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Evaluation of the usefulness of ultrasound measurement of the lower uterine segment before delivery of women with a prior cesarean delivery: a randomized trial

Authors :
Emmanuel Simon
Isabelle Boutron
Raphaël Porcher
Philippe Deruelle
Elodie Perrodeau
Raoul Desbriere
Yves Ville
Patrick Rozenberg
Norbert Winer
Marie-Victoire Senat
Gilles Kayem
Groupe de Recherche en Obstétrique et Gynécologie
HAL UVSQ, Équipe
Risques cliniques et sécurité en santé des femmes et en santé périnatale (RISCQ)
Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)
Service de gynécologie et obstétrique [CHI Poissy-Saint Germain]
CHI Poissy-Saint-Germain
AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre)
Service de Gynécologie - Obstétrique [Lille]
Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)
Centre hospitalier universitaire de Nantes (CHU Nantes)
Physiopathologie des Adaptations Nutritionnelles (PhAN)
Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Nantes Université - UFR de Médecine et des Techniques Médicales (Nantes Univ - UFR MEDECINE)
Nantes Université - pôle Santé
Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Nantes Université - pôle Santé
Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)
Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)
CHU Necker - Enfants Malades [AP-HP]
Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)
CHU Trousseau [APHP]
Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)
Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153))
Conservatoire National des Arts et Métiers [CNAM] (CNAM)
HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)
Centre d'épidémiologie Clinique [Hôtel-Dieu]
Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital Hôtel Dieu
Hôpital Saint-Joseph [Marseille]
Ministère des Affaires Sociales et de la Santé: PHRC R 12139
This study was funded by a research grant from the French Ministry of Health ( PHRC R 12139 ) and sponsored by the Département de la Recherche Clinique et du Développement de l’Assistance Publique-Hôpitaux de Paris. The sponsor did not participate in the study design, data analysis, data interpretation, or writing of the report. All authors confirm that they had full access to the data in the study and accept responsibility for submitting the article for publication.
This study was funded by a research grant from the French Ministry of Health (PHRC R 12139) and sponsored by the D?partement de la Recherche Clinique et du D?veloppement de l'Assistance Publique-H?pitaux de Paris. The sponsor did not participate in the study design, data analysis, data interpretation, or writing of the report. All authors confirm that they had full access to the data in the study and accept responsibility for submitting the article for publication.
Source :
American Journal of Obstetrics and Gynecology, American Journal of Obstetrics and Gynecology, 2022, 226 (2), pp.253.e1-253.e9. ⟨10.1016/j.ajog.2021.08.005⟩
Publication Year :
2022
Publisher :
HAL CCSD, 2022.

Abstract

International audience; Background: The main reason to avoid trial of labor after cesarean delivery is the possibility of uterine rupture. Identifying women at risk is thus an important aim, for it would enable women at low risk to proceed with a secure planned vaginal birth. bjective: To evaluate the impact of proposing mode of delivery based on the ultrasound measurement of the lower uterine segment thickness on a composite outcome of maternal-fetal mortality and morbidity, compared with usual management, among pregnant women with a previous cesarean delivery.Study Design: This multicenter, randomized, controlled, parallel-group, unmasked trial was conducted at 8 referral university hospitals with a neonatal intensive care unit and enrolled 2948 women at 36 weeks 0 days to 38 weeks 6 days of gestation with 1 previous low transverse cesarean delivery and no contraindication to trial of labor. Women in the study group had their lower uterine segment thickness measured by ultrasound. Those with measurements >3.5 mm, were encouraged to choose a planned vaginal delivery, and those with measurements ≤3.5 mm, were encouraged to choose a planned repeat cesarean delivery. This measurement was not taken in the control group; their mode of delivery was decided according to standard management. The primary outcome was a composite criterion comprising maternal mortality, uterine rupture, uterine dehiscence, hysterectomy, thromboembolic disease, transfusion, endometritis, perinatal death, or neonatal encephalopathy. Prespecified secondary outcomes were repeat cesarean deliveries, elective or after trial of labor.Results: The study group included 1472 women, and the control group included 1476 women. These groups were similar at baseline. The primary outcome occurred in 3.4% of the study group and 4.3% of the control group (relative risk, 0.78; 95% confidence interval, 0.54–1.13: risk difference, −1.0%; 95% confidence interval, −2.4 to 0.5). The uterine rupture rate in the study group was 0.4% and in the control group 0.9% (relative risk, 0.43; 95% confidence interval, 0.15–1.19). The planned cesarean delivery rate was 16.4% in the study group and 13.7% in the control group (relative risk, 1.21; 95% confidence interval, 1.00–1.47), whereas the rates of cesarean delivery during labor were 25.1% and 25.0% (relative risk, 1.01; 95% confidence interval, 0.89–1.14) in the study and control groups, respectively.Conclusion: Ultrasound measurements of lower uterine segment thickness did not result in a statistically significant lower frequency of maternal and perinatal adverse outcomes than standard management. However, because this study was underpowered, further research should be encouraged.

Details

Language :
English
ISSN :
00029378 and 10976868
Database :
OpenAIRE
Journal :
American Journal of Obstetrics and Gynecology, American Journal of Obstetrics and Gynecology, 2022, 226 (2), pp.253.e1-253.e9. ⟨10.1016/j.ajog.2021.08.005⟩
Accession number :
edsair.doi.dedup.....e02ab0857ccfa45524fa6df2a633f413