Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery

Summary

To demonstrate that the intramuscular administration of 17 alpha hydroxyprogesterones caproate allows to reduce the risk of preterm delivery, in 3 high risk populations defined by the association of an ultrasonographic cervical length egal and inferiority 26 mm between 20 and 32 weeks of gestation and: * either a first episode of preterm labor stopped by acute tocolysis; * either a history of late miscarriage or premature delivery or uterine malformation or DES * either a twin pregnancy. Therefore, a randomised, multicentre trial has been designed with initial stratification according to these three risk groups, opened with two parallel arms.

Timeline

Start

2006-06

Primary completion

2010-05

Completion

2010-05

Outcome

Missed primary endpoint

paper an interim analysis demonstrated the lack of efficacy of 17OHP-C in prolonging pregnancy. PMID 25448515 ↗

paper 17OHP-C did not prolong pregnancy in women with singleton gestations, a sonographic short cervix, and other risk factors of preterm delivery PMID 25448515 ↗

Publications

• Background Rozenberg P, Rudant J, Chevret S, Boulogne AI, Ville Y. Repeat measurement of cervical length after successful tocolysis. Obstet Gynecol. 2004 Nov;104(5 Pt 1):995-9. doi: 10.1097/01.AOG.0000143254.27255.e9.
• Winer N, Bretelle F, Senat MV, Bohec C, Deruelle P, Perrotin F, Connan L, Vayssiere C, Langer B, Capelle M, Azimi S, Porcher R, Rozenberg P; Groupe de Recherche en Obstetrique et Gynecologie. 17 alpha-hydroxyprogesterone caproate does not prolong pregnancy or reduce the rate of preterm birth in women at high risk for preterm delivery and a short cervix: a randomized controlled trial. Am J Obstet Gynecol. 2015 Apr;212(4):485.e1-485.e10. doi: 10.1016/j.ajog.2014.10.1097. Epub 2014 Oct 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	17 alpha-hydroxyprogesterones caproate	Unknown	500 mg	Intramuscular

Indications

No indication recorded.