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17α-羟孕酮对降低辅助生殖技术(ART)妊娠早产率的疗效:一项随机临床试验。

Efficacy of 17α- hydroxy progestrone on decreasing preterm labor in ART pregnancies: A randomized clinical trial.

作者信息

Aflatoonian Abbas, Amouzegar Hoora, Dehghani Firouzabadi Razieh

机构信息

Department of Obstetrics and Gynecology, Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.

出版信息

Iran J Reprod Med. 2013 Oct;11(10):785-90.

PMID:24639698
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3941339/
Abstract

BACKGROUND

Preterm labor (PTL) is one of the most important causes in neonatal mortality and morbidity. Late preterm labor (34-36w) includes 75% of such birth. Assisted reproductive technology (ART) pregnant women are at increased risk of PTL.

OBJECTIVE

The study has been undertaken to determine whether beginning and continuing 17-α hydroxy progesterone caproate can reduce risk of PTL or change neonatal mortality.

MATERIALS AND METHODS

In a double-blind clinical randomized control trial, 106 women were treated by ART technique for their infertility and in gestational age at 16 weeks entered in our study. In one group, 17-α hydroxy progesterone caproate (Femolife) was injected intramuscularly every week until 36 weeks of gestation and in another group; placebo was injected from 16 until 36 weeks of gestetion. Data collected from pregnancy outcomes, infancy, and subsidiary problems were statistically analyzed by a questionnaire.

RESULTS

The risk of PTL in placebo group was 2.48 higher than control group that was not significant (Cl: 0.81-9.94). Femolife side effect in case group was gestational diabetes and local complication was not frequent. NICU admission was not significantly different between groups.

CONCLUSION

Although it seems that 17-α hydroxy progesterone caproate does not cause significantly decrease in PTL in singleton ART gestations but any reduction of PTL in such high risk pregnancies may improve final gestational outcome. There is critical need for larger clinical trials to better understanding causes of PTL, specifically late preterm labor, to prevent mortality and morbidity in ART gestation. This article extracted from Residential thesis. (Hoora Amouzegar)

REGISTRATION ID IN IRCT

IRCT2012101611132N1.

摘要

背景

早产是新生儿死亡和发病的最重要原因之一。晚期早产(34 - 36周)占此类分娩的75%。辅助生殖技术(ART)孕妇发生早产的风险增加。

目的

本研究旨在确定开始并持续使用己酸17-α羟孕酮是否能降低早产风险或改变新生儿死亡率。

材料与方法

在一项双盲临床随机对照试验中,106名因不孕症接受ART技术治疗且孕16周的妇女进入本研究。一组每周肌肉注射己酸17-α羟孕酮(Femolife)直至孕36周,另一组从孕16周直至孕36周注射安慰剂。通过问卷对收集的妊娠结局、婴儿期和附属问题的数据进行统计学分析。

结果

安慰剂组的早产风险比对照组高2.48倍,但差异无统计学意义(置信区间:0.81 - 9.94)。病例组中Femolife的副作用为妊娠期糖尿病,局部并发症不常见。两组间新生儿重症监护病房(NICU)入院率差异无统计学意义。

结论

尽管己酸17-α羟孕酮似乎并未显著降低单胎ART妊娠的早产率,但在这类高危妊娠中早产率的任何降低都可能改善最终妊娠结局。迫切需要进行更大规模的临床试验,以更好地了解早产尤其是晚期早产的原因,从而预防ART妊娠中的死亡和发病情况。本文摘自学位论文。(胡拉·阿莫泽加尔)

伊朗临床试验注册中心注册号

IRCT2012101611132N1

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8079/3941339/e4aaed3caf9c/ijrm-11-785-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8079/3941339/e4aaed3caf9c/ijrm-11-785-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8079/3941339/e4aaed3caf9c/ijrm-11-785-g001.jpg

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