Vaginal Progesterone to Prevent Spontaneous Preterm Birth in Women With a Sonographic Short Cervix: The Story of the PREGNANT Trial

被引:2
|
作者
Romero, Roberto [1 ,2 ,3 ]
Meyyazhagan, Arun [1 ,4 ,5 ]
Hassan, Sonia S. [4 ,6 ,7 ]
Creasy, George W. [8 ]
Conde-Agudelo, Agustin [9 ]
机构
[1] Eunice Kennedy Shriver Natl Inst Child Hlth & Hum, Pregnancy Res Branch, Div Obstet & Maternal Fetal Med, Div Intramural Res,US Dept Hlth & Human Serv,NIH, Bethesda, MD 20892 USA
[2] Univ Michigan, Dept Obstet & Gynecol, Ann Arbor, MI USA
[3] Michigan State Univ, Dept Epidemiol & Biostat, E Lansing, MI USA
[4] Wayne State Univ, Sch Med, Dept Obstet & Gynecol, Detroit, MI USA
[5] Univ Perugia, Ctr Perinatal & Reprod Med, Perugia, Italy
[6] Wayne State Univ, Dept Obstet & Gynecol, Off Womens Hlth, Integrat Biosci Ctr, Detroit, MI 48201 USA
[7] Wayne State Univ, Sch Med, Dept Physiol, Detroit, MI 48201 USA
[8] Ctr Biomed Res, Populat Council, New York, NY USA
[9] Univ Oxford, Oxford Maternal & Perinatal Hlth Inst, Green Templeton Coll, Oxford, England
来源
CLINICAL OBSTETRICS AND GYNECOLOGY | 2024年 / 67卷 / 02期
基金
美国国家卫生研究院;
关键词
neonatal morbidity; number needed to treat; progestogen; regulatory review; respiratory distress syndrome (RDS); short cervix; RESPIRATORY-DISTRESS-SYNDROME; FACTOR-KAPPA-B; ACTIVATING PEPTIDE-1 INTERLEUKIN-8; DOUBLE-BLIND; AMNIOTIC-FLUID; COST-EFFECTIVENESS; PREMATURE RUPTURE; PROGESTATIONAL AGENTS; TRANSCRIPTION FACTOR; HORMONAL-REGULATION;
D O I
10.1097/GRF.0000000000000867
中图分类号
R71 [妇产科学];
学科分类号
100211 ;
摘要
The PREGNANT trial was a randomized, placebo-controlled, multicenter trial designed to determine the efficacy and safety of vaginal progesterone (VP) to reduce the risk of birth <33 weeks and of neonatal complications in women with a sonographic short cervix (10 to 20 mm) in the mid-trimester (19 to 23 6/7 wk). Patients allocated to receive VP had a 45% lower rate of preterm birth (8.9% vs 16.1%; relative risk = 0.55; 95% CI: 0.33-0.92). Neonates born to mothers allocated to VP had a 60% reduction in the rate of respiratory distress syndrome. This article reviews the background, design, execution, interpretation, and impact of the PREGNANT Trial.
引用
收藏
页码:433 / 457
页数:25
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