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经腹羊膜腔灌注治疗早产胎膜早破:一项随机对照试验

Transabdominal amnioinfusion in preterm premature rupture of membranes: a randomised controlled trial.

作者信息

Tranquilli Andrea Luigi, Giannubilo Stefano Raffaele, Bezzeccheri Valeria, Scagnoli Caterina

机构信息

Department of Obstetrics and Gynaecology, Polytechnical University of Marche, Ancona, Italy.

出版信息

BJOG. 2005 Jun;112(6):759-63. doi: 10.1111/j.1471-0528.2005.00544.x.

Abstract

OBJECTIVE

To evaluate the role of transabdominal amnioinfusion in improving the perinatal outcomes of pregnancies complicated by preterm premature rupture of membranes (pPROM).

DESIGN

A randomised controlled trial.

SETTING

A teaching hospital in Italy, obstetric unit. Population Women with singleton pregnancies complicated by pPROM, between 24 + 0 and 32 + 6 weeks of gestation.

METHODS

Patients were randomised 24 hours after admission to our referral hospital, to expectant management with transabdominal amnioinfusion or expectant management only.

MAIN OUTCOME MEASURES

The effects of transabdominal amnioinfusion on pPROM-delivery interval and on perinatal outcomes.

RESULTS

Of the 65 women with pPROM 34 met the inclusion criteria. Seventeen women were assigned to amnioinfusion (the amnioinfusion group) and the other 17 to expectant management. Compared with the control group (median: 8 days; range: 3-14), the pPROM-delivery period was significantly longer in women who underwent amnioinfusion (median: 21 days; range: 15-29) (P < 0.05). Women with amnioinfusion were less likely to deliver within seven days since pPROM (RR: 0.18; range: 0.04-0.69 95% CI) or within two weeks (RR: 0.46; range: 0.21-1.02 95% CI). In the amnioinfusion group the neonatal survival was significantly higher at each gestational age (P < 0.01, Yates's correction for Log Rank Test) with a reduction in pulmonary hypoplasia.

CONCLUSIONS

We demonstrated that compared with standard expectant management the treatment with transabdominal amnioinfusion after pPROM resulted in significant prolongation of pregnancy and better neonatal outcomes.

摘要

目的

评估经腹羊膜腔灌注在改善妊娠合并早产胎膜早破(pPROM)围产期结局中的作用。

设计

一项随机对照试验。

地点

意大利一家教学医院的产科病房。研究对象为单胎妊娠合并pPROM、孕周在24 + 0至32 + 6周之间的孕妇。

方法

患者入院24小时后被随机分为两组,一组接受经腹羊膜腔灌注的期待治疗,另一组仅接受期待治疗。

主要观察指标

经腹羊膜腔灌注对pPROM至分娩间隔时间及围产期结局的影响。

结果

65例pPROM患者中34例符合纳入标准。17例患者被分配至羊膜腔灌注组(羊膜腔灌注组),另外17例接受期待治疗。与对照组(中位数:8天;范围:3 - 14天)相比,接受羊膜腔灌注的患者pPROM至分娩的时间显著延长(中位数:21天;范围:15 - 29天)(P < 0.05)。羊膜腔灌注组患者在pPROM后7天内分娩(RR:0.18;范围:0.04 - 0.69,95%CI)或2周内分娩(RR:0.46;范围:0.21 - 1.02,95%CI)的可能性较小。在羊膜腔灌注组,各孕周的新生儿存活率显著更高(P < 0.01,对数秩检验的耶茨校正),肺发育不全的情况有所减少。

结论

我们证明,与标准期待治疗相比,pPROM后经腹羊膜腔灌注治疗可显著延长孕周并改善新生儿结局。

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