Optimizing Management of the Second Stage of Labor: Multicenter Randomized Trial

优化第二产程管理：多中心随机试验

• 批准号: 9093815
• 负责人: ALISON G CAHILL
• 金额: $ 171.08万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-18 至 2019-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9093815
• 关键词: Achievement; Acidosis; Acute; Address; Anatomy; Birth; Cervical; Cesarean section; Childbirth; Clinical; Clinical Management; Clinical assessments; Complex; Cost Savings; Data; Discipline of obstetrics; Effectiveness; Event; Fecal Incontinence; Fetus; Fever; Forcep; Frequencies; Hemorrhage; Hypoglycemia; Injury; Knowledge; Link; Measures; Meconium Aspiration; Meta-Analysis; Modernization; Morbidity - disease rate; Mothers; Muscle; Neonatal; Nulliparity; Observational Study; Operative Surgical Procedures; Outcome; Outcome Measure; Outcome Study; Patient Outcomes Assessments; Pelvic Floor Disorders; Pelvic floor dysfunction; Pelvic floor structure; Pelvis; Perception; Physiological; Pregnant Women; Public Health; Pulmonary Hypertension; Randomized; Randomized Clinical Trials; Reporting; Research; Respiratory distress; Risk; Rotation; Second Labor Stage; Symptoms; Techniques; Testing; Umbilical cord structure; Uncertainty; United States; Urinary Incontinence; Uterine Contraction; Vagina; Vaginal delivery procedure; Woman; high risk; improved; levator ani muscle; maternal morbidity; natural hypothermia; neonatal hypoxic-ischemic brain injury; neonatal morbidity; neonatal sepsis; neonate; newborn wet lung disease; pelvic organ prolapse; primary outcome; public health relevance; randomized trial; secondary outcome; sphincter ani muscle structure; virtual

DESCRIPTION (provided by applicant): Over three million pregnant women labor and give birth in the United States every year. Despite the frequency of this event, many aspects of labor management lack evidence. The second stage of labor, defined as the interval from complete cervical dilation through delivery of the fetus, is the most physiologically demanding period of labor for both the mother and the fetus. Despite the huge impact labor management can have on mode of delivery and neonatal and maternal morbidities, the optimal technique for managing maternal pushing during the second stage of labor is unknown. The two most common approaches involve either allowing for spontaneous descent (delayed pushing) or initiating pushing with uterine contractions once complete cervical dilation occurs (immediate pushing). Prior studies comparing these approaches reported results that are contradictory with regard to benefit and harm to the neonate and mother. Despite these data, delayed pushing gained wide spread use with a perception that it improves rates of vaginal delivery and reduces morbidities. By contrast, our recent meta-analysis demonstrated that among high-quality trials, delayed pushing did not improve the spontaneous vaginal delivery rate, but prolonged second stage duration. Notably, the largest trial evaluated outcome measures that are obsolete in contemporary obstetrics in the United States, such as use of mid-pelvic rotational forceps. Results of our large observational study indicated that selection to delayed pushing is associated with worse labor outcomes than immediate pushing. The lack of a modern, large, well- controlled, randomized clinical trial to address this question has led to uncertainty as to which technique for maternal pushing in the second stage of labor optimizes outcomes. In addition, effects of immediate versus delayed pushing on risk of maternal pelvic floor injury remain unknown. Given that approximately 11,000 women labor and deliver daily in the United States, there is an urgent need to fill this important clinical knowledge gap and provide high-quality evidence to inform contemporary obstetric management of the second stage of labor. We propose a large, multicenter, randomized clinical trial of immediate versus delayed pushing for nulliparous women in labor at term reaching complete cervical dilation. Our central hypothesis is that immediate pushing in the second stage of labor increases spontaneous vaginal delivery, shortens duration of the second stage, and reduces adverse neonatal and maternal outcomes in nulliparous women. We will pursue the following specific aims: 1) Assess the effectiveness of immediate pushing at complete cervical dilation on the rate of spontaneous vaginal delivery in nulliparous women (Primary Aim), 2) Determine the effect of immediate pushing on the rate of neonatal composite morbidity (Secondary Aim #1), and 3) Determine the impact of immediate versus delayed pushing on objective and subjective measures of maternal pelvic floor morbidity (Secondary Aim #2). We estimate that randomizing a total of 3184 women will provide adequate statistical power to detect meaningful differences in the primary and secondary outcomes.

描述（由申请人提供）：每年超过300万孕妇劳动并在美国分娩。尽管发生了这一事件的频率，但劳动管理的许多方面都缺乏证据。第二阶段的劳动阶段定义为从胎儿分娩到完全宫颈扩张的间隔，是母亲和胎儿的生理要求最高的劳动期。尽管劳动管理对分娩方式以及新生儿和母性的影响可能产生巨大影响，但在劳动力的第二阶段管理产妇推动的最佳技术尚不清楚。两种最常见的方法涉及允许自发下降（延迟推动），或者一旦发生完全宫颈扩张（即时推动），就可以用子宫收缩开始推动。比较这些方法的先前研究报告了对新生儿和母亲的利益和伤害矛盾的结果。尽管有这些数据，延迟推动获得了广泛的扩散使用，并认为它可以提高阴道分娩率并降低病态。相比之下，我们最近的荟萃分析表明，在高质量的试验中，延迟推动并不能提高自发的阴道递送率，而是延长了第二阶段的持续时间。值得注意的是，最大的试验评估了美国当代妇产科中过时的结果指标，例如使用中骨旋转镊子。我们大型观察性研究的结果表明，延迟推动的选择与劳动结果差，而不是立即推动。缺乏现代，大型，控制良好的随机临床试验来解决这个问题，这导致了在第二​​阶段劳动力优化的孕产妇推动技术的不确定性。此外，直接与延迟推动母体骨盆底损伤风险的影响尚不清楚。鉴于在美国大约有11,000名妇女劳动并每天分娩，因此迫切需要填补这一重要的临床知识差距，并提供高质量的证据，以告知当代劳动阶段的当代产科管理。我们提出了一项大型，多中心，随机的临床试验，即立即与延迟推动劳动力的无效妇女在学期达到完全宫颈扩张。我们的中心假设是，立即在劳动力的第二阶段推动会增加自发的阴道分娩，缩短第二阶段的持续时间，并减少无效妇女的不良新生儿和孕妇结果。我们将追求以下具体目的：1）评估无效妇女自发性传递速率的立即推动的有效性（主要目的），2）确定立即推动新生儿复合发病率的速率的影响（次要目标＃1），以及二级临时型号的影响，并确定对临时性和主体的影响，并确定对型号的影响。目标＃2）。我们估计，将总共3184名妇女随机进行随机，将提供足够的统计能力，以检测主要和次要结果的有意义差异。