TITLE PAGE
Title: Effect of antenatal corticosteroids in late preterm delivery on
neonatal morbidity: A Randomised Controlled Trial
Authors
- Anisah Yahya. Department of Obstetrics and Gynecology, College of
Medical Sciences, Ahmadu Bello University/Ahmadu Bello University
Teaching Hospital, Zaria, Nigeria.
- Hajaratu Umar Sulayman. Department of Obstetrics and Gynecology,
College of Medical Sciences, Ahmadu Bello University/Ahmadu Bello
University Teaching Hospital, Zaria, Nigeria.
- Isa Abdulkadir. Department of Paediatrics, College of Medical
Sciences, Ahmadu Bello University/Ahmadu Bello University Teaching
Hospital, Zaria, Nigeria.
- Bola Biliaminu Lawal. Department of Community Medicine, College of
Medical Sciences, Ahmadu Bello University Zaria, Nigeria.
Corresponding author
Anisah Yahya. Department of Obstetrics and Gynecology, College of
Medical Sciences, Ahmadu Bello University/Ahmadu Bello University
Teaching Hospital, Zaria, Nigeria
+2348035925175,
anisahy@yahoo.com,
anisahungogo@gmail.com
ayahya@abu.edu.ng
Running title: Antenatal corticosteroids in late preterm delivery
ABSTRACT
Objective: The use of antenatal corticosteroids beyond 34 weeks of
gestation remains a debate. This study sought to determine the effect of
use of antenatal corticosteroids in late preterm delivery on neonatal
morbidity.
Design: It was a randomized double-blind placebo and active controlled
multi arm trial. There were two study groups and one control group.
Setting: It was conducted at the department of Obstetrics and
Gynaecology and the Department of Paediatrics of Ahmadu Bello University
Teaching Hospital Zaria.
Population: Pregnant women at 34 weeks 0 days to 36 weeks 6 days of
gestation scheduled for elective/emergency delivery were recruited for
the study.
Methods: The study groups had dexamethasone and betamethasone
respectively while the control group had a placebo.
Main outcome: The primary outcome was incidence of respiratory distress
syndrome.
Results: A total of 138 mothers and 146 preterm neonates were included
in the study with 48 exposed to placebo, 49 exposed to betamethasone and
49 exposed to dexamethasone. A pairwise analysis was done to test for
difference between the groups. There was no statistically significant
difference in the incidence of respiratory distress syndrome between the
dexamethasone vs placebo (p= 0.98, RR 1, CI 0.06-16.89), betamethasone
vs placebo (p= 0.98 RR 1, CI 0.09-11.55) and dexamethasone vs
betamethasone (p=0.32, RR 0.5, CI 0.09-2.42)
Conclusion: Antenatal corticosteroids may decrease the need for neonatal
resuscitation at birth in late preterm neonates.
Funding: The research was funded by Tertiary Education Trust Fund
(TETFUND) of Nigeria.
Trial registration: ClinicalTrial.gov, NCT03446937
Keywords: Antenatal corticosteroids, late preterm delivery, neonatal
morbidity.
INTRODUCTION
Preterm birth is a significant cause of neonatal morbidity and
mortality. The use of antenatal corticosteroids before 34 weeks of
gestation has been proven to prevent respiratory distress syndrome and
other morbidities in neonates.(1) However, limited evidence is available
for its use in the late preterm period.(2),(3)
Respiratory distress syndrome is one of the most important causes of
neonatal morbidity and mortality in preterm births. Other causes of
neonatal morbidity and mortality in preterm neonates include
intraventricular haemorrhage, sepsis, periventricular leucomalacia and
necrotizing enterocolitis. In preterm neonates, surfactant
insufficiency, immaturity and poor lung development result in
respiratory distress in preterm infants. As gestation advances, chances
of survival improve due to increasing maturity of the respiratory
system. Black neonates are said to have lower rates of respiratory
distress syndrome compared to non-black neonates.(4) This has been
attributed to qualitative difference in the surfactants and possible
anatomical difference in fetal lung development.(4) Despite this, there
is some evidence that infant mortality due to respiratory distress may
actually be affected by genetics race and ethnicity.(5)
Even though adequate fetal lung maturation for survival is expected to
be achieved by 34 weeks of gestation, neonatal and childhood
complications are still common in preterm neonates delivered after 34
weeks of gestation when compared to those delivered at term. (5),(6),
(7). This led to the recommendation by National Institute Of Child
Health And Human Development during a workshop in 2005 to direct
research to evaluate infants who are born between 34 and 36 weeks
gestation especially with regards to the benefits of use of antenatal
corticosteroids in the population. (8)
This study sought to determine the effect of antenatal corticosteroids
on neonatal respiratory distress syndrome and other neonatal
complications in women at risk of late preterm delivery in our clinical
setting.
METHODS