title: 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.
abstract: OBJECTIVE
  The objective of the study was to evaluate the efficacy of 17 alpha-hydroxyprogesterone caproate (17OHP-C) in prolonging gestation in patients with a short cervix and other risk factors for preterm delivery, such as previous preterm birth, cervical surgery, uterine anomalies, or prenatal diethylstilbestrol (DES) exposure.
  
  
  METHODS
  This open-label, multicenter, randomized controlled trial included asymptomatic singleton pregnancies from 20(+0) through 31(+6) weeks of gestation with a cervical length less than 25 mm and a history of preterm delivery or cervical surgery or uterine malformation or prenatal DES exposure. Randomization assigned them to receive (or not) 500 mg of intramuscular 17OHP-C weekly until 36 weeks. The primary outcome was time from randomization to delivery.
  
  
  RESULTS
  After enrolling 105 patients, an interim analysis demonstrated the lack of efficacy of 17OHP-C in prolonging pregnancy. The study was discontinued because of futility. The groups were similar for maternal age, body mass index, parity, gestational age at inclusion, history of uterine anomalies, DES syndrome, previous preterm delivery or midtrimester abortion, and cervical length at randomization. The enrollment-to-delivery interval did not differ between patients allocated to 17OHP-C (n = 51) and those allocated to the control group (n = 54) (median [interquartile range] time to delivery: 77 [54-103] and 74 [52-99] days, respectively). The rate of preterm delivery less than 37 (45% vs 44%, P > .99), less than 34 (24% vs 30%, P = .51), or less than 32 (14% vs 20%, P = .44) weeks was similar in patients allocated to 17OHP-C and those in the control group.
  
  
  CONCLUSIONS
  17OHP-C did not prolong pregnancy in women with singleton gestations, a sonographic short cervix, and other risk factors of preterm delivery (prior history, uterine malformations, cervical surgery, or prenatal DES exposure).
authors.affiliation: Department of Obstetrics and Gynecology, Hôpital Mère-Enfant, Nantes, France.
authors.forename: Norbert
authors.initials: N
authors.lastname: Winer
authors.affiliation: Department of Obstetrics and Gynecology, Hôpital Nord, Marseille, France.
authors.forename: Florence
authors.initials: F
authors.lastname: Bretelle
authors.affiliation: Department of Obstetrics and Gynecology, Assistance Publique-Hôpitaux de Paris, Hôpital Bicêtre, Hôpital Antoine Béclère, Université Paris Sud, Faculté de Médecine Paris XI, Paris, France.
authors.forename: Marie-Victoire
authors.initials: MV
authors.lastname: Senat
authors.affiliation: Department of Obstetrics and Gynecology, Hôpital Morvan, Brest, France.
authors.forename: Caroline
authors.initials: C
authors.lastname: Bohec
authors.affiliation: Department of Obstetrics and Gynecology, Hôpital Jeanne de Flandre, Lille, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Deruelle
authors.affiliation: Department of Obstetrics and Gynecology, Hôpital Bretonneau, Tours, France.
authors.forename: Frank
authors.initials: F
authors.lastname: Perrotin
authors.affiliation: Department of Obstetrics and Gynecology, Hôpital Paul de Viguier, Toulouse, France.
authors.forename: Laure
authors.initials: L
authors.lastname: Connan
authors.affiliation: Department of Obstetrics and Gynecology, Centre Médico-Chirurgical Obstetrical, Schiltigheim, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Vayssière
authors.affiliation: Department of Obstetrics and Gynecology, Hôpital Hautepierre, Strasbourg, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Langer
authors.affiliation: Department of Obstetrics and Gynecology, Hôpital de La Conception, Marseille, France.
authors.forename: Marianne
authors.initials: M
authors.lastname: Capelle
authors.affiliation: Department of Clinical Research, Ile-de-France, Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Paris, France.
authors.forename: Shohreh
authors.initials: S
authors.lastname: Azimi
authors.affiliation: Department of Biostatistics, Hôpital Saint-Louis, Paris Diderot University, and Institut National de la Santé et de la Recherche Médicale, Paris, France.
authors.forename: Raphael
authors.initials: R
authors.lastname: Porcher
authors.affiliation: Department of Obstetrics and Gynecology, Hôpital Poissy-Saint Germain, Versailles-Saint Quentin University, Versailles, France. Electronic address: prozenberg@chi-poissy-st-germain.fr.
authors.forename: Patrick
authors.initials: P
authors.lastname: Rozenberg
mesh_terms: D000077713:17 alpha-Hydroxyprogesterone Caproate; D000328:Adult; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006908:Hydroxyprogesterones / Q000627:therapeutic use*; D007273:Injections, Intramuscular; D057194:Intention to Treat Analysis; D011247:Pregnancy; D047928:Premature Birth / Q000209:etiology / Q000517:prevention & control*; D011295:Prenatal Care / Q000379:methods*; D011372:Progestins / Q000627:therapeutic use*; D016016:Proportional Hazards Models; D012307:Risk Factors; D016896:Treatment Outcome; D014564:Urogenital Abnormalities / Q000150:complications; D002581:Uterine Cervical Incompetence; D014599:Uterus / Q000002:abnormalities
chemical_list: D006908:Hydroxyprogesterones; D011372:Progestins; D000077713:17 alpha-Hydroxyprogesterone Caproate
keywords: 17 alpha-hydroxyprogesterone caproate; cervical length; prematurity; preterm birth; preterm labor; progesterone