Study protocol of SWEPIS a Swedish multicentre register based randomised controlled trial to compare induction of labour at 41 completed gestational weeks versus expectant management and induction at 42 completed gestational weeks
Study protocol of SWEPIS a Swedish multicentre register based randomised controlled trial to compare induction of labour at 41 completed gestational weeks versus expectant management and induction at 42 completed gestational weeks
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DOI：
10.1186/s12884-016-0836-9
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发表时间：
2016-03-07
影响因子：
3.1
通讯作者：
Wennerholm, Ulla-Britt
中科院分区：
文献类型：
--
作者：
Elden, Helen;Hagberg, Henrik;Wennerholm, Ulla-Britt
背景：观察数据显示，与足月妊娠相比，过期妊娠（>= 42 孕周，GW）和晚期妊娠（>= 41 GW）与母亲和婴儿不良结局的风险增加相关。许多国家的标准护理是 42 GW 的引产。没有足够的科学证据表明，与期待管理和 42 吉瓦引产相比，41 吉瓦引产将降低围产儿死亡率和发病率，而不会增加手术分娩、不良分娩经历或更高的成本。由于结果重要，因此需要进行大型随机研究；围产期死亡率和缺氧缺血性脑病等罕见事件。 方法/设计：总共 10 038 名年龄 >= 18 岁的健康女性，在 41 吉瓦时头位正常活单胎妊娠，通过妊娠早期或中期超声评估，能够理解口头和书面信息，将被随机分配到 41 吉瓦时进行引产（早期引产）或在 42 吉瓦时进行期待管理和引产（晚期）。感应）。瑞典的大学诊所和县医院将招募女性，每年分娩超过 65,000 例。主要结局是死产、新生儿死亡率和严重新生儿发病率的综合结果。次要结局是其他不良的新生儿和孕产妇结局、分娩方式、妇女的经历、成本效益和 3 个月以下的婴儿发病率。有关背景变量、产科和新生儿结局的数据将从瑞典妊娠登记处和瑞典新生儿质量登记处获得。有关女性经历的数据将在随机分组后和分娩后 3 个月内通过问卷收集。初步分析将是意向治疗。统计学家对分组和干预措施不知情。讨论：为了减少儿童的死亡和终身残疾，调查 41 GW 时的干预措施是否优于标准护理非常重要。怀孕人口>41GW，占所有怀孕的15-20%，因此研究结果将产生巨大影响。使用登记进行随机化和收集结果数据代表了一种独特的新研究设计。
Background: Observational data shows that postterm pregnancy (>= 42 gestational weeks, GW) and late term pregnancy (>= 41 GW), as compared to term pregnancy, is associated with an increased risk for adverse outcome for the mother and infant. Standard care in many countries is induction of labour at 42 GW. There is insufficient scientific support that induction of labour at 41 GW, as compared with expectant management and induction at 42 GW will reduce perinatal mortality and morbidity without an increase in operative deliveries, negative delivery experiences or higher costs. Large randomised studies are needed since important outcomes; such as perinatal mortality and hypoxic ischaemic encephalopathy are rare events.Methods/Design: A total of 10 038 healthy women >= 18 years old with a normal live singleton pregnancy in cephalic presentation at 41 GW estimated with a first or second trimester ultrasound, who is able to understand oral and written information will be randomised to labour induction at 41 GW (early induction) or expectant management and induction at 42 GW (late induction). Women will be recruited at university clinics and county hospitals in Sweden comprising more than 65 000 deliveries per year. Primary outcome will be a composite of stillbirth, neonatal mortality and severe neonatal morbidity. Secondary outcomes will be other adverse neonatal and maternal outcomes, mode of delivery, women's experience, cost effectiveness and infant morbidity up to 3 months of age. Data on background variables, obstetric and neonatal outcomes will be obtained from the Swedish Pregnancy Register and the Swedish Neonatal Quality Register. Data on women's experiences will be collected by questionnaires after randomisation and 3 months after delivery. Primary analysis will be intention to treat. The statistician will be blinded to group and intervention.Discussion: It is important to investigate if an intervention at 41 GW is superior to standard care in order to reduce death and lifelong disability for the children. The pregnant population, >41 GW, constitutes 15-20 % of all pregnancies and the results of the study will thus have a great impact. The use of registries for randomisation and collection of outcome data represents a unique and new study design.