Lower Uterine Segment Trial: A pragmatic open multicenter randomized trial

• Published in: Gynécologie Obstétrique Fertilité & Sénologie
• Main Authors: Rozenberg, Patrick, Deruelle, Philippe, Sénat, Marie Victoire, Desbrière, Raoul, Winer, Norbert, Simon, E. G., Ville, yves G., Kayem, Gilles, Boutron, Isabelle
• Other Authors: Risques cliniques et sécurité en santé des femmes et en santé périnatale (RISCQ), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Maternité Jeanne de Flandre, Centre Hospitalier Régional Universitaire Lille (CHRU Lille), Hôpital Bicêtre, Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Bicêtre, Hôpital Saint-Joseph Marseille, Hôpital Mère Enfant CHU Nantes, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), CHU Necker - Enfants Malades AP-HP, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de Gynécologie-Obstétrique CHU Trousseau, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Trousseau APHP, Hôpital Hôtel-Dieu Paris
• Format: Article in Journal/Newspaper
• Language: English
• Published: HAL CCSD 2018
• Subjects: Uterine rupture; Ultrasound; Uterine dehiscence; Ultrasonography; Cesarean delivery; Trial of labor; [SDV]Life Sciences [q-bio]; SCAR
• Online Access: https://hal.archives-ouvertes.fr/hal-02560874; https://doi.org/10.1016/j.gofs.2018.03.005

International audience Background: The data from literature show that trial of labor and elective repeat cesarean delivery after a prior cesarean delivery both present significant risks and benefits, and these risks and benefits differ for the woman and her fetus. The benefits to the woman can be at the expense of her fetus and vice-versa. This uncertainty is compounded by the scarcity of high-level evidence that preclude accurate quantification of the risks and benefits that could help provide a fair counseling about a trial of labor and elective repeat cesarean delivery. An interesting way of research is to evaluate the potential benefits of a decision rule associated to the ultrasound measurement of the lower uterine segment (LUS). Indeed, ultrasonography may be helpful in determining a specific risk for a given patient by measuring the thickness of the LUS, i,e, the thickness of the cesarean delivery scar area. Although only small and often methodologically biased data have been published, they look promising as their results are concordant: ultrasonographic measurements of the LUS thickness is highly correlated with the intraoperative findings at cesarean delivery. Furthermore, the thinner the LUS becomes on ultrasound, the higher the likelihood of a defect in the LUS. Finally, ultrasound assessment of LUS has an excellent negative predictive value for the risk of uterine defect. Therefore, this exam associated with a rule of decision could help to reduce the rate of elective repeat cesarean delivery and especially to reduce the fetal and maternal mortality and morbidity related to trial of labor after a prior cesarean delivery. Methods/design: This is a pragmatic open multicenter randomized trial with two parallel arms. Randomization will be centralized and computerized. Since blindness is impossible, an adjudication committee will evaluate the components of the primary composite outcome in order to avoid evaluation bias. An interim analysis will be planned mid-strength of the trial. Ultrasound will be ...