Dodd Jodie M, Crowther Caroline A, Hiller Janet E, Haslam Ross R, Robinson Jeffrey S
Discipline of Obstetrics and Gynaecology, The University of Adelaide, Adelaide, Australia.
BMC Pregnancy Childbirth. 2007 Aug 14;7:17. doi: 10.1186/1471-2393-7-17.
For women who have a caesarean section in their preceding pregnancy, two care policies for birth are considered standard: planned vaginal birth and planned elective repeat caesarean. Currently available information about the benefits and harms of both forms of care are derived from retrospective and prospective cohort studies. There have been no randomised trials, and recognising the deficiencies in the literature, there have been calls for methodologically rigorous studies to assess maternal and infant health outcomes associated with both care policies. The aims of our study are to assess in women with a previous caesarean birth, who are eligible in the subsequent pregnancy for a vaginal birth, whether a policy of planned vaginal birth after caesarean compared with a policy of planned repeat caesarean affects the risk of serious complications for the woman and her infant.
Multicentered patient preference study and a randomised clinical trial.
Women with a single prior caesarean presenting in their next pregnancy with a single, live fetus in cephalic presentation, who have reached 37 weeks gestation, and who do not have a contraindication to a planned VBAC. Trial Entry & Randomisation: Eligible women will be given an information sheet during pregnancy, and will be recruited to the study from 37 weeks gestation after an obstetrician has confirmed eligibility for a planned vaginal birth. Written informed consent will be obtained. Women who consent to the patient preference study will be allocated their preference for either planned VBAC or planned, elective repeat caesarean. Women who consent to the randomised trial will be randomly allocated to either the planned vaginal birth after caesarean or planned elective repeat caesarean group. Treatment Groups: Women in the planned vaginal birth group will await spontaneous onset of labour whilst appropriate. Women in the elective repeat caesarean group will have this scheduled for between 38 and 40 weeks. Primary Study Outcome: Serious adverse infant outcome (death or serious morbidity).
2314 women in the patient preference study to show a difference in adverse neonatal outcome from 1.6% to 3.6% (p = 0.05, 80% power).
对于前次妊娠为剖宫产的女性，两种标准的分娩护理策略被广泛认可：计划阴道分娩和计划择期再次剖宫产。目前关于这两种护理方式利弊的信息均来自回顾性和前瞻性队列研究。尚无随机试验，鉴于现有文献的不足，有人呼吁开展方法学严谨的研究以评估与这两种护理策略相关的母婴健康结局。我们研究的目的是评估前次剖宫产且本次妊娠适合阴道分娩的女性，剖宫产术后计划阴道分娩策略与计划再次剖宫产策略相比，是否会影响产妇及其婴儿发生严重并发症的风险。
多中心患者偏好研究及随机临床试验。
前次剖宫产一次，本次妊娠单活胎、头先露，孕周达37周，且无计划阴道试产禁忌证的女性。试验入组与随机分组：符合条件的女性在孕期会收到一份信息表，在产科医生确认其适合计划阴道分娩后，自孕37周起招募入组。将获得书面知情同意书。同意参加患者偏好研究的女性将被分配至其偏好的计划阴道试产或计划择期再次剖宫产组。同意参加随机试验的女性将被随机分配至剖宫产术后计划阴道分娩组或计划择期再次剖宫产组。治疗组：计划阴道分娩组的女性将等待自然临产。择期再次剖宫产组的女性将在38至40周安排手术。主要研究结局：严重不良婴儿结局（死亡或严重发病）。
患者偏好研究纳入2314名女性，以显示不良新生儿结局从1.6%至3.6%的差异（p = 0.05，检验效能80%）。
