title: Off-label use of misoprostol for labor induction in Germany: a national survey.
abstract: OBJECTIVE
  Misoprostol is safe and effective for labor induction in viable pregnancies. Little is known about the prevalence of off-label use of misoprostol, and the reasons for using or not using misoprostol for labor induction. As such, a national survey was conducted in Germany to assess reliable data about the use of misoprostol in clinical practice.
  
  
  METHODS
  A prospective study was performed in 2013 using a standardized survey questionnaire. All registered departments of obstetrics and gynecology in Germany were targeted.
  
  
  RESULTS
  Out of 783 questionnaires, 542 (69%) were returned. Three hundred and fifty-five (66%) respondents reported that they use misoprostol for labor induction in viable term pregnancies, and 183 (34%) respondents reported that they never use misoprostol for this indication. The most common reasons given for using misoprostol in labor induction were: effectiveness (40%), good patient acceptance (35%), established/well proven in clinical practice (35%) and cost-effectiveness (32%). The most common reasons given for not using misoprostol were lack of licence (off-label use, 69%) and uncertainty of the legal situation (27%).
  
  
  CONCLUSIONS
  Although misoprostol is not licensed in Germany for obstetric indications, the vast majority of respondents (66%) reported that they use misoprostol for labor induction. The main reasons for not using misoprostol for labor induction in Germany are legal concerns rather than lack of scientific evidence. Cost-effective medications with evidence-based effectiveness and safety should be supported by a clear statement from national medical societies.
authors.affiliation: Department of Obstetrics and Gynaecology, RWTH Aachen University Hospital, Aachen, Germany. Electronic address: fvoigt@ukaachen.de.
authors.forename: F
authors.initials: F
authors.lastname: Voigt
authors.affiliation: Department of Obstetrics and Gynaecology, RWTH Aachen University Hospital, Aachen, Germany.
authors.forename: T W
authors.initials: TW
authors.lastname: Goecke
authors.affiliation: Department of Obstetrics and Gynaecology, RWTH Aachen University Hospital, Aachen, Germany.
authors.forename: L
authors.initials: L
authors.lastname: Najjari
authors.affiliation: Department of Obstetrics and Gynaecology, RWTH Aachen University Hospital, Aachen, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Pecks
authors.affiliation: Department of Obstetrics and Gynaecology, RWTH Aachen University Hospital, Aachen, Germany.
authors.forename: N
authors.initials: N
authors.lastname: Maass
authors.affiliation: Faculty of Medicine, Gynaecology and Obstetrics, RWTH Aachen University Hospital, Aachen, Germany.
authors.forename: W
authors.initials: W
authors.lastname: Rath
mesh_terms: D005260:Female; D005858:Germany; D019538:Health Care Surveys; D006801:Humans; D007751:Labor, Induced; D016595:Misoprostol / Q000008:administration & dosage*; D056687:Off-Label Use / Q000331:legislation & jurisprudence / Q000706:statistics & numerical data; D010120:Oxytocics; D011247:Pregnancy; D011446:Prospective Studies; D011795:Surveys and Questionnaires
chemical_list: D010120:Oxytocics; D016595:Misoprostol
keywords: Cytotec; Labor induction; Licence; Misoprostol; Off-label