Department of Obstetrics and Gynecology, Amsterdam UMC - Location AMC, Amsterdam, The Netherlands.
Pediatric Clinical Research Office, Emma Children's Hospital Amsterdam UMC - Location AMC, Amsterdam, The Netherlands.
Acta Obstet Gynecol Scand. 2019 Oct;98(10):1292-1300. doi: 10.1111/aogs.13630. Epub 2019 Jun 18.
The ProTWIN trial previously showed no beneficial effect of treatment with a cervical pessary vs usual care to prevent preterm birth in women with a multiple pregnancy. However, in women with a midtrimester short cervix (<38 mm), pessary did reduce the composite outcome of neonatal morbidity and mortality. This follow-up study evaluates the long-term outcomes of all children born to mothers who participated in the ProTWIN trial at 4 years of age.
Parents received the Ages and Stages Questionnaire, Strength and Difficulties Questionnaire and a health questionnaire. All questionnaires were reported separately and as a combined outcome (abnormal child outcome). A linear mixed effects model was used to adjust for correlated data in twins and correction for confounders was performed. In exploratory analysis, a composite outcome of death or survival with abnormal child outcome was used by combining extrapolated data on child outcome with survival data. All data were analyzed for the total group and the subgroup of women with midtrimester short cervix.
Of the original 813 women of the ProTWIN trial, we approached 579, of whom 258 participated (45%) in follow-up. We received questionnaires of 514 children (281 pessary vs 233 control), with 119 children in the subgroup of women with midtrimester short cervix. An abnormal child outcome was found in 23% in the pessary group vs 16% in the control group (odds ratio 1.58; 95% confidence interval 0.94-2.65). In exploratory analysis with extrapolated data on child outcome (n = 815), no difference in abnormal child outcome was seen between the pessary and control group. In the subgroup of women with a short cervix (n = 268), this composite outcome indicated a favorable outcome for children born to mothers with pessary.
In women with a multiple pregnancy, the use of a cervical pessary did not improve development, behavior or physical outcomes of the surviving children at age 4.
ProTWIN 试验先前表明，在多胎妊娠妇女中，使用宫颈扩张器治疗与常规护理相比，不能预防早产。然而，在中孕期宫颈短（<38mm）的妇女中，扩张器确实降低了新生儿发病率和死亡率的复合结局。这项随访研究评估了所有参加 ProTWIN 试验的母亲所生的孩子在 4 岁时的长期结局。
父母收到了年龄和阶段问卷、力量和困难问卷以及健康问卷。所有问卷均单独报告，并作为综合结局（儿童异常结局）报告。使用线性混合效应模型调整双胞胎的相关数据，并进行混杂因素校正。在探索性分析中，通过将儿童结局的外推数据与生存数据相结合，使用死亡或生存伴有儿童异常结局的复合结局。所有数据均在总组和中孕期宫颈短的妇女亚组中进行分析。
在 ProTWIN 试验的 813 名原始女性中，我们联系了 579 名，其中 258 名（45%）参加了随访。我们收到了 514 名儿童的问卷（281 名使用扩张器，233 名对照组），其中 119 名在中孕期宫颈短的妇女亚组中。扩张器组有 23%的儿童出现异常结局，对照组为 16%（比值比 1.58；95%置信区间 0.94-2.65）。在使用儿童结局外推数据的探索性分析中（n=815），扩张器组与对照组之间未见异常儿童结局的差异。在宫颈短的妇女亚组（n=268）中，扩张器对母亲的儿童有更好的复合结局。
在多胎妊娠妇女中，使用宫颈扩张器并不能改善 4 岁时存活儿童的发育、行为或身体结局。
