Otsuka Naoki, Imai Kenji, Tano Sho, Matsuo Seiko, Ushida Takafumi, Nomoto Masataka, Iitani Yukako, Ishi Mika, Kawai Yosuke, Furui Toshimitsu, Kajiyama Hiroaki, Kotani Tomomi
Division of Obstetrics and Gynecology, Ogaki Municipal Hospital, Gifu, Japan.
Department of Obstetrics and Gynecology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
JMA J. 2024 Oct 15;7(4):582-589. doi: 10.31662/jmaj.2024-0036. Epub 2024 Sep 20.
Few studies have explored the preventive efficacy of vaginal progesterone (VD) treatment for preterm delivery (PTD) in Japanese clinical practice. In this study, the efficacy of the VD treatment in pregnant women with a short cervix (sCX) diagnosed after 24 weeks is evaluated, focusing on perinatal outcomes.
A retrospective historical cohort study. Clinical data of 273 singleton women hospitalized for preventing PTD were extracted. Inclusion criteria are diagnosed sCX at 24-33 weeks. We excluded women with factors including treatment start before 24 weeks, medically induced PTD, PTD on admission day, and fetal demise. Consequently, logistic regression analyses were conducted on data from 79 women during Period 1 (November 2015 to March 2018, using prolonged intravenous ritodrine hydrochloride) and 82 women during Period 2 (August 2018 to August 2022, implementing VD treatment), adjusting maternal age, parity, body mass index, gestational age, cervical length, and histological chorioamnionitis. The primary outcomes involved PTD <37 and <34 weeks and neonatal intensive care unit admission. Secondary outcomes included the interval from the diagnosis of sCX to delivery <14 and <28 days, infant intubation, and surfactant administration. Since VD use is off-label in Japan, we obtained written informed consent prior to treatment.
VD treatment (Period 2) significantly decreased the incidence of PTD (birth < 37 weeks) (adjusted odds ratios [ORs] 0.43, 95% confidence intervals [CIs] 0.19-0.96), impending delivery within 14 and 28 days after confirming sCX (adjusted OR 0.12, 95% CI 0.06-0.72; adjusted OR 0.25, 95% CI 0.09-0.74, respectively), and neonatal intubation rate (adjusted OR 0.17, 95% CI 0.04-0.75).
The VD treatment can prevent PTD in asymptomatic women with sCX diagnosed after 24 weeks of gestation. Although further validation is warranted, these findings may contribute to expanding the use of VD treatment in Japanese clinical practice.
在日本临床实践中，很少有研究探讨阴道用黄体酮（VD）治疗对早产（PTD）的预防效果。在本研究中，评估了VD治疗对24周后诊断为宫颈短（sCX）的孕妇的疗效，重点关注围产期结局。
一项回顾性历史队列研究。提取了273名单胎住院预防早产的妇女的临床数据。纳入标准为在24至33周时诊断为sCX。我们排除了具有以下因素的妇女：24周前开始治疗、医源性早产、入院当天早产以及胎儿死亡。因此，对第1阶段（2015年11月至2018年3月，使用延长静脉注射盐酸利托君）的79名妇女和第2阶段（2018年8月至2022年8月，实施VD治疗）的82名妇女的数据进行了逻辑回归分析，调整了产妇年龄、产次、体重指数、孕周、宫颈长度和组织学绒毛膜羊膜炎。主要结局包括孕周<37周和<34周的早产以及新生儿重症监护病房入院。次要结局包括从诊断sCX到分娩<14天和<28天的间隔、婴儿插管和表面活性剂给药。由于在日本VD的使用属于超说明书用药，我们在治疗前获得了书面知情同意。
VD治疗（第2阶段）显著降低了早产（出生孕周<37周）的发生率（调整后的优势比[ORs]为0.43，95%置信区间[CIs]为0.19 - 0.96）、确认sCX后14天和28天内即将分娩的发生率（调整后的OR分别为0.12，95%CI为0.06 - 0.72；调整后的OR为0.25，95%CI为0.09 - 0.74）以及新生儿插管率（调整后的OR为0.17，95%CI为0.04 - 0.75）。
VD治疗可预防妊娠24周后诊断为sCX的无症状妇女发生早产。尽管需要进一步验证，但这些发现可能有助于在日本临床实践中扩大VD治疗的应用。
