Prevention of preterm delivery by 17 alpha-hydroxyprogesterone caproate in asymptomatic twin pregnancies with a short cervix: a randomized controlled trial

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• 作者：Marie-Victoire Senat ; MD ; PhD^a ; ^{marie-victoire.senat@bct.aphp.fr} ; Raphael Porcher ; MD ; PhD^b ; Norbert Winer ; MD ; PhD^c ; Christophe Vayssiè ; re ; MD ; PhD^d ; Philippe Deruelle ; MD ; PhD^e ; Marianne Capelle ; MD^f ; Florence Bretelle ; MD ; PhD^g ; Frank Perrotin ; MD ; PhD^h ; Yves Laurent ; MDⁱ ; Laure Connan ; MD^j ; Bruno Langer ; MD ; PhD^k ; Aymeric Mantel ; MD^l ; Shohreh Azimiⁿ ; Patrick Rozenberg ; MD^m ; Groupe de Recherche en Obsté ; trique et Gyné ; cologie
• 关键词：17 alpha-hydroxyprogesterone caproate ; cervical length ; preterm delivery ; twins ; ultrasonography
• 刊名：American Journal of Obstetrics and Gynecology
• 出版年：2013
• 出版时间：March, 2013
• 年：2013
• 卷：208
• 期：3
• 页码：194.e1-194.e8
• 全文大小：564 K

文摘

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Objective

The objective of the study was to evaluate the use of 17 alpha-hydroxyprogesterone caproate (17P) to reduce preterm delivery in women with a twin pregnancy and short cervix.

Study Design

This open-label, multicenter, randomized controlled trial included women with a twin pregnancy between 24⁺⁰ and 31⁺⁶ weeks of gestation who were asymptomatic and had a cervical length of 25 mm or less measured by routine transvaginal ultrasound. Women were randomized to receive (or not) 500 mg of intramuscular 17P, repeated twice weekly until 36 weeks or preterm delivery. The primary outcome was time from randomization to delivery. Analysis was performed according to the intent-to-treat principle.

Results

The 17P and control groups did not differ significantly for median [interquartile range] time to delivery: 45 (26-62) and 51 (36-66) days, respectively. However, treatment with 17P was associated with a significant increase in the rate of preterm delivery before 32 weeks.

Conclusion

Twice-weekly injections of 17P did not prolong pregnancy significantly in asymptomatic women with a twin pregnancy and short cervix.