Departments of Obstetrics and Gynecology, Stanford University, Stanford, California, Northwestern University, Chicago, Illinois, University of Alabama at Birmingham, Birmingham, Alabama, University of Utah Health Sciences Center, Salt Lake City, Utah, Columbia University, New York, New York, Brown University, Providence, Rhode Island, University of Texas Medical Branch, Galveston, Texas, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas, The Ohio State University, Columbus, Ohio, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, University of Texas Southwestern Medical Center, Dallas, Texas, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, Colorado, University of Pennsylvania, Philadelphia, Pennsylvania, Duke University, Durham, North Carolina, University of Pittsburgh, Pittsburgh, Pennsylvania, Washington University in St. Louis, St. Louis, Missouri; the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.
Obstet Gynecol. 2020 Oct;136(4):692-697. doi: 10.1097/AOG.0000000000004055.
To evaluate characteristics associated with adverse outcomes in low-risk nulliparous women randomized to elective labor induction at 39 weeks of gestation or expectant management.
We conducted a secondary analysis of women randomized during the 38th week to induction at 39 weeks of gestation or expectant management. Deliveries before 39 weeks of gestation and those not adherent to study protocol or with fetal anomalies were excluded. A composite of adverse outcomes (perinatal death or severe neonatal complications), third- or fourth-degree lacerations, and postpartum hemorrhage were evaluated. Log binomial regression models estimated relative risks and 95% CIs for associations of outcomes with patient characteristics including randomly assigned treatment group. Interactions between patient characteristics and treatment group were tested.
Of 6,096 women with outcome data, 5,007 (82.1%) met criteria for inclusion in this analysis. Frequency of the perinatal composite was 252 (5.0%), 166 (3.3%) for third- or fourth-degree perineal laceration, and 237 (4.7%) for postpartum hemorrhage. In multivariable analysis, intended labor induction at 39 weeks of gestation was associated with a reduced perinatal composite outcome (4.1% vs 6.0%; adjusted relative risk [aRR] 0.71; 95% CI 0.55-0.90), whereas increasing body mass index (BMI) was associated with an increased perinatal composite outcome (aRR 1.04/unit increase; 95% CI 1.02-1.05). Decreased risk of third- or fourth-degree perineal laceration was observed with increasing BMI (aRR 0.96/unit increase; 95% CI 0.93-0.98) and in Black women compared with White women (1.2% vs 3.9%; aRR 0.34; 95% CI 0.19-0.60). Increased risk of postpartum hemorrhage was observed in Hispanic women compared with White women (6.3% vs 4.0%; aRR 1.64; 95% CI 1.18-2.29). Patient characteristics associated with adverse outcomes were similar between treatment groups (P for interaction >.05).
Compared with expectant management, intended induction at 39 weeks of gestation was associated with reduced risk of adverse perinatal outcome. Patient characteristics associated with adverse outcomes were few and similar between groups.
ClinicalTrials.gov, NCT01990612.
评估在 39 孕周随机选择选择性引产或期待管理的低危初产妇不良结局的相关特征。
我们对第 38 周随机分为 39 孕周引产或期待管理的产妇进行了二次分析。排除了 39 孕周前分娩和未遵守研究方案或有胎儿异常的产妇。评估了不良结局（围产儿死亡或严重新生儿并发症）、三度或四度会阴裂伤和产后出血的复合结局。使用对数二项式回归模型估计了结局与患者特征（包括随机分配的治疗组）之间的关联的相对风险和 95%置信区间。测试了患者特征和治疗组之间的交互作用。
在有结局数据的 6096 名妇女中，5007 名（82.1%）符合本分析的纳入标准。围产儿复合结局的发生率为 252 例（5.0%），三度或四度会阴裂伤 166 例（3.3%），产后出血 237 例（4.7%）。多变量分析显示，39 孕周计划引产与围产儿复合结局降低相关（4.1%比 6.0%；调整后的相对风险[aRR]0.71；95%置信区间 0.55-0.90），而体重指数（BMI）增加与围产儿复合结局增加相关（aRR 每增加 1 单位 1.04；95%置信区间 1.02-1.05）。BMI 增加与三度或四度会阴裂伤风险降低相关（aRR 每增加 1 单位 0.96；95%置信区间 0.93-0.98），与白人妇女相比，黑人妇女发生三度或四度会阴裂伤的风险降低（1.2%比 3.9%；aRR 0.34；95%置信区间 0.19-0.60）。与白人妇女相比，西班牙裔妇女产后出血的风险增加（6.3%比 4.0%；aRR 1.64；95%置信区间 1.18-2.29）。两组之间不良结局相关的患者特征相似（P 交互作用>0.05）。
与期待管理相比，39 孕周计划引产与不良围产儿结局风险降低相关。与不良结局相关的患者特征较少且在组间相似。
ClinicalTrials.gov，NCT01990612。
