Lancet:早产高危女性是否应预防性使用孕酮(OPPTIMUM研究)

2016-02-24 MedSci MedSci原创

Lancet:早产高危女性是否应预防性使用孕酮(OPPTIMUM研究)已有研究表明,孕酮的应用可降低高危孕妇早产的发生风险并可降低新生儿发病率,但有尚不能确定孕酮的使用对孩子日后长期的影响。研究人员设计了一项双盲随机安慰剂对照试验,探究了阴道黄体酮对早产高危女性早产的发生风险以及新生儿健康状况的影响(存在早产史,自然分娩孕期≤34周,或孕期为0天,或宫颈长度≤25 mm,或胎儿纤维连接蛋白检测阳性

已有研究表明,孕酮的应用可降低高危孕妇早产的发生风险并可降低新生儿发病率,但有尚不能确定孕酮的使用对孩子日后长期的影响。

研究人员设计了一项双盲随机安慰剂对照试验,探究了阴道黄体酮对早产高危女性早产的发生风险以及新生儿健康状况的影响(存在早产史,自然分娩孕期≤34周,或孕期为0天,或宫颈长度≤25 mm,或胎儿纤维连接蛋白检测阳性联合早产的其他临床危险因素[既往妊娠早产中存在的任何一个危险因素,妊娠中期流产,胎膜早破早产,或曾因宫颈涂片异常而行宫颈手术])。该研究旨在确定预防性使用阴道孕酮是否可减少早产对新生儿和儿童健康的影响。

主要研究结果:妊娠失败或妊娠期不足34周和妊娠0天,复合死亡,脑损伤,或支气管肺发育不良(新生儿),和儿童两岁时的标准化认知得分(童年)。通过网站进行随机抽样,所有的研究对象、研究人员以及其他参与干预、评估结果或分析数据的人员均在不了解试验分组情况下进行研究。

2009年2月2日至2013年4月12日期间,研究人员共纳入了1228名女性,随机分配至安慰剂组(610名)和孕酮组(618名)。安慰剂组,587名女性可用于分娩分析,597名婴儿可用于新生儿结局分析,439名婴儿可用于儿童健康结果的分析。孕酮组则分别为600名,589名以及430名。校正多个结果后,发现孕酮并未明显影响主要产科结局和新生儿结局,也并未明显影响儿童童年时期的健康状况(认知得分,孕激素组:安慰剂组 = 97.3:97.7)。安慰剂组共有70名(11%)患者出现严重不良事件,而孕酮组则有616名(10%)患者出现严重不良反应事件。

总而言之,阴道孕酮并不会降低早产或新生儿不良结局的发生风险,且在儿童2岁前对其健康也并无明显影响。

原始出处:

Jane Elizabeth Norman, Neil Marlow, et al., Vaginal progesterone prophylaxis for preterm birth (the OPPTIMUM study): a multicentre, randomised, double-blind trial. The Lancet, February 22, 2016.


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    2016-06-18 howi
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    2016-02-28 zm0805

    0

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    2016-02-28 zm0805

    厉害

    0

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    2016-02-26 周虎
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    2016-02-25 sillywu

    生个孩子硬是被搞得这么复杂

    0

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