Department of Obstetrics, Gynecology and Reproductive Medicine, CHULN - Hospital de Santa Maria, Lisboa, Portugal.
Department of Obstetrics, Gynecology and Reproductive Medicine, CHULN - Hospital de Santa Maria, Lisboa, Portugal.
Eur J Obstet Gynecol Reprod Biol. 2019 Sep;240:325-329. doi: 10.1016/j.ejogrb.2019.07.037. Epub 2019 Jul 30.
To assess the impact of bed rest on maternal and neonatal outcomes in pregnancies complicated by preterm premature rupture of the membranes (PPROM), enabling proper sample size calculation for a powered randomized controlled trial (RCT).
We conducted a pilot unblinded randomized controlled trial with a 1:1 allocation ratio (complete bed rest vs activity restriction groups) on singleton pregnancies complicated by PPROM at 24 + 0-33 + 6 weeks. Maternal and neonatal data were compared between groups with an intent-to-treat analysis. The primary outcomes were the latency time to delivery and the incidence of chorioamnionitis. The trial was conducted in a tertiary center of the Portuguese national healthcare system. Patients received standard antibiotic prophylaxis. Delivery was planned for the 34th week of gestation, except in cases of spontaneous labor or another complication.
Thirty-two cases were randomized and analyzed, 14 in the complete bed rest group and 18 in the activity restriction group. The median gestational age at PPROM was 30 vs 29 weeks (p = 0.82). In the complete bed rest group, the incidence of chorioamnionitis was nonsignificantly lower (14% vs 28%, p = 0.43). Median latency time was 11.5 days (95% CI, 2-20) in the complete bed rest group and 7.5 days (95% CI, 3-11) in the activity restriction group, lacking statistical significance on univariate (p = 0.6) and survival analyses (log-rank test, p = 0.75). No difference was found between groups regarding indication or type of delivery and maternal or neonatal morbidity. The median gestational age at delivery was 32 weeks for both groups (p = 0.94). A sample size of 2052 participants was calculated for a powered RCT, considering latency as the primary outcome.
In this pilot trial, bed rest did not increase latency to delivery and did not improve maternal or neonatal morbidity in the setting of PPROM at 24 + 0-33 + 6 weeks. A sample size calculation is now available for a powered RCT.
评估卧床休息对患有早产胎膜早破（PPROM）的孕妇母婴结局的影响，以便为一项有影响力的随机对照试验（RCT）进行适当的样本量计算。
我们进行了一项试点非盲随机对照试验，采用 1:1 分配比（完全卧床休息与活动限制组），纳入妊娠 24+0-33+6 周时患有 PPROM 的单胎妊娠。采用意向治疗分析比较两组的母婴数据。主要结局是分娩潜伏期和绒毛膜羊膜炎的发生率。该试验在葡萄牙国家医疗保健系统的一家三级中心进行。患者接受标准抗生素预防。除非出现自发性分娩或其他并发症，否则计划在第 34 孕周进行分娩。
32 例患者被随机分配并进行了分析，其中 14 例分入完全卧床休息组，18 例分入活动限制组。PPROM 的中位孕龄为 30 周与 29 周（p=0.82）。在完全卧床休息组，绒毛膜羊膜炎的发生率虽较低但无统计学意义（14%比 28%，p=0.43）。完全卧床休息组的中位潜伏期为 11.5 天（95%CI，2-20），活动限制组为 7.5 天（95%CI，3-11），单变量分析（p=0.6）和生存分析（对数秩检验，p=0.75）均无统计学意义。两组在分娩指征或类型、母婴发病率或新生儿发病率方面无差异。两组的中位分娩孕周均为 32 周（p=0.94）。考虑到潜伏期为主要结局，该研究计算出一项有影响力的 RCT 需要 2052 名参与者的样本量。
在这项试点试验中，在妊娠 24+0-33+6 周时患有 PPROM 的情况下，卧床休息并未延长分娩潜伏期，也未改善母婴发病率。现在可以为一项有影响力的 RCT 进行样本量计算。
