Bigelow Catherine A, Factor Stephanie H, Miller Meredith, Weintraub Andrea, Stone Joanne
Department of Obstetrics and Gynecology, Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts.
Division of Infectious Disease, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.
Am J Perinatol. 2016 Mar;33(4):356-63. doi: 10.1055/s-0035-1564427. Epub 2015 Oct 13.
Preterm premature rupture of the membranes (PPROM) is spontaneous rupture of membranes before 37 weeks' gestation before the onset of labor. The standard of care is inpatient management with antibiotics and monitoring. Bed rest has not been shown to be beneficial in the setting of PPROM and has adverse maternal effects. We conducted a pilot randomized clinical trial (RCT) to determine the feasibility of recruitment for an RCT of this nature and obtain estimates of the frequency of maternal and neonatal outcomes.
Patients who were diagnosed with PPROM < 34 weeks gestational age were randomized to bed rest versus activity in a 1:1 ratio. Subjects in both groups wore pedometers and kept activity logs. Maternal demographic and obstetric data and neonatal outcomes were collected and compared between groups using chi-square and Fisher exact tests. Latency was evaluated with log-rank test and Kaplan-Meier analysis.
In this study, 36 women were enrolled and randomized; 1 patient withdrew. Complete data were available for 21 subjects. In univariable analysis, women in the activity group had a nonsignificantly shorter latency time than the bed rest group (median 6.0 vs. 8.5 days). Neonatal outcomes were similar between groups. Using log-rank sum analysis, neonates born to mothers in the activity group were more likely to develop necrotizing enterocolitis (NEC) than in the control group (24 vs. 0%, p = 0.05); this difference was not significant after false discovery rate correction (p = 0.80).
This is the first randomized controlled study to evaluate bed rest versus normal activity in the setting of PPROM < 34 weeks. This study demonstrates a nonsignificant increase in latency to delivery on bed rest and possible increase in NEC in the activity group; the mechanism remains unclear. We would recommend a larger RCT to better clarify these findings.
早产胎膜早破（PPROM）是指在妊娠37周前、临产前胎膜自发破裂。治疗标准是住院使用抗生素并进行监测。卧床休息在PPROM情况下未显示出益处，且对母亲有不良影响。我们进行了一项初步随机临床试验（RCT），以确定此类RCT招募的可行性，并获得母婴结局频率的估计值。
孕周<34周且被诊断为PPROM的患者按1:1比例随机分为卧床休息组和活动组。两组受试者均佩戴计步器并记录活动日志。收集产妇人口统计学和产科数据以及新生儿结局，并使用卡方检验和Fisher精确检验在组间进行比较。使用对数秩检验和Kaplan-Meier分析评估潜伏期。
本研究共纳入36名女性并进行随机分组；1名患者退出。21名受试者有完整数据。单因素分析显示，活动组女性的潜伏期比卧床休息组略短（中位数分别为6.0天和8.5天）。两组新生儿结局相似。使用对数秩和分析，活动组母亲所生新生儿发生坏死性小肠结肠炎（NEC）的可能性高于对照组（24% vs. 0%，p = 0.05）；在进行错误发现率校正后，这种差异无统计学意义（p = 0.80）。
这是第一项评估孕周<34周的PPROM患者卧床休息与正常活动的随机对照研究。该研究表明卧床休息组分娩潜伏期无显著增加，而活动组NEC可能增加；其机制尚不清楚。我们建议进行更大规模的RCT以更好地阐明这些发现。
