Facchinetti Fabio, Vergani Patrizia, Di Tommaso Mariarosaria, Marozio Luca, Acaia Barbara, Vicini Roberto, Pignatti Lucrezia, Locatelli Anna, Spitaleri Marina, Benedetto Chiara, Zaina Barbara, DʼAmico Roberto
Mother-Infant Department, Obstetrics and Gynecology Unit, and the Department of Diagnostic, Clinical and Public Health Medicine, Statistics Unit, University of Modena and Reggio Emilia, Modena, the Department of Medicine and Surgery, Obstetrics Gynecology Branch, University of Milano-Bicocca Health Science, and IRCCS Policlinico Hospital, Milan, the Health Science Department, Obstetrics and Gynecology Branch, University of Florence, Florence, and the Department of Surgical Sciences, Gynaecology and Obstetrics 1, University of Turin, Turin, Italy.
Obstet Gynecol. 2017 Jul;130(1):64-70. doi: 10.1097/AOG.0000000000002065.
To assess the efficacy of progestogens for maintenance tocolysis in women undelivered after their first preterm labor episode.
Women with singleton pregnancies between 22 0/7 and 31 6/7 weeks of gestation with arrested preterm labor and a cervical length 25 mm or less at hospital discharge were eligible. Patients with a previous preterm birth were excluded. In a randomized controlled trial conducted in five university hospitals, women were randomized to receive vaginal progesterone (200 mg per day) or intramuscular 17α-hydroxyprogesterone caproate (341 mg per week) or to an observation groups (control group). The primary outcome was the proportion of women with preterm birth at less than 37 weeks of gestation. A sample size of 160 per group (n=480) was planned to compare vaginal progesterone and 17α-hydroxyprogesterone caproate groups with those in the control group. The sample size estimation was based on the hypothesis that the risk of experiencing preterm birth in the control group would be 30% and that 17α-hydroxyprogesterone caproate or progesterone would decrease this risk to 15%. A P value of <.025 was defined as statistically significant. At planned interim analysis (n=254), the trial was stopped for futility.
Between July 2010 and June 2015, 257 women were eligible and 254 were subsequently randomly assigned to vaginal progesterone (n=86), 17α-hydroxyprogesterone caproate (n=87), or observation (n=81). Nineteen (8%) were excluded from the analysis because they either dropped out or information was missing, leaving 235 women available for analysis. Demographic characteristics were similar across groups. The preterm birth rate did not differ significantly between groups: 23% in the 17α-hydroxyprogesterone caproate group, 39% in the vaginal progesterone group, and 22% in the women in the control group (P=.949 for 17α-hydroxyprogesterone caproate compared with the women in the control group and P=.027 for vaginal progesterone compared with women in the control group).
The use of progestogens for maintenance tocolysis in women with a short cervix did not reduce the rate of preterm birth.
ClinicalTrials.gov, NCT01178788.
评估孕激素用于首次早产发作后未分娩女性维持性保胎治疗的疗效。
纳入妊娠22⁰/₇至31⁶/₇周的单胎妊娠女性，这些女性早产发作停止，且出院时宫颈长度为25mm或更短。既往有早产史的患者被排除。在五所大学医院进行的一项随机对照试验中，女性被随机分配接受阴道用黄体酮（每日200mg）或肌肉注射己酸17α-羟孕酮（每周341mg），或进入观察组（对照组）。主要结局是妊娠小于37周早产的女性比例。计划每组样本量为160例（n = 480），以比较阴道用黄体酮组和己酸17α-羟孕酮组与对照组。样本量估计基于以下假设：对照组早产风险为30%，己酸17α-羟孕酮或黄体酮可将此风险降至15%。P值<0.025被定义为具有统计学意义。在计划的中期分析（n = 254）时，该试验因无效而停止。
2010年7月至2015年6月期间，257名女性符合条件，随后254名被随机分配至阴道用黄体酮组（n = 86）、己酸17α-羟孕酮组（n = 87）或观察组（n = 81）。19名（8%）被排除在分析之外，因为她们退出研究或信息缺失，剩余235名女性可供分析。各组人口统计学特征相似。各组早产率无显著差异：己酸17α-羟孕酮组为23%，阴道用黄体酮组为39%，对照组女性为22%（己酸17α-羟孕酮组与对照组相比，P = 0.949；阴道用黄体酮组与对照组相比，P = 0.027）。
对于宫颈短的女性，使用孕激素进行维持性保胎治疗并不能降低早产率。
ClinicalTrials.gov，NCT01178788。
