Cunningham F Gary, Bangdiwala Shrikant I, Brown Sarah S, Dean Thomas Michael, Frederiksen Marilynn, Rowland Hogue Carol J, King Tekoa, Spencer Lukacz Emily, McCullough Laurence B, Nicholson Wanda, Petit Nancy Frances, Probstfield Jeffrey Lynn, Viguera Adele C, Wong Cynthia A, Zimmet Sheila Cohen
Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, USA.
NIH Consens State Sci Statements. 2010 Mar 10;27(3):1-42.
To provide health care providers, patients, and the general public with a responsible assessment of currently available data on vaginal birth after cesarean (VBAC).
A non-DHHS, nonadvocate 15-member panel representing the fields of obstetrics and gynecology, urogynecology, maternal and fetal medicine, pediatrics, midwifery, clinical pharmacology, medical ethics, internal medicine, family medicine, perinatal and reproductive psychiatry, anesthesiology, nursing, biostatistics, epidemiology, health care regulation, risk management, and a public representative, and a public representative. In addition, 21 experts from pertinent fields presented data to the panel and conference audience.
Presentations by experts and a systematic review of the literature prepared by the Oregon Evidence-based Practice Center, through the Agency for Healthcare Research and Quality. Scientific evidence was given precedence over anecdotal experience.
The panel drafted its statement based on scientific evidence presented in open forum and on published scientific literature. The draft statement was presented on the final day of the conference and circulated to the audience for comment. The panel released a revised statement later that day at http://consensus.nih.gov. This statement is an independent report of the panel and is not a policy statement of the NIH or the Federal Government.
Given the available evidence, trial of labor is a reasonable option for many pregnant women with one prior low transverse uterine incision. The data reviewed in this report show that both trial of labor and elective repeat cesarean delivery for a pregnant woman with one prior transverse uterine incision have important risks and benefits and that these risks and benefits differ for the woman and her fetus. This poses a profound ethical dilemma for the woman, as well as her caregivers, because benefit for the woman may come at the price of increased risk for the fetus and vice versa. This conundrum is worsened by the general paucity of high-level evidence about both medical and nonmedical factors, which prevents the precise quantification of risks and benefits that might help to make an informed decision about trial of labor compared with elective repeat cesarean delivery. The panel was mindful of these clinical and ethical uncertainties in making the following conclusions and recommendations. One of the panel’s major goals is to support pregnant women with one prior transverse uterine incision to make informed decisions about trial of labor compared with elective repeat cesarean delivery. The panel recommends that clinicians and other maternity care providers use the responses to the six questions, especially questions 3 and 4, to incorporate an evidence-based approach into the decisionmaking process. Information, including risk assessment, should be shared with the woman at a level and pace that she can understand. When trial of labor and elective repeat cesarean delivery are medically equivalent options, a shared decisionmaking process should be adopted and, whenever possible, the woman’s preference should be honored. The panel is concerned about the barriers that women face in gaining access to clinicians and facilities that are able and willing to offer trial of labor. Given the low level of evidence for the requirement for "immediately available" surgical and anesthesia personnel in current guidelines, the panel recommends that the American College of Obstetricians and Gynecologists and the American Society of Anesthesiologists reassess this requirement with specific reference to other obstetric complications of comparable risk, risk stratification, and in light of limited physician and nursing resources. Healthcare organizations, physicians, and other clinicians should consider making public their trial of labor policies and VBAC rates, as well as their plans for responding to obstetric emergencies. The panel recommends that hospitals, maternity care providers, healthcare and professional liability insurers, consumers, and policymakers collaborate on the development of integrated services that could mitigate or even eliminate current barriers to trial of labor. The panel is concerned that medical-legal considerations add to, and in many instances exacerbate, these barriers to trial of labor. Policymakers, providers, and other stakeholders must collaborate in developing and implementing appropriate strategies to mitigate the chilling effect the medical-legal environment has on access to care. High-quality research is needed in many areas. The panel has identified areas that need attention in response to question 6. Research in these areas should be given appropriate priority and should be adequately funded--especially studies that would help to characterize more precisely the short-term and long-term maternal, fetal, and neonatal outcomes of trial of labor and elective repeat cesarean delivery.
为医疗保健提供者、患者及公众提供关于剖宫产术后阴道分娩(VBAC)现有数据的负责任评估。
一个由15名成员组成的非美国卫生与公众服务部(DHHS)、无利益偏向的小组,成员代表妇产科、女性盆底重建外科学、母胎医学、儿科学、助产术、临床药理学、医学伦理学、内科学、家庭医学、围产期及生殖精神病学、麻醉学、护理学、生物统计学、流行病学、医疗保健监管、风险管理等领域,以及一名公众代表。此外,来自相关领域的21位专家向小组及会议听众提供了数据。
专家的报告以及俄勒冈循证实践中心通过医疗保健研究与质量局编制的文献系统综述。科学证据优先于轶事经验。
小组根据公开论坛上呈现的科学证据及已发表的科学文献起草声明。声明草案在会议最后一天公布,并分发给听众征求意见。小组当天晚些时候在http://consensus.nih.gov上发布了修订后的声明。本声明是小组的独立报告,并非美国国立卫生研究院(NIH)或联邦政府的政策声明。
鉴于现有证据,对于许多有一次既往子宫下段横切口的孕妇而言,试产是一个合理的选择。本报告中所审查的数据表明,对于有一次既往子宫横切口的孕妇,试产和择期再次剖宫产均有重要的风险和益处,而且这些风险和益处对于孕妇及其胎儿而言有所不同。这给孕妇及其护理人员带来了深刻的伦理困境,因为对孕妇有益可能是以增加胎儿风险为代价,反之亦然。由于关于医学和非医学因素的高级别证据普遍匮乏,这一难题更加棘手,因为这妨碍了对风险和益处进行精确量化,而精确量化有助于在试产与择期再次剖宫产之间做出明智的决策。小组在得出以下结论和建议时,考虑到了这些临床和伦理上的不确定性。小组的主要目标之一是支持有一次既往子宫横切口的孕妇在试产与择期再次剖宫产之间做出明智的决策。小组建议临床医生和其他产科护理人员利用对六个问题的回答,尤其是问题3和问题4,将循证方法纳入决策过程。应按照孕妇能够理解的水平和速度,与她分享包括风险评估在内的信息。当试产和择期再次剖宫产在医学上是等效选择时,应采用共同决策过程,并且只要有可能,就应尊重孕妇的偏好。小组关注孕妇在获得能够且愿意提供试产的临床医生和机构方面所面临的障碍。鉴于当前指南中关于“随时可用”的手术和麻醉人员要求证据水平较低,小组建议美国妇产科医师学会和美国麻醉医师协会重新评估这一要求,具体参考其他具有类似风险、风险分层的产科并发症,并考虑到有限的医生和护理资源。医疗保健机构、医生和其他临床医生应考虑公布他们的试产政策、VBAC率以及应对产科紧急情况的计划。小组建议医院、产科护理人员、医疗保健及专业责任保险公司、消费者和政策制定者合作开发综合服务,以减轻甚至消除当前试产的障碍。小组担心医疗法律方面的考虑因素增加了,并且在许多情况下加剧了试产的这些障碍。政策制定者、提供者和其他利益相关者必须合作制定和实施适当的策略,以减轻医疗法律环境对获得医疗服务的不利影响。许多领域都需要高质量的研究。小组已确定了针对问题6需要关注的领域。这些领域的研究应得到适当的优先考虑并获得充足的资金——尤其是有助于更精确地描述试产和择期再次剖宫产的短期和长期母体、胎儿及新生儿结局的研究。