Full length article
Pilot 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

https://doi.org/10.1016/j.ejogrb.2017.03.020Get rights and content

Abstract

Introduction

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.

Material and methods

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.

Results

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.

Conclusions

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.

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

References (31)

  • J.J. Morrison et al.

    Neonatal respiratory morbidity and mode of delivery at term: influence of timing of elective caesarean section

    Br J Obstet Gynaecol

    (1995)
  • F.A. Wilmink et al.

    Neonatal outcome following elective cesarean section beyond 37 weeks of gestation: a 7-year retrospective analysis of a national registry

    Am J Obstet Gynecol

    (2010)
  • V. Zanardo et al.

    Neonatal respiratory morbidity risk and mode of delivery at term: influence of timing of elective caesarean delivery

    Acta Paediatr Oslo Nor 1992

    (2004)
  • P. Crowley

    WITHDRAWN: prophylactic corticosteroids for preterm birth

    Cochrane Database Syst Rev

    (2006)
  • P. Stutchfield et al.

    Antenatal betamethasone and incidence of neonatal respiratory distress after elective caesarean section: pragmatic randomised trial

    BMJ

    (2005)
  • Cited by (5)

    • Antenatal corticosteroids after 34 weeks’ gestation: Do we have the evidence?

      2019, Seminars in Fetal and Neonatal Medicine
      Citation 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.

    View full text