Royal Prince Alfred Hospital, Camperdown, Australia.
Maternal-fetal medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.
J Matern Fetal Neonatal Med. 2022 Mar;35(6):1134-1140. doi: 10.1080/14767058.2020.1743662. Epub 2020 Mar 26.
The efficacy of maintenance tocolytic therapy after successful arrest of preterm labor remains controversial. The purpose of this study was to evaluate the efficacy of 400 mg of daily vaginal progesterone (cyclogest) after successful parenteral tocolysis to increase latency period and improvement of neonatal outcomes in women with threatened preterm labor.
In this randomized, double-blind, placebo-controlled trial, 85 participants were randomly allocated to either 400 mg daily of vaginal progesterone ( = 45) or placebo ( = 40) until 34 weeks of gestation. The primary outcomes were the time until delivery (latency period) and cervical length after 1 week of treatment. Secondary outcome were GA on delivery, type of delivery, incidence of low birth weight, perinatal morbidity and mortality.
Longer mean latency until delivery (53.6 ± 16.8 versus 34.5 ± 12.9) days = .0001; longer mean of gestational age on delivery (37.5 ± 2.2 versus 34.2 ± 2.1) weeks = .0001; cervical length after 1 week of treatment (27.5 ± 5.5 versus 20.7 ± 3.1) mm = .0001; low birth weight 12 (29.3%) versus 19 (57.6%) = .01; and NICU admission 9 (22%) versus 15 (45.5%), were significantly different between the two groups. No significant differences were found between neonatal death 1 (2.4%) versus 2 (6.1%), = .43; RDS 5 (12.2%) versus 8 (24.2%), = .17; and need to mechanical ventilator 2 (5.4%) versus 6 (18.2%) = .136, for the progesterone and placebo groups, respectively.
Daily administration of 400 mg vaginal progesterone after successful parenteral tocolysis may increase latency preceding delivery and improves cervical shortening and neonatal outcome in women with preterm labor. Further confirmatory studies are warranted.
成功抑制早产临产（PTB）后维持保胎治疗的疗效仍存在争议。本研究旨在评估成功接受保胎治疗后，每日阴道给予 400mg 黄体酮（cyclogest）能否延长潜伏期，并改善有早产临产威胁的女性新生儿结局。
在这项随机、双盲、安慰剂对照试验中，85 名参与者被随机分配至每日阴道给予 400mg 黄体酮（n=45）或安慰剂（n=40），直至妊娠 34 周。主要结局是分娩前的时间（潜伏期）和治疗 1 周后的宫颈长度。次要结局是分娩时的 GA、分娩方式、低出生体重发生率、围产期发病率和死亡率。
更长的平均分娩前潜伏期（53.6±16.8 与 34.5±12.9）天 = .0001；更长的平均分娩时 GA（37.5±2.2 与 34.2±2.1）周 = .0001；治疗 1 周后的宫颈长度（27.5±5.5 与 20.7±3.1）mm = .0001；低出生体重 12（29.3%）与 19（57.6%） = .01；NICU 住院 9（22%）与 15（45.5%），两组之间差异有统计学意义。两组新生儿死亡率 1（2.4%）与 2（6.1%）、呼吸窘迫综合征（RDS）5（12.2%）与 8（24.2%）、需要机械通气 2（5.4%）与 6（18.2%）的差异均无统计学意义，分别为 = .43； = .17； = .136。
成功接受保胎治疗后，每日阴道给予 400mg 黄体酮可能会延长分娩前潜伏期，并改善早产临产孕妇的宫颈缩短和新生儿结局。需要进一步的证实性研究。
