孕期细菌性阴道炎早期临床治疗 (PREMEVA):多中心,双盲,随机对照试验
Damien Subtil1, Gilles Brabant2, Emma Tilloy1
1Pôle Femme Mère Nouveau-né, Centre Hospitalier Universitaire de Lille, Lille, France; Epidémiologie et Qualité des soins (EA 2694), Université de Lille, Lille, France.
Lancet (London, England)
|October 17, 2018
概括
治疗孕妇的细菌性阴道炎并没有减少晚期流产或非常早产. 在这个群体中使用抗生素预防早产需要重新考虑.
科学领域:
- 产科和妇科
- 产妇和胎儿医学
- 怀孕期间的传染病
背景情况:
- 过早分娩 (<37周) 是围产死亡率和发病率的主要原因.
- 怀孕期间的细菌性阴道炎与包括早产在内的不良结果有关.
- 这项研究调查了治疗细菌性阴道炎是否会减少晚期流产或自发的非常早产.
研究的目的:
- 评估克林达米辛治疗细菌性阴道炎的有效性,以预防晚期流产或自发的非常早产.
- 评估低风险和高风险怀孕的结果.
- 确定抗生素干预是否有助于预防与细菌性阴道炎相关的不良妊娠结果.
主要方法:
- 在40个法国中心进行双盲随机对照试验.
- 纳入标准:18岁以上的女性有细菌性阴道炎和低风险或高风险的怀孕.
- 治疗组:单疗程克林达米辛,三疗程克林达米辛或安慰剂;主要结局:晚期流产 (16-21周) 或自发的非常早产 (22-32周).
主要成果:
- 在低风险怀孕 (n=2869) 中,克林达米辛和安慰剂组之间的初级结果没有显著差异 (1.2%与1. 0%,RR 1. 10;p=0. 82).
- 在高危孕妇 (n=236) 中,单疗程和三疗程之间没有显著差异 (4. 4% vs 6. 0%,RR 0. 67;p=0. 47).
- 在低风险试验中,克林达米辛组 (3. 0%) 的不良反应,主要是腹,比安慰剂 (1. 3%) 更频繁.
结论:
- 在低风险怀孕中,细菌性阴道炎的系统查和治疗不能减少晚期流产或自发的非常早产.
- 目前在该群体中预防早产的抗生素策略需要重新评估.
- 需要进一步的研究来确定有效的干预措施,以防止因细菌性阴道炎而复杂的怀孕.
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