Placental Related Diseases Research Unit, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Rama IV Road, Pathumwan, Bangkok, 10330, Thailand.
Matern Child Health J. 2021 Jul;25(7):1102-1109. doi: 10.1007/s10995-021-03153-z. Epub 2021 Apr 26.
The primary objective in this study was to evaluate the effects of vaginal progesterone supplementation for the prolongation of the latency period in preterm labor. The secondary objectives were to evaluate gestational age at delivery, rates of preterm birth less than 34 and 37 weeks, obstetric outcomes, maternal compliance with medication use, and side effects.
A randomized controlled, unblinded trial was performed. Ninety women with preterm labor occurring at 24 to 34 weeks were either randomized to a vaginal progesterone group (44 women) receiving tocolytic and antenatal corticosteroids treatment combined with vaginal micronized progesterone (400 mg everyday) or to the no-progesterone group (46 women) receiving tocolytic and antenatal corticosteroids treatment only.
Latency periods were more prolonged in the vaginal progesterone group than in the no-progesterone group (32.8 ± 18.7 vs. 25.8 ± 22.7 days, p = 0.045). Gestational age at delivery in the vaginal progesterone group was also higher than in the no-progesterone group (37 vs. 35 weeks, p = 0.027). There were significant reduction rates of preterm birth less than 34 weeks (13.6% vs. 39.1%, p = 0.012), low birth weight (29.5% vs. 50%, p = 0.048), neonatal respiratory distress syndrome (13.6% vs. 37%, p = 0.021), and neonatal intensive care unit admission (6.8% vs. 28.3%, p = 0.017).
Combined treatment with vaginal progesterone 400 mg could prolong the latency period in preterm labor when compared with no progesterone.
本研究的主要目的是评估阴道用黄体酮补充剂对延长早产潜伏期的效果。次要目的是评估分娩时的胎龄、小于 34 周和 37 周的早产率、产科结局、产妇对药物使用的依从性以及副作用。
进行了一项随机对照、非盲试验。90 例在 24 至 34 周发生早产的妇女被随机分为阴道用黄体酮组（44 例），接受保胎药物和产前皮质激素治疗，同时阴道给予米索前列醇（每天 400mg）；或无黄体酮组（46 例），仅接受保胎药物和产前皮质激素治疗。
阴道用黄体酮组的潜伏期比无黄体酮组更长（32.8±18.7 与 25.8±22.7 天，p=0.045）。阴道用黄体酮组的分娩时胎龄也高于无黄体酮组（37 与 35 周，p=0.027）。小于 34 周的早产发生率显著降低（13.6%与 39.1%，p=0.012）、低出生体重（29.5%与 50%，p=0.048）、新生儿呼吸窘迫综合征（13.6%与 37%，p=0.021）和新生儿重症监护病房入院率（6.8%与 28.3%，p=0.017）也降低。
与无黄体酮相比，阴道用黄体酮 400mg 联合治疗可延长早产的潜伏期。
