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.
BACKGROUND
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.


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.
Department of Obstetrics and Gynecology, Strasbourg Teaching Hospital, France; UMR-S 1121 Inserm, "Biomatériaux et Bioingénierie", Strasbourg, France. Electronic address: nicolas.sananes@chru-strasbourg.fr.
Nicolas
N
Sananès
Department of Obstetrics and Gynecology, Strasbourg Teaching Hospital, France.
Antoine
A
Koch
Department of Pediatrics, Strasbourg Teaching Hospital, France.
Benoît
B
Escande
Department of Obstetrics and Gynecology, Strasbourg Teaching Hospital, France.
Germain
G
Aissi
Department of Obstetrics and Gynecology, Strasbourg Teaching Hospital, France.
Gabrielle
G
Fritz
Department of Obstetrics and Gynecology, Strasbourg Teaching Hospital, France.
Emmanuel
E
Roth
Department of Pediatrics, Strasbourg Teaching Hospital, France.
Michèle
M
Weil
Department of Obstetrics and Gynecology, Hospital of Haguenau, France.
Ahmad
A
Bakri
Department of Pediatrics, Hospital of Haguenau, France.
Chantal
C
Bolender
Department of Public Health, Strasbourg Teaching Hospital, France.
Nicolas
N
Meyer
Department of Obstetrics and Gynecology, Toulouse Teaching Hospital, France.
Christophe
C
Vayssiere
Department of Obstetrics and Gynecology, Strasbourg Teaching Hospital, France.
Adrien
A
Gaudineau
Department of Obstetrics and Gynecology, Strasbourg Teaching Hospital, France.
Israël
I
Nisand
Department of Obstetrics and Gynecology, Strasbourg Teaching Hospital, France.
Romain
R
Favre
Department of Pediatrics, Strasbourg Teaching Hospital, France.
Pierre
P
Kuhn
Department of Obstetrics and Gynecology, Strasbourg Teaching Hospital, France.
Bruno
B
Langer
D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D000328:Adult; D016022:Case-Control Studies; D002585:Cesarean Section / Q000706:statistics & numerical data*; D005260:Female; D005865:Gestational Age; D006801:Humans; D007231:Infant, Newborn; D007363:Intensive Care Units, Neonatal / Q000706:statistics & numerical data; D057194:Intention to Treat Analysis; D008297:Male; D010865:Pilot Projects; D011247:Pregnancy; D012127:Respiratory Distress Syndrome, Newborn / Q000517:prevention & control*; D012307:Risk Factors
D000305:Adrenal Cortex Hormones
Antenatal corticosteroids; Elective caesarean; Emergency caesarean; Neonatal respiratory distress