Sananès Nicolas, Koch Antoine, Escande Benoît, Aissi Germain, Fritz Gabrielle, Roth Emmanuel, Weil Michèle, Bakri Ahmad, Bolender Chantal, Meyer Nicolas, Vayssiere Christophe, Gaudineau Adrien, Nisand Israël, Favre Romain, Kuhn Pierre, Langer Bruno
Department of Obstetrics and Gynecology, Strasbourg Teaching Hospital, France; UMR-S 1121 Inserm, "Biomatériaux et Bioingénierie", Strasbourg, France.
Department of Obstetrics and Gynecology, Strasbourg Teaching Hospital, France.
Eur J Obstet Gynecol Reprod Biol. 2017 May;212:54-59. doi: 10.1016/j.ejogrb.2017.03.020. Epub 2017 Mar 10.
The objective of this study was to compare neonatal respiratory morbidity and rate of emergency caesarean section between elective caesarean sections at 38 gestational weeks following a course of corticosteroids and planned caesarean sections at 39 gestational weeks.
This was a multicentre randomised controlled trial. The study was conducted between 2007 and 2013 in level 2 and 3 maternity units in France. A total of 208 women with an indication for elective caesarean section were enrolled and 200 analysed in per-protocol analysis. Women were randomised to either elective caesarean section at 38 gestational weeks after a course of corticosteroids (trial group) or elective caesarean section at 39 weeks (control group). The primary outcome was the rate of admission to the neonatal intensive care unit for respiratory distress.
Two (2.1%) newborn in the tested group were admitted because of respiratory distress versus four (3.8%) in the control group. The relative risk was 0.54 in favour of the corticosteroid group (95% CI: 0.10; 2.86). There were fewer emergency caesareans in the trial group than in the control group: 12 (12.69%) versus 28 (26.67%), p=0.01.
Our study suggests that planning caesarean sections at 38 gestational weeks after a course of corticosteroids would enable a significant reduction in the number of emergency caesareans without increasing the risk of neonatal respiratory distress. Limitations of this study include difficulties in patient recruitment and the small number of subjects.
本研究的目的是比较在接受一个疗程皮质类固醇治疗后38孕周选择性剖宫产与39孕周计划剖宫产之间的新生儿呼吸疾病发病率及急诊剖宫产率。
这是一项多中心随机对照试验。该研究于2007年至2013年在法国的二级和三级产科单位进行。共有208名有选择性剖宫产指征的妇女入组，按符合方案分析纳入200名进行分析。妇女被随机分为接受一个疗程皮质类固醇治疗后38孕周选择性剖宫产（试验组）或39孕周选择性剖宫产（对照组）。主要结局是因呼吸窘迫入住新生儿重症监护病房的比例。
试验组有2名（2.1%）新生儿因呼吸窘迫入院，而对照组有4名（3.8%）。皮质类固醇组的相对风险为0.54（95%可信区间：0.10；2.86）。试验组急诊剖宫产少于对照组：12例（12.69%）对28例（26.67%），p=0.01。
我们的研究表明，在接受一个疗程皮质类固醇治疗后38孕周计划剖宫产可显著减少急诊剖宫产数量，且不增加新生儿呼吸窘迫风险。本研究的局限性包括患者招募困难和样本量小。
