Prevention of preterm delivery after successful tocolysis in preterm labor by 17 alpha-hydroxyprogesterone caproate: A randomized controlled trial

• Published in: American journal of obstetrics and gynecology Vol. 206; no. 3; pp. 206.e1 - 206.e9
• Main Authors: Rozenberg, Patrick, MD, Chauveaud, Aurelia, MD, Deruelle, Philippe, MD, PhD, Capelle, Marianne, MD, Winer, Norbert, MD, PhD, Desbrière, Raoul, MD, Perrotin, Frank, MD, PhD, Bohec, Caroline, MD, Connan, Laure, MD, Vayssière, Christophe, MD, PhD, Langer, Bruno, MD, PhD, Mantel, Aymeric, MD, Azimi, Shohreh, Porcher, Raphael, MD, PhD, Azria, Elie, MD, PhD
• Format: Journal Article Conference Proceeding
• Language: English
• Published: New York, NY Mosby, Inc 01.03.2012; Elsevier
• Subjects: 17 alpha-hydroxyprogesterone caproate; Adult; Biological and medical sciences; cervical length; Diseases of mother, fetus and pregnancy; Female; Gynecology. Andrology. Obstetrics; Humans; Hydroxyprogesterones - therapeutic use; Medical sciences; Obstetric Labor, Premature - prevention & control; Obstetrics and Gynecology; Pregnancy; Pregnancy Outcome; Pregnancy. Fetus. Placenta; Premature Birth - prevention & control; preterm delivery; preterm labor; Tocolysis; Tocolytic Agents - therapeutic use; Treatment Outcome; ultrasonography; preterm labor; ultrasonography; preterm delivery; 17 alpha-hydroxyprogesterone caproate; cervical length; Prevention; Randomization; Pregnancy disorders; Hydroxyprogesterone caproate; Gynecology; Premature delivery; Clinical trial; Obstetrics; Tocolysis
• ISSN: 0002-9378; 1097-6868
• DOI: 10.1016/j.ajog.2011.12.026

Objective The objective of the study was to evaluate the use of 17 alpha-hydroxyprogesterone caproate (17P) to reduce preterm delivery. Study Design This open-label, multicenter, randomized controlled trial included women with singleton pregnancies admitted at 24-31 weeks' gestation and cervical length less than 25 mm for preterm labor successfully arrested by tocolytic treatment. Randomization assigned them to receive (or not) 500 mg of intramuscular 17P after tocolysis ended, repeated semiweekly until 36 weeks or preterm delivery. The primary outcome was the time from randomization to delivery. Results Outcome data were available for 184 of 188 women randomized. The 17P and control groups (similar for most baseline characteristics) did not differ significantly for median [interquartile range] time to delivery (64 [42–79] and 67 [46–83] days, respectively) or rates of delivery before 37, 34, or 32 weeks of gestation or adverse perinatal outcomes. Conclusion Semiweekly injections of 17P did not prolong pregnancy significantly in women with tocolysis-arrested preterm labor.