下,宫颈阴道分泌物中FFN水平极低。孕22周及以后,FFN水平大于或等于50 ng/mL与自发性早产风险增加相关。事实上,FFN是迄今为止所有研究人群中早产的最佳预测指标之一,有助于筛选出哪些女性有早产的显著风险。
评估基于FFN检测结果的知识进行管理对预防早产的有效性。
我们检索了Cochrane妊娠与分娩组试验注册库(2008年1月)、MEDLINE(1966年至2007年12月)以及已识别文章中的所有参考文献。
对孕22至34周的孕妇进行FFN筛查早产风险的随机对照试验。纳入的研究仅基于FFN结果的知识与无此类知识的对比,我们排除了仅纳入FFN结果为阳性或阴性的女性的研究。
四位作者均评估研究是否纳入及质量,并提取数据。
我们识别出13项试验,其中5项符合纳入标准。这5项纳入研究将474名女性随机分组,其中235名被随机分配到知晓FFN结果组,249名被随机分配到不知晓FFN结果组。基于FFN结果知识的管理使37周前早产显著减少(15.6%),而不知晓此类知识的对照组为28.6%(风险比0.54;95%置信区间0.34至0.87)。两组中所有其他有可用数据的结局(34周、32周或28周前早产;分娩时孕周;出生体重低于2500克;围产期死亡;产妇住院;宫缩抑制剂使用;促进胎儿肺成熟的类固醇使用;以及评估时间)相似。没有其他有意义的产妇或新生儿结局可供分析。
尽管FFN常用于分娩单元以帮助管理有早产症状的女性,但目前尚无足够证据推荐使用。由于本综述发现知晓FFN结果与37周前早产发生率较低之间存在关联,应鼓励进一步研究。