Choudhary Manju, Suneja Amita, Vaid Neelam B, Guleria Kiran, Faridi M M A
Department of Obstetrics and Gynaecology, University College of Medical Sciences and Guru Tegh Bahadur Hospital, Delhi, India.
Department of Obstetrics and Gynaecology, University College of Medical Sciences and Guru Tegh Bahadur Hospital, Delhi, India.
Int J Gynaecol Obstet. 2014 Jul;126(1):60-3. doi: 10.1016/j.ijgo.2014.01.019. Epub 2014 Apr 3.
To evaluate the efficacy of maintenance therapy with oral micronized progesterone (OMP) for prolongation of pregnancy in cases of arrested preterm labor.
Ninety women at 24-34weeks of singleton pregnancy with intact membranes and arrested preterm labor were randomly allocated to receive OMP (n=45) or placebo (n=45) daily until 37weeks or delivery, whichever was earlier. Outcome parameters were compared using Student t test, χ(2) test, Fisher exact test, and log-rank χ(2) test.
OMP significantly prolonged the latency period (33.29±22.16 vs 23.07±15.42days; P=0.013). Log-rank analysis revealed a significant difference in mean time to delivery between the 2 groups (P=0.014). There were significantly fewer preterm births (33% vs 58%; P=0.034) and low birth weight neonates (37% vs 64%; P=0.017), and significantly higher mean birth weight (2.44±0.58 vs 2.14±0.47kg; P=0.009) in the OMP group. Perinatal outcomes and adverse effects were similar in the 2 groups.
Maintenance tocolysis with OMP significantly prolonged pregnancy and decreased the number of preterm births. Clinical Trial Registry of India: CTRI/2011/10/002043.
评估口服微粒化孕酮（OMP）维持治疗对延长早产停滞病例孕期的疗效。
90名单胎妊娠24 - 34周、胎膜完整且早产停滞的女性被随机分为两组，一组每日接受OMP治疗（n = 45），另一组接受安慰剂治疗（n = 45），直至孕37周或分娩，以先到者为准。使用学生t检验、χ²检验、Fisher精确检验和对数秩χ²检验比较结果参数。
OMP显著延长了潜伏期（33.29±22.16天 vs 23.07±15.42天；P = 0.013）。对数秩分析显示两组间平均分娩时间有显著差异（P = 0.014）。OMP组早产（33% vs 58%；P = 0.034）和低出生体重新生儿（37% vs 64%；P = 0.017）明显减少，平均出生体重显著更高（2.44±0.58 kg vs 2.14±0.47 kg；P = 0.009）。两组围产期结局和不良反应相似。
OMP维持保胎治疗显著延长了孕期并减少了早产数量。印度临床试验注册编号：CTRI/2011/10/002043。
