孕中期遗传羊膜腔穿刺术前抗生素预防（APGA）：一项单中心开放随机对照试验。

Antibiotic prophylaxis before second-trimester genetic amniocentesis (APGA): a single-centre open randomised controlled trial.

作者信息

Giorlandino Claudio, Cignini Pietro, Cini Marco, Brizzi Cristiana, Carcioppolo Ornella, Milite Vincenzo, Coco Claudio, Gentili Paolo, Mangiafico Lucia, Mesoraca Alvaro, Bizzoco Domenico, Gabrielli Ivan, Mobili Luisa

机构信息

Department of Prenatal Diagnosis, Artemisia Fetal-Maternal Medical Centre, Rome, Italy.

出版信息

Prenat Diagn. 2009 Jun;29(6):606-12. doi: 10.1002/pd.2256.

DOI:10.1002/pd.2256

PMID:19294678

Abstract

OBJECTIVE

To compare procedure-related pregnancy loss after second-trimester genetic amniocentesis in women given an antibiotic prophylaxis and controls.

METHODS

Prospective, open randomised controlled single-centre study between January 1999 and December 2005 at Artemisia Fetal Maternal Medical Centre. A follow-up within 4 weeks after the procedure was done.Of 36,347 eligible women, 1424 refused to participate and 34,923 were enrolled and randomised with unequal chance of selection, 21,991 were assigned to treatment group and 12,932 were assigned to the control group, and did not receive any placebo. Oral azithromycin, 500 mg per day, was administered 3 days before amniocentesis. The primary endpoint was the procedure-related pregnancy loss. The secondary endpoint was the rate of preterm premature rupture of membranes.

RESULTS

The rate of abortion related to the amniocentesis was 7/21 219 women (0.03%, 95% CI 0.009-0.057) in the intervention group, and 36/12 529 (0.28%, 0.28-0.30) in controls (p = 0.0019). The rate of preterm premature rupture of membranes was 14/21 219 (0.06%, 0.031-0.101) in the intervention group, and 140/12 529 (1.12%, 0.94-1.30) in the control group (p = 0.001).

CONCLUSIONS

Antibiotic prophylaxis before second-trimester amniocentesis reduced the risk of abortion and of rupture of the membranes.

摘要

目的

比较接受抗生素预防治疗的孕妇与对照组孕妇在孕中期进行遗传羊膜穿刺术后与手术相关的妊娠丢失情况。

方法

1999年1月至2005年12月在蒿属胎儿-母体医学中心进行的一项前瞻性、开放性随机对照单中心研究。术后4周内进行随访。在36347名符合条件的女性中，1424人拒绝参与，34923人被纳入并以不等的入选概率进行随机分组，21991人被分配到治疗组，12932人被分配到对照组，且未接受任何安慰剂。在羊膜穿刺术前3天口服阿奇霉素，每日500毫克。主要终点是与手术相关的妊娠丢失。次要终点是胎膜早破率。

结果

干预组中与羊膜穿刺术相关的流产率为7/21219名女性（0.03%，95%可信区间0.009 - 0.057），对照组为36/12529（0.28%，0.28 - 0.30）（p = 0.0019）。干预组胎膜早破率为14/21219（0.06%，0.031 - 0.101），对照组为140/12529（1.12%，0.94 - 1.30）（p = 0.001）。