ARTICLE INFO

Article Type

Original Research

Authors

Saymari   F. (1 )
Zand Vakili   F. (* )
Rezaie   M. (1 )
Mansori   M. (2 )
Afkhamzadeh   A. (3 )






(* ) Obstetrics & Gynecology Department, Medicine Faculty, Kurdistan University of Medical Sciences, Sanandaj, Iran
(1 ) Obstetrics & Gynecology Department, Medicine Faculty, Kurdistan University of Medical Sciences, Sanandaj, Iran
(2 ) Pediatrics Department, Medicine Faculty, Kurdistan University of Medical Sciences, Sanandaj, Iran
(3 ) Family & Social Medicine Department, Medicine Faculty, Kurdistan University of Medical Sciences, Sanandaj, Iran

Correspondence

Address: Obstetrics & Gynecology Department, Be’sat Hospital, Mardoukh Junction, Keshavarz Street, Sanandaj, Iran
Phone: +988733288119
Fax: +988733288119
fr.fzandvakili@gmail.com

Article History

Received:  December  22, 2014
Accepted:  March 1, 2015
ePublished:  April 16, 2015

BRIEF TEXT


… [1-3] Corioamnionitis and microcephaly have been observed with prescription of multiple doses of betamethasone [4, 5]. … [6-8] Glucocorticoids reduce the incidence and severity of respiratory distress syndrome in infants through producing surfactant dependent protein and increasing synthesis of phospholipids [9]. The use of corticosteroids in preterm childbirths reduces 50% of respiratory complications and 40% of mortality [10]. Administration of corticosteroids to the mothers, also, reduces the risk of brain hemorrhage, necrotizing enterocolitis and a number of other significant complications, and reduces hospital stay and the costs [11, 12]. Studies have shown that injection of betamethasone in mothers at risk of preterm delivery is significantly effective in hyaline membrane disease or respiratory distress of newborns [13, 14]. Low dose of the drug is used for the prevention of respiratory distress syndrome and it does not have any significant complications [15]. ... [16]

In a study of 256 mothers of premature infants and by placing three groups including single-dose, double dose and control (no injection), the rate of respiratory distress has not have any significant difference between the two groups of single-dose and double, but it has been significant between these groups and the control group [17]. In the study of mothers of premature infants in the two groups of single-dose and double-dose, no significant difference was observed in terms of respiratory distress, but significant difference was observed between two groups with respect to necrotizing enterocolitis [18].

The aim of this study was to compare the efficacy of single-dose and double-dose treatment with betamethasone in terms of preterm infants’ outcome.

This is a quasi-experimental study in a clinical trial.

Preterm pregnant women admitted in Besat Hospital of Sanandaj (Iran) provided written consent to participate in the study were studied with their infants during 2012.

100 mothers and 103 of their infants (3 women had twins) were selected based on purposive sampling. The sample size based on indicators studied by Fekih et al. [19] was 37 in each group. To increase the accuracy, in each group, 50 pregnant women and their newborns were studied. The samples were non-randomly selected, and they divided into groups of single and double dose of betamethasone based on the clinical conditions of mothers. Inclusion criterion for the study was 26 to 34 weeks of pregnancy. Exclusion criteria of the study were the risk of mother to placental abruption, corioamnionitis, severe preeclampsia syndrome and HELP syndrome.

For mothers, the age, gestational age, and history of premature infants were recorded in a checklist. In the group of single dose, 12mg intramuscular betamethasone was injected, and in the group of double-dose, 12mg betamethasone was injected to the pregnant women every 24 hours. Then, information about the delivery and the infants were recorded and determined in terms of sex, weight and Apgar score. Infants were examined by a specialist in terms of respiratory distress syndrome, necrotizing enterocolitis, intracranial hemorrhage, and neonatal death and assessments were recorded. Data were analyzed using SPSS 20 software. To answer questions, descriptive statistical formula such as the average and ratio were used , and for analysis of assumptions with respect to the scale and type of variable and its distribution, chi-square tests (to compare respiratory distress, sepsis of newborn, enterocolitis, need for hospitalization in the NICU, and the mortality rate in both groups) and Mann-Whitney U test (for comparing the length of stay in the NICU, one and 5-minute Apgar scores between the two groups due to abnormal data) were used. Kolmogorov-Smirnov test showed that the distribution of quantitative variables was not normal.

