European Journal of Obstetrics & Gynecology and Reproductive Biology
Full length articlePilot randomised controlled trial comparing the risk of neonatal respiratory distress in elective caesarean section at 38 weeks’ gestation following a course of corticosteroids versus caesarean at 39 weeks
Introduction
It is recommended that elective caesarean section should be performed at 39 weeks’ gestation [1], [2]. Approximately 16.5% of women however go into labour during the 38th gestational week, which then requires an emergency caesarean before the scheduled date, giving rise to increased maternal and foetal morbidity [3].
Planning caesarean sections at 38 weeks would therefore enable these complications to be reduced, albeit at the risk of neonatal respiratory distress syndrome (RDS) and transient tachypnoea of the newborn (TTN). Tita et al. have shown that the risk of respiratory complications (RDS or TTN) is likely to decrease from 5.5 to 3.4% (p < 0.0001) between 38 and 39 weeks [4]. Other authors have also replicated this association, whether in respect of the overall neonatal respiratory morbidity [5], [6] or RDS alone [7].
The utility of corticosteroid treatment in reducing the incidence of respiratory distress was demonstrated some time ago for prematurity before 34 weeks and even 37 weeks [8], [9]. Stutchfield has also shown that administering corticosteroids prior to an elective term caesarean section halved (from 5.0% to 2.4%) the number of neonatology admissions for respiratory distress, namely by reducing the rates of RDS and TTN [10]. However his research project studied caesarean sections performed between 37 and 42 weeks, without a specific comparison between 38 and 39 weeks.
This paper’s working hypothesis was that the risk of neonatal respiratory distress for elective caesarean section at 38 weeks following a course of corticosteroids ought to be equivalent to that for elective caesarean section at 39 weeks. The primary objective of this study was to compare the proportion of hospitalisations for neonatal respiratory distress in elective caesareans at 38 weeks following a course of corticosteroids and that of elective caesareans at 39 weeks.
Section snippets
Trial design
This was a prospective multicentre study in which women were randomised into parallel groups (1:1 distribution) with stratification in each centre between elective caesarean section at 38 gestational weeks following a course of corticosteroids and elective caesarean at 39 weeks. The study was validated by the regional ethics committee (CPP Est IV/dossier No. 06/45) and by the Directorate for Clinical Research (dossier HUS 3740). The study was registered with the US National Institutes of Health
Study population
We enrolled 208 women between February 27, 2007 and October 10, 2013: 101 in the corticosteroid group and 107 in the control group. There were no maternal side effects due to the injection of corticosteroids. The study was cut short before reaching the planned number of women owing to difficulties with enrolment. Fig. 1 displays the flow diagram. The number of women assessed for eligibility is unknown. Three women in the corticosteroid group did not receive the assigned intervention. Two women
Main findings
In this study, planning caesarean sections at 38 gestational weeks after a course of corticosteroids did not increase respiratory morbidity compared to elective planning at 39 weeks. Moreover, this strategy enabled a significant reduction in the number of emergency caesareans performed before the scheduled date. Since this was a pilot study however, it lacked the statistical power to indicate significance.
Strengths and weaknesses
This is the first study to assess whether it is possible to plan caesareans earlier by
Funding
This study was funded by the “Appel à Projets Internes” of Strasbourg Teaching Hospital.
Conflicts of interest
The authors declare no financial, personal, political, intellectual, or religious conflict of interests.
Acknowledgements
We would like to thank Dr Boudier, Dr Viville, Dr Kutnahorsky, Dr Chognot, Dr Weber and Dr Keller as well as physicians at Hautepierre, CMCO, Haguenau, Colmar and Mulhouse for participating and enrolling patients in this study.
We would also like to thank Dr Severac for his help regarding the statistical analyses and the Directorate for Clinical Research for their help and especially Hélène Kuissu, Laure Wernert, Hanan Idrissi, Cécile Arnold, Ouafaa Aberkane, Anne-Laure Krieger and Stéphane
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Antenatal corticosteroids after 34 weeks’ gestation: Do we have the evidence?
2019, Seminars in Fetal and Neonatal MedicineCitation Excerpt :A total of 200 pregnancies were included in the per-protocol analysis comparing antenatal betamethasone and planned cesarean section at 38 weeks with planned cesarean section at 39 weeks with no betamethasone. There was no difference in the primary outcome of neonatal unit admission for respiratory distress (2.1% [2/95] after delivery at 38 weeks with betamethasone group and 3.8% [4/105] after delivery at 39 weeks, RR 0.54, 95% CI 0.1, 2.9) but fewer women required emergency cesarean section when birth was planned at 38 weeks after betamethasone (12.7% [12/95] vs 26.7% [28/105], p = 0.01) [69]. These trials demonstrate that corticosteroid use prior to planned cesarean section at term reduces the incidence of short-term respiratory morbidity which may lead to less time in neonatal intensive care, and so potentially improved maternal bonding and higher breastfeeding rates.
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2018, Cochrane Database of Systematic Reviews