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The ethics of induction of labor at 39 weeks in low-risk nulliparas in research and clinical practice.
Azria, Elie; Haaser, Thibaud; Schmitz, Thomas; Froeliger, Alizée; Bouchghoul, Hanane; Madar, Hugo; Pineles, Beth L; Sentilhes, Loïc.
Afiliação
  • Azria E; Maternity Unit, Hospital Paris Saint-Joseph, FHU PREMA, Paris, France; Obstetrical Perinatal and Pediatric Epidemiology Research Team, CRESS, EPOPé, INSERM, INRA, Université de Paris Cité, Paris, France.
  • Haaser T; Health and Research Ethics Centre, University Hospital of Bordeaux, Bordeaux, France; Sciences, Philosophie, Humanités, Université de Bordeaux-Université Bordeaux-Montaigne, Domaine Universitaire, Pessac, France.
  • Schmitz T; Obstetrical Perinatal and Pediatric Epidemiology Research Team, CRESS, EPOPé, INSERM, INRA, Université de Paris Cité, Paris, France; Department of Obstetrics and Gynaecology, Robert Debré Hospital, AP-HP, Paris Diderot University, Paris, France.
  • Froeliger A; Department of Obstetrics and Gynecology, University Hospital of Bordeaux, Bordeaux, France.
  • Bouchghoul H; Department of Obstetrics and Gynecology, University Hospital of Bordeaux, Bordeaux, France.
  • Madar H; Department of Obstetrics and Gynecology, University Hospital of Bordeaux, Bordeaux, France.
  • Pineles BL; Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
  • Sentilhes L; Department of Obstetrics and Gynecology, University Hospital of Bordeaux, Bordeaux, France. Electronic address: loicsentilhes@hotmail.com.
Am J Obstet Gynecol ; 230(3S): S775-S782, 2024 Mar.
Article em En | MEDLINE | ID: mdl-37633577
The "A Randomized Trial of Induction Versus Expectant Management" trial (ARRIVE trial) published in 2018 suggested that induction of labor can be considered a "reasonable option" for low-risk nulliparous women at ≥39 weeks of gestation. The study results led some professional societies to endorse the option for elective induction of labor at 39 weeks of gestation in low-risk nulliparas, and this has begun to change obstetrical practice. The ARRIVE trial provided valuable information supporting the benefits of induction of labor; however, the trial is insufficient to serve as the primary justification for widespread elective induction of labor at 39 weeks of gestation in low-risk nulliparas because of concerns about external validity. Thus, the French ARRIVE trial was designed to test the hypothesis in a different setting that elective induction of labor at 39 weeks of gestation in low-risk nulliparas leads to a lower cesarean delivery rate than expectant management. This ongoing trial has been criticized as "pseudoscientific" and telling "women where, when, and how to give birth." We reject these allegations and extensively examine the ethical framework that should govern clinical and research interventions, including elective induction of labor at 39 weeks of gestation in low-risk nulliparas. This study aimed to discuss the ethical issues that emerge from randomized trials of elective induction of labor at 39 weeks of gestation in low-risk nulliparas and the ethics of the clinical practice itself. The analysis of existing evidence shows the importance of further research on induction of labor at 39 weeks of gestation in low-risk women. Certain aspects of research ethics in this area, particularly the consent of pregnant women in a context where autonomy remains fragile, call for vigilance. In addition, we emphasize that childbirth is not only a medical object but also a social phenomenon that cannot be regarded only from the perspective of a health risk to be managed by clinical research. Further research on this issue is needed to allow pregnant women to make informed decisions, and the results should be integrated with social issues. The perspective of women is required in constructing, evaluating, and implementing medical interventions in childbirth, such as induction of labor at 39 weeks of gestation.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Trabalho de Parto / Trabalho de Parto Induzido Tipo de estudo: Clinical_trials / Etiology_studies / Prognostic_studies / Risk_factors_studies Limite: Female / Humans / Pregnancy Idioma: En Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Trabalho de Parto / Trabalho de Parto Induzido Tipo de estudo: Clinical_trials / Etiology_studies / Prognostic_studies / Risk_factors_studies Limite: Female / Humans / Pregnancy Idioma: En Ano de publicação: 2024 Tipo de documento: Article