The ethics of induction of labor at 39 weeks in low-risk nulliparas in research and clinical practice

被引:7
作者
Azria, Elie [1 ,2 ]
Haaser, Thibaud [3 ,4 ]
Schmitz, Thomas [2 ,5 ]
Froeliger, Alizee [6 ]
Bouchghoul, Hanane [6 ]
Madar, Hugo [6 ]
Pineles, Beth L. [7 ]
Sentilhes, Loic [6 ]
机构
[1] FHU PREMA, Hosp Paris St Joseph, Matern Unit, Paris, France
[2] Univ Paris Cite, Ctr Res Epidemiol & Stat, Womens Hlth IHM,INSERM,INRAE, U1153,Obstet Perinatal & Pediat Epidemiol EPOPe, Paris, France
[3] Univ Hosp Bordeaux, Hlth & Res Eth Ctr, Bordeaux, France
[4] Univ Bordeaux Montaigne, Humanites Univ Bordeaux, Philosophie, UMR 4574 Sci, Pessac, France
[5] Univ Paris Diderot, AP HP, Robert Debre Hosp, Dept Obstet & Gynaecol, Paris, France
[6] Univ Hosp Bordeaux, Dept Obstet & Gynecol, Bordeaux, France
[7] Univ Penn, Perelman Sch Med, Dept Obstet & Gynecol, Philadelphia, PA USA
关键词
autonomy; clinical trial; dual role issue; gender equity; induction of labor; informed consent; justice; medicalization of birth; natural childbirth; nonmedically indicated induction; research ethics; ENROLLING PREGNANT-WOMEN; EXPECTANT MANAGEMENT; FRENCH-ARRIVE; CONSENT; MEMBRANES; DELIVERY; RUPTURE;
D O I
10.1016/j.ajog.2023.07.037
中图分类号
R71 [妇产科学];
学科分类号
100211 ;
摘要
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.
引用
收藏
页码:S775 / S782
页数:8
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