Department of Obstetrics and Gynecology, The Ohio State University, Columbus, OH, USA.
Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, MI, USA.
J Matern Fetal Neonatal Med. 2022 Dec;35(25):8160-8168. doi: 10.1080/14767058.2021.1963705. Epub 2021 Aug 18.
We tested the hypothesis that administration of vaginal progesterone in women with arrested preterm labor would result in lower rates of preterm birth <37 weeks compared to placebo.
We performed a randomized, placebo-controlled trial comparing vaginal progesterone to placebo in women with arrested preterm labor. Our trial included women with a singleton or twin gestation at 24-33 weeks' gestation who presented with preterm labor with cervical dilation ≥1 centimeter but remained undelivered. Participants were randomized to receive vaginal progesterone 200 mg daily or an identical placebo. The primary outcome was preterm birth <37 weeks. We performed an updated systematic review and meta-analysis of clinical trials, including our results. We searched MEDLINE, EMBASE, CINHAL, Scopus, the Cochrane Database of Systematic Reviews, and ClinicalTrials.gov using the key terms to identify relevant trials. The risk of bias was appraised using the Cochrane risk-of-bias tool. Data were synthesized using random-effects models. Heterogeneity was assessed using Higgins .
The randomized trial was prematurely terminated due to slow recruitment. There were 18 women randomized to receive vaginal progesterone who had complete follow-up data and 18 women in the placebo group. The risk of preterm birth <37 weeks was not significantly different in the groups (RR 1.10, 95% CI 0.63-1.19). Secondary outcomes were also similar. Thirteen trials with 1658 women (835 in the vaginal progesterone and 823 in the control groups) were included in the meta-analysis. Risk of preterm birth <37 weeks was similar in women who received progesterone and those in the control group (pooled RR 1.06, 95% CI 0.83-1.35). Latency was significantly longer among women with arrested preterm labor who received vaginal progesterone (weighted mean difference: 9.2 d, 95% CI 3.2-15.1), but further analysis showed that prolonged latency was only observed in the subgroup of studies that were not placebo-controlled.
This randomized controlled trial and meta-analysis do not support the use of vaginal progesterone for the prevention of preterm birth in women who present in preterm labor.
我们检验了这样一个假设，即在出现早产停止的孕妇中使用阴道孕酮会降低<37 周的早产率，与安慰剂相比。
我们进行了一项随机、安慰剂对照试验，比较了阴道孕酮与安慰剂在出现早产停止的孕妇中的应用。我们的试验包括单胎或双胎妊娠在 24-33 周妊娠时出现早产，宫颈扩张≥1 厘米但仍未分娩的孕妇。参与者被随机分配接受阴道孕酮 200mg 每日或相同的安慰剂。主要结局是<37 周的早产。我们对临床试验进行了更新的系统评价和荟萃分析，包括我们的结果。我们使用关键词在 MEDLINE、EMBASE、CINHAL、Scopus、Cochrane 系统评价数据库和 ClinicalTrials.gov 上进行了搜索，以确定相关试验。使用 Cochrane 偏倚风险工具评估偏倚风险。使用随机效应模型综合数据。使用 Higgins 评估异质性。
由于招募缓慢，随机试验提前终止。有 18 名接受阴道孕酮治疗的妇女完成了完整的随访数据，18 名妇女在安慰剂组。两组早产<37 周的风险无显著差异（RR 1.10，95%CI 0.63-1.19）。次要结局也相似。共有 13 项试验纳入了 1658 名妇女（阴道孕酮组 835 名，对照组 823 名），进行了荟萃分析。接受孕酮治疗的妇女和对照组妇女的早产<37 周的风险相似（汇总 RR 1.06，95%CI 0.83-1.35）。接受阴道孕酮治疗的早产停止孕妇的潜伏期明显延长（加权平均差异：9.2d，95%CI 3.2-15.1），但进一步分析表明，潜伏期延长仅见于非安慰剂对照研究的亚组。
这项随机对照试验和荟萃分析不支持在出现早产停止的孕妇中使用阴道孕酮预防早产。
