Vaginal progesterone is associated with a decrease in risk for early preterm birth and improved neonatal outcome in women with a short cervix: a secondary analysis from a randomized, double-blind, placebo-controlled trial

被引:180
作者
DeFranco, E. A.
O'Brien, J. M.
Adair, C. D.
Lewis, D. F.
Hall, D. R.
Fusey, S.
Soma-Pillay, P.
Porter, K.
How, H.
Schakis, R.
Eller, D.
Trivedi, Y.
Vanburen, G.
Khandelwal, M.
Trofatter, K.
Vidyadhari, D.
Vijayaraghavan, J.
Weeks, J.
Dattel, B.
Newton, E.
Chazotte, C.
Valenzuela, G.
Calda, P.
Bsharat, M.
Creasy, G. W.
机构
[1] Washington Univ, Sch Med, Dept Obstet & Gynecol, St Louis, MO 63110 USA
[2] Washington Univ, Sch Med, Ctr Preterm Birth Res, St Louis, MO 63110 USA
[3] Cent Baptist Hosp, Perinatal Diagnost Ctr, Lexington, KY USA
[4] Univ Tennessee, Coll Med, Chattanooga, TN USA
[5] Louisiana State Univ, Hlth Sci Ctr, Dept Obstet & Gynecol, Shreveport, LA 71105 USA
[6] Univ Stellenbosch, Dept Obstet & Gynaecol, ZA-7505 Tygerberg, South Africa
[7] Tygerberg Hosp, Dept Obstet & Gynaecol, Tygerberg, South Africa
[8] Govt Med Coll, Dept Obstet & Gynaecol, Nagpur, Maharashtra, India
[9] Univ Pretoria, Dept Obstet & Gynaecol, ZA-0002 Pretoria, South Africa
[10] Univ S Alabama, Mobile, AL 36688 USA
[11] Univ Cincinnati, Cincinnati, OH USA
[12] Univ Witwatersrand, Chris Hani Baragwanath Hosp, Soweto, South Africa
[13] Maternal Fetal Specialists, Atlanta, GA USA
[14] Univ Hosp Case Med Ctr, Cleveland, OH USA
[15] Univ Med & Dent New Jersey, Cooper Hosp, Camden, NJ 08103 USA
[16] Univ Med Grp, Greenville, SC USA
[17] Sri Ramchandra Hosp, Madras, Tamil Nadu, India
[18] Norton Healthcare, Louisville, KY USA
[19] Eastern Virginia Med Sch, Dept Obstet & Gynecol, Norfolk, VA 23501 USA
[20] E Carolina Univ, Brody Sch Med, Greenville, NC USA
[21] Montefiore Med Ctr, Albert Einstein Coll Med, Bronx, NY 10467 USA
[22] Arrowhead Reg Med Ctr, Colton, CA USA
[23] Charles Univ Prague, Sch Med 1, Dept Obstet & Gynaecol, Prague, Czech Republic
[24] Quintiles Biostat, Overland Pk, KS USA
[25] Columbia Labs Inc, Livingston, NJ USA
关键词
pregnancy; prematurity; preterm birth; progesterone; short cervix; PREVENTION; DELIVERY; LENGTH; PREDICTION; PREGNANCY; EFFICACY; HISTORY; LABOR;
D O I
10.1002/uog.5159
中图分类号
O42 [声学];
学科分类号
070206 ; 082403 ;
摘要
Objective To investigate the efficacy of vaginal progesterone to prevent early preterm birth in women with sonographic evidence of a short cervical length in the midtrimester. Methods This was a planned, but modified, secondary analysis of our multinational, multicenter, randomized, placebo-controlled trial, in which women were randomized between 18 + 0 and 22 + 6 weeks of gestation to receive daily treatment with 90 mg of vaginal progesterone gel or placebo. Cervical length was measured with transvaginal ultrasound at enrollment and at 28 weeks of gestation. Treatment continued until either delivery, 37 weeks of gestation or development of preterm rupture of membranes. Maternal and neonatal outcomes were evaluated for the subset of all randomized women with cervical length < 28 mm at enrollment. The primary outcome was preterm birth at <= 32 weeks. Results A cervical length < 28 mm was identified in 46 randomized women: 19 of 313 who received progesterone and 27 of 307 who received the placebo. Baseline characteristics of the two groups were similar. In women with a cervical length < 28 mm, the rate of preterm birth at <= 32 weeks was significantly lower for those receiving progesterone than it was for those receiving the placebo (0% vs. 29.6%, P = 0.014). With progesterone, there were fewer admissions into the neonatal intensive care unit (NICU; 15.8% vs. 51.9%, P = 0.016) and shorter NICU stays (1.1 vs. 16.5 days, P = 0.013). There was also a trend toward a decreased rate of neonatal respiratory distress syndrome (5.3% vs. 29.6%, P = 0.060). Conclusion Vaginal progesterone may reduce the rate of early preterm birth and improve neonatal outcome in women with a short sonographic cervical length. Copyright (C) 2007 ISUOG. Published by John Wiley & Sons, Ltd.
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页码:697 / 705
页数:9
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