Tajik P, Monfrance M, van 't Hooft J, Liem S M S, Schuit E, Bloemenkamp K W M, Duvekot J J, Nij Bijvank B, Franssen M T M, Oudijk M A, Scheepers H C J, Sikkema J M, Woiski M, Mol B W J, Bekedam D J, Bossuyt P M, Zafarmand M H
Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, The Netherlands.
Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre, Amsterdam, The Netherlands.
Ultrasound Obstet Gynecol. 2016 Jul;48(1):48-55. doi: 10.1002/uog.15855.
The ProTWIN Trial (NTR1858) showed that, in women with a multiple pregnancy and a cervical length < 25(th) percentile (38 mm), prophylactic use of a cervical pessary reduced the risk of adverse perinatal outcome. We investigated whether other maternal or pregnancy characteristics collected at baseline can improve identification of women most likely to benefit from pessary placement.
ProTWIN is a multicenter randomized trial in which 808 women with a multiple pregnancy were assigned to pessary or control. Using these data we developed a multivariable logistic model comprising treatment, cervical length, chorionicity, pregnancy history and number of fetuses, and the interaction of these variables with treatment as predictors of adverse perinatal outcome.
Short cervix, monochorionicity and nulliparity were predictive factors for a benefit from pessary insertion. History of previous preterm birth and triplet pregnancy were predictive factors of possible harm from pessary. The model identified 35% of women as benefiting (95% CI, 32-39%), which is 10% more than using cervical length only (25%) for pessary decisions. The model had acceptable calibration. We estimated that using the model to guide the choice of pessary placement would reduce the risk of adverse perinatal outcome significantly from 13.5% when no pessary is inserted to 8.1% (absolute risk reduction, 5.4% (95% CI, 2.1-8.6%)).
We developed and internally validated a multivariable treatment selection model, with cervical length, chorionicity, pregnancy history and number of fetuses. If externally validated, it could be used to identify women with a twin pregnancy who would benefit from a pessary, and lead to a reduction in adverse perinatal outcomes in these women. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.
ProTWIN试验（NTR1858）表明，对于怀有多胎且宫颈长度低于第25百分位数（38毫米）的女性，预防性使用宫颈托可降低不良围产期结局的风险。我们调查了基线时收集的其他母体或妊娠特征是否能改善对最可能从放置宫颈托中获益的女性的识别。
ProTWIN是一项多中心随机试验，808名怀有多胎的女性被分配至宫颈托组或对照组。利用这些数据，我们建立了一个多变量逻辑模型，该模型包含治疗、宫颈长度、绒毛膜性、妊娠史和胎儿数量，以及这些变量与治疗的相互作用，作为不良围产期结局的预测因素。
宫颈短、单绒毛膜性和未生育是从放置宫颈托中获益的预测因素。既往早产史和三胎妊娠是宫颈托可能造成危害的预测因素。该模型识别出35%的女性会从中获益（95%可信区间，32 - 39%），这比仅使用宫颈长度（25%）来决定是否使用宫颈托多了10%。该模型具有可接受的校准度。我们估计，使用该模型指导宫颈托放置的选择将使不良围产期结局的风险从不放置宫颈托时的13.5%显著降低至8.1%（绝对风险降低5.4%（95%可信区间，2.1 - 8.6%））。
我们开发并在内部验证了一个包含宫颈长度、绒毛膜性、妊娠史和胎儿数量的多变量治疗选择模型。如果能在外部得到验证，它可用于识别怀有双胎且将从宫颈托中获益的女性，并减少这些女性的不良围产期结局。版权所有© 2016国际妇产科超声学会。由约翰·威利父子有限公司出版。
