Effectiveness Of Antenatal Corticosteroids In Reducing Perinatal Morbidity And Mortality In Late Preterm Births-A Randomized Control Trial

Abstract

Introduction: Antenatal corticosteroids are simple,cheap,effective ,safe and an acceptable intervention whose efficacy is known since 1972 ,the time when Howie and Liggins demonstrated its effect on fetal lung maturity. In 1994 NIH concluded that antenatal corticosteroids should be used from 24-34 weeks of period of gestation in cases of preterm delivery to reduce the rate of respiratory distress.Currently there is no clear cut consensus regarding its use in late preterm. To find if a possible extension of its beneficial effects extends beyond 34 weeks is the aim of this study. Patients who do not have access to tertiary care centre and deliver in this period can benefit from this intervention thus reducing a considerable load on health care. Objective: The objective of this prospective randomized trial is to determine the effectiveness of antenatal corticosteroids in reducing perinatal morbidity and mortality in late preterm births(34-36 weeks of gestation with risk of imminent premature delivery). Methodology: Design: A Prospective Randomized Controlled Trial. Setting: KLE University’s Dr. Prabhakar Kore Hospital and Medical Research Center, Attached to Jawahar Lal Medical College, Belgavi. Subjects: 200 patients who were consenting and fulfilling the inclusion criteria were randomized.105 patients were randomized in group A and 95 in group B.11 patients were excluded as 9 patients in group A delivered before 24 hours of administration of 1st dose of steroid,1 patient in group B had antepartum haemorrhage after randomization and another 1 patient in group B went against medical advice..Finally,96 patients were analyzed in group A and 93 in group B. Intervention: Cases were randomized into 2 groups by SNOSE method of Randomization. Those enrolled in Group A (n=96) were given Inj. Betamethasone 12mg i.m. 2 doses 24 hour apart. Those enrolled in Group B (n=93) were not given steroids. All the data pertaining to administration time and date of steroids, interval between administration and delivery, mode of delivery, intrapartum events and if a caesarean section was done then its indication, was documented and recorded . After delivery all neonates were assessed for the following outcomes-Perinatal mortality,Gestational age at birth,Birth weight in kgs,Apgar score At 1 and 5 minutes ,Admission to NICU and indication of NICU admission which included respiratory distress syndrome,transient tachypnoea of newborn,pneumonia,requirement of phototherapy,sepsis in the first 48 hours of life and duration of stay in NICU. Results: The mean maternal age and gestational age at enrollment was comparable in both the groups.There was a significant difference p=0.023 in parity with 54.17% being primigravida and 45.83% being multigravida in steroid group as compared to 37.63% being primigravida and 62.37 % being multigravida in nonsteroid group. There was no perinatal mortality in both the groups. The gestational age at delivery was comparable in both the groups with mean gestational age being 35.375±0.85 in steroid group vs 35.00±0.83 in nonsteroid group.p=0.363. Mean birth weight was 2.28 ±0.63 kg being in steroid group and 2.24±0.55kg in nonsteroid group(p=0.6888).Apgar score at 1 minute was comparable in both the groups with Apgar score<7 being in 59.38% in steroid group and in 61.29% in nonsteroid group. (p=0.452). Apgar score <7 at 5 minutes was present in 26.04% of patients in steroid group and 33.33% in nonsteroid group.(p=0.272). No statistically significant difference was found in rate of RDS with 8.33% being in steroid group and 7.53% being in nonsteroid group. (p=0.838).19.79% of patients had TTN when compared to 24.73% in nonsteroid grout(p=0.485).No cases of pneumonia were found in either group.The requirement of phototherapy was present in 34.38% of neonates in steroid group and 32.28% of neonates in nonsteroid group(p=0.875).Systemic infections in the first 48 hours were acquired by 12.50% of neonates in steroid group and 9.68% of neonates in nonsteroid group. (p=0.537) . Mean stay in NICU was 6.80±3.67 days in the steroid group as compared to 8.80±4.88 days in the nonsteroid group which was statistically significant with p=0.031 Conclusion: Antenatal corticosteroid administration are cost effective ,simple, acceptable ,safe intervention to prevent perinatal morbidity and mortality in preterm babies.But a possible extension of this benefit in late preterm was the objective of our study and was evaluated. There is no significant difference between the gestational age at delivery, birth weight and Apgar score in the neonates who had received steroid than who did not receive steroid and delivered in late preterm. Rate of NICU admission and indication of admission including respiratory distress syndrome, transient tachypnoea of newborn, pneumonia, requirement of phototherapy ,sepsis in first 48 hours and duration of stay in NICU were assessed and no statistical significance was found between the group receiving steroid and the group not receiving steroid except in the duration of stay in NICU. Thus it is concluded that antenatal corticosteroid administration ,did not reduce the rate of perinatal morbidity and mortality except the mean duration of stay in NICU, in women admitted in late preterm gestation and at risk of imminent premature delivery