Rai Pushpanjali, Rajaram Shalini, Goel Neerja, Ayalur Gopalakrishnan Radhika, Agarwal Rachna, Mehta Sumita
Department of Obstetrics and Gynecology, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi, India.
Int J Gynaecol Obstet. 2009 Jan;104(1):40-3. doi: 10.1016/j.ijgo.2008.08.029. Epub 2008 Oct 16.
To evaluate oral micronized progesterone (OMP) to prevent preterm birth (PTB).
A randomized, double-blind, placebo-controlled trial of 150 women with at least one PTB who received 100 mg of OMP or placebo twice a day from recruitment (18-24 weeks) until 36 weeks or delivery.
PTB occurred in 29 (39.2%) women in the OMP group (n=74) compared with 44 (59.5%) in the control group (n=74, P=0.002). Mean gestational age at delivery was higher in the OMP group (36.1 vs 34.0 weeks, P<0.001). Fewer preterm births occurred between 28 and 31 weeks plus 6 days in the OMP group (RR 0.20; 95% CI, 0.05-0.73, P<0.001). Neonatal age at delivery (34 vs 32 weeks, P<0.001), birth weight (2400 vs 1890 g, P<0.001), NICU stay (>24 h, P<0.001), and Apgar scores (P<0.001) were more favorable in the OMP group, and fewer neonatal deaths occurred (3 vs 7, P=0.190).
OMP reduced the risk of PTB between 28 and 31 weeks plus 6 days, NICU admissions, and neonatal morbidity and mortality in high risk patients.
评估口服微粒化孕酮(OMP)预防早产(PTB)的效果。
一项随机、双盲、安慰剂对照试验,纳入150名有至少一次早产史的女性,自入组(18 - 24周)起至36周或分娩,每日两次给予100 mg OMP或安慰剂。
OMP组(n = 74)有29名(39.2%)女性发生早产,而对照组(n = 74)为44名(59.5%)(P = 0.002)。OMP组的平均分娩孕周更高(36.1周 vs 34.0周,P < 0.001)。OMP组在28至31周加6天之间发生的早产更少(RR 0.20;95% CI,0.05 - 0.73,P < 0.001)。OMP组的新生儿分娩时年龄(34周 vs 32周,P < 0.001)、出生体重(2400 g vs 1890 g,P < 0.001)、入住新生儿重症监护病房时间(> 24小时,P < 0.001)和阿氏评分(P < 0.001)更优,且新生儿死亡更少(3例 vs 7例,P = 0.190)。
OMP降低了高危患者在28至31周加6天之间的早产风险、新生儿重症监护病房入院率以及新生儿发病率和死亡率。