Armed Forces Hospital Southern Region, Khamis Mushyat, Saudi Arabia.
Acta Obstet Gynecol Scand. 2013 Feb;92(2):215-22. doi: 10.1111/aogs.12017. Epub 2012 Dec 5.
To assess efficacy and tolerability of vaginal compared with intramuscular progesterone in reducing the rate of recurrent preterm birth before 34 weeks of gestation.
Prospective randomized study.
Obstetrics and Gynecology Department, Armed Forces Hospital Southern Region, Kingdom of Saudi Arabia.
Five-hundred and eighteen women with a prior history of preterm birth.
Women were randomized to receive either 90 mg of vaginal progesterone gel once daily or 250 mg of intramuscular progesterone weekly. Treatment began between 14 and 18 weeks of gestation and continued until 36 complete weeks of gestation, delivery or the occurrence of premature rupture of membranes.
The primary outcome measure was delivery before 34 weeks of gestation. The secondary outcome measures were PTB between 34 and 37 weeks of gestation and neonatal outcomes including birthweight, neonatal death, and the need for admission to the neonatal intensive care unit.
The baseline characteristics of the study participants were similar. Two-hundred and thirty-eight (94.1%) patients in the vaginal group and 226 (90.8%) patients in the intramuscular group were compliant with their medications. Vaginal progesterone was associated with a lower percentage of deliveries before 34 weeks of gestation than the intramuscular preparation (p= 0.02). This association was also observed at 28 and 32 weeks of gestation (p= 0.04). Adverse effects were reported in 14.1% of patients in the intramuscular group, but in only 7.5% of patients in the vaginal group (p= 0.017).
Vaginal progesterone was more effective than intramuscular progesterone for the prevention of preterm birth and had fewer adverse effects.
评估阴道用与肌内用黄体酮在降低 34 周前复发性早产率方面的疗效和耐受性。
前瞻性随机研究。
沙特阿拉伯王国南部地区武装部队医院妇产科。
518 例有早产史的妇女。
将妇女随机分为阴道用 90mg 黄体酮凝胶每日一次或肌内用 250mg 黄体酮每周一次。治疗从 14 至 18 孕周开始，持续至 36 周完整孕周、分娩或胎膜早破。
主要结局指标为 34 周前分娩。次要结局指标为 34 至 37 周早产和新生儿结局，包括出生体重、新生儿死亡和需要入住新生儿重症监护病房。
研究参与者的基线特征相似。阴道组 238 例（94.1%）和肌内组 226 例（90.8%）患者对其药物治疗的依从性良好。阴道用黄体酮与 34 周前分娩的比例低于肌内制剂（p=0.02）。这种关联在 28 和 32 孕周时也观察到（p=0.04）。肌内组有 14.1%的患者报告有不良反应，但阴道组只有 7.5%（p=0.017）。
阴道用黄体酮在预防早产方面比肌内用黄体酮更有效，且不良反应更少。
