多胎妊娠孕妇用宫颈环预防早产（ProTWIN）：一项多中心、开放标签随机对照试验。
Cervical pessaries for prevention of preterm birth in women with a multiple pregnancy (ProTWIN): a multicentre, open-label randomised controlled trial.
机构信息
Obstetrics and Gynaecology, Academic Medical Center, Amsterdam, Netherlands.
出版信息
Lancet. 2013 Oct 19;382(9901):1341-9. doi: 10.1016/S0140-6736(13)61408-7. Epub 2013 Aug 5.
BACKGROUND
In women with a multiple pregnancy, spontaneous preterm delivery is the leading cause of perinatal morbidity and mortality. Interventions to reduce preterm birth in these women have not been successful. We assessed whether a cervical pessary could effectively prevent poor perinatal outcomes.
METHODS
We undertook a multicentre, open-label randomised controlled trial in 40 hospitals in the Netherlands. We randomly assigned women with a multiple pregnancy between 12 and 20 weeks' gestation (1:1) to pessary or control groups, using a web-based application with a computer-generated list with random block sizes of two to four, stratified by hospital. Participants and investigators were aware of group allocation. For women in the pessary group, a midwife or obstetrician inserted a cervical pessary between 16 and 20 weeks' gestation. Women in the control group did not receive the pessary, but otherwise received similar obstetrical care to those in the pessary group. The primary outcome was a composite of poor perinatal outcome: stillbirth, periventricular leucomalacia, severe respiratory distress syndrome, bronchopulmonary dysplasia, intraventricular haemorrhage, necrotising enterocolitis, proven sepsis, and neonatal death. Analyses were by modified intention to treat. This trial is registered in the Dutch trial registry, number NTR1858.
FINDINGS
Between Sept 21, 2009, and March 9, 2012, 813 women underwent randomisation, of whom 808 were analysed (401 in the pessary group; 407 in the control group). At least one child of 53 women (13%) in the pessary group had poor perinatal outcome, compared with 55 (14%) in the control group (relative risk 0·98, 95% CI 0·69-1·39).
INTERPRETATION
In unselected women with a multiple pregnancy, prophylactic use of a cervical pessary does not reduce poor perinatal outcome.
FUNDING
The Netherlands Organisation for Health Research and Development.
背景
在多胎妊娠的女性中，自发性早产是围产期发病率和死亡率的主要原因。针对这些女性的干预措施未能成功减少早产。我们评估了宫颈托是否能有效预防不良围产结局。
方法
我们在荷兰的 40 家医院进行了一项多中心、开放标签的随机对照试验。我们将妊娠 12-20 周的多胎妊娠女性（1:1）随机分配至宫颈托组或对照组，使用基于网络的应用程序，根据医院分层，使用大小为 2-4 的计算机生成随机分组列表进行分组。参与者和研究者均知晓分组情况。对于宫颈托组的女性，助产士或妇产科医生在妊娠 16-20 周时放置宫颈托。对照组的女性不接受宫颈托，但接受与宫颈托组类似的产科护理。主要结局是不良围产结局的复合结局：死胎、脑室周围白质软化、严重呼吸窘迫综合征、支气管肺发育不良、脑室内出血、坏死性小肠结肠炎、证实的败血症和新生儿死亡。分析采用意向治疗进行修正。该试验在荷兰试验注册处登记，编号为 NTR1858。
结果
2009 年 9 月 21 日至 2012 年 3 月 9 日，813 名女性接受了随机分组，其中 808 名进行了分析（宫颈托组 401 名；对照组 407 名）。宫颈托组至少有 1 名 53 名女性（13%）的婴儿发生不良围产结局，而对照组有 55 名（14%）（相对风险 0.98，95%CI 0.69-1.39）。
解释
在未选择的多胎妊娠女性中，预防性使用宫颈托不能降低不良围产结局的风险。
资助
荷兰健康研究与发展组织。
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