Australian Research Centre for the Health of Women and Babies (ARCH), Discipline of Obstetrics and Gynaecology, The University of Adelaide, Adelaide, Australia.
BMC Pregnancy Childbirth. 2010 Oct 25;10:68. doi: 10.1186/1471-2393-10-68.
There is a well recognized risk of complications for both women and infants of a twin pregnancy, increasing beyond 37 weeks gestation. Preterm birth prior to 37 weeks gestation is a recognized complication of a twin pregnancy, however, up to 50% of twins will be born after this time. The aims of this randomised trial are to assess whether elective birth at 37 weeks gestation compared with standard care in women with a twin pregnancy affects the risk of perinatal death, and serious infant complications.
Multicentred randomised trial.
women with a twin pregnancy at 366 weeks or more without contraindication to continuation of pregnancy. Trial Entry & Randomisation: Following written informed consent, eligible women will be randomised from 36+6 weeks gestation. The randomisation schedule uses balanced variable blocks, with stratification for centre of birth and planned mode of birth. Women will be randomised to either elective birth or standard care. Treatment Schedules: Women allocated to the elective birth group will be planned for elective birth from 37 weeks gestation. Where the plan is for vaginal birth, this will involve induction of labour. Where the plan is for caesarean birth, this will involve elective caesarean section. For women allocated to standard care, birth will be planned for 38 weeks gestation or later. Where the plan is for vaginal birth, this will involve either awaiting the spontaneous onset of labour, or induction of labour if required. Where the plan is for caesarean birth, this will involve elective caesarean section (after 38 and as close to 39 weeks as possible). Primary Study Outcome: A composite of perinatal mortality or serious neonatal morbidity.
460 women with a twin pregnancy to show a reduction in the composite outcome from 16.3% to 6.7% with adjustment for the clustering of twin infants within mothers (p = 0.05, 80% power).
This is a protocol for a randomised trial, the findings of which will contribute information about the optimal time of birth for women with an uncomplicated multiple pregnancy at and beyond 37 weeks gestation.
对于双胎妊娠的妇女和婴儿来说，并发症的风险是众所周知的，而且这种风险会随着妊娠超过 37 周而增加。在妊娠 37 周之前早产是双胎妊娠的一种公认并发症，然而，多达 50%的双胞胎会在这个时间之后出生。本随机试验的目的是评估在 37 周妊娠时与标准护理相比，选择性分娩对双胎妊娠的围产儿死亡和严重婴儿并发症的风险是否有影响。
多中心随机试验。
妊娠 36+6 周及以上的双胎妊娠妇女，且无继续妊娠的禁忌证。试验入组和随机化：在获得书面知情同意后，符合条件的妇女将在 36+6 周妊娠时进行随机分组。随机分组方案使用平衡的变量块，并按分娩中心和计划分娩方式进行分层。妇女将被随机分配到选择性分娩组或标准护理组。
被分配到选择性分娩组的妇女将计划在 37 周妊娠时进行选择性分娩。如果计划是阴道分娩，则将进行引产。如果计划是剖宫产，则将进行选择性剖宫产。对于被分配到标准护理组的妇女，分娩将计划在 38 周妊娠或之后进行。如果计划是阴道分娩，则将等待自然发动产程，或在需要时进行引产。如果计划是剖宫产，则将进行选择性剖宫产（在 38 周后并尽可能接近 39 周）。
围产儿死亡率或严重新生儿发病率的复合结果。
460 例双胎妊娠妇女，以显示复合结果从 16.3%降低至 6.7%，同时调整了母亲内双胞胎婴儿的聚类效应（p = 0.05，80%效力）。
这是一项随机试验的方案，其研究结果将提供关于在 37 周及以上的无并发症多胎妊娠妇女的最佳分娩时间的信息。