The mean gestational age was 31.34± 2.44weeks, minimum 24weeks and maximum 35 weeks. Mean age of mothers was 29/75 ± 7/01years, minimum 16years and maximum 48 years. 48 newborn infant (46.6%) were boys and 55 of them (53.4%) were girls. Intraventricular hemorrhage occurred in 11 cases (10.7%) and it did not occur in 96 infants (89.3%). Neonatal sepsis occurred in 7 cases (6.8%) and it did not occur in 96 infants (93.2%). Only one of the women had a history of premature delivery of birth (1.0%), which was in the double-dose group. In terms of gestational age, the age of mother and newborn infants’ weight, no significant difference was observed between single-dose and double-dose group. With respect to the needs of infants to be hospitalized in the neonatal intensive care unit, need for respiratory support and newborn death, there was no significant difference between two groups. In enterocolitis, respiratory distress, intraventricular hemorrhage, and neonatal sepsis, there was no significant difference between single and double dose groups (Table 1). There was no significant difference between the two groups in terms of the mean of Apgar in the minute 1, minute 5 and infant hospitalization days in NICU.

Maternal demographic characteristics were similar in both groups and there was no significant difference. It can be said that the results were not influenced by these characteristics. Many studies have been done regarding the effects of standard treatment (administration of doubled-dose of betamethasone) and this effect has been confirmed in most of them [19-22, 25-27]. However, not many studies have been done in terms of comparing the efficacy of single-dose or double-dose of betamethasone [28, 29]. The difference between the incidence of respiratory distress in single-dose and double-dose with 28.0%, and 24.5% respectively was not significant. There is no significant difference between single and double dose group while there is a significant difference among the groups that have received betamethasone and those who have not received that [17]. Comparison between the effects of betamethasone in both single and double dose group in terms of the incidence of respiratory distress with 35.5% vs. 37.5% respectively shows that the difference is not statistically significant [29], which is consistent with the results of the present study. However, respiratory distress has been higher in the single-dose group compared to double-dose group [30]. The incidence of respiratory distress has been 45% and 35% in single-dose and double-dose groups respectively [31]. Regarding the infant mortality rate in both groups, the incidence was 24.0% in the single-dose group and 18.9% in double-dose group which showed no significant difference, although clinically 5% difference can be important. Comparison between the effects of betamethasone in terms of the rate of mortality shows that there is no significant difference between single-dose and double-dose groups [32]. The results of this study are consistent with the results of other studies [17, 29, 30, 33] and no study was found to be contrary to the findings of this study. The results of the present research is ,also, in line with the studies which have compared between the effects of betamethasone as a standard therapy (prescribing double-dose) and control group (without betamethasone) and have shown a significant reduction in the incidence of mortality [20, 21, 27]. With respect to necrotizing enterocolitis in two groups, with the incidence of 8.0% in single-dose group and 13.2% in double-dose group, no significant difference was observed between the groups although the single-dose group with about 5% of the difference was in better condition which can be clinically important. These results are consistent with the results of other studies [17, 30. 32]. In single-dose group, 6.2% necrotizing enterocolitis has occurred while it has been 0% in the double-doze group which shows a significant difference [29]. This finding is contrary to the finding of the present study. With respect to the need for respiratory support and neonatal infant hospitalization in intensive unit care, no significant difference between the groups was observed, and it was shown that single-dose and double-dose administration of betamethasone have similar effects on respiratory support need hindering and hospitalization in the neonatal intensive care unit. This finding is consistent with other studies [28-31]. In betamethasone standard treatment, the effectiveness of this medication in reducing the need for hospitalization has been confirmed [19, 21, 22, 25]. In terms of the incidence of sepsis in neonates, the difference between single-dose (2%) and double-dose (11.3%) groups was not significant, although there is a minimum relationship and it was 9.3% higher in double-dose group compared to single-dose group. These findings are consistent with other studies [28-30]. The incidence of intraventricular hemorrhage in single and double-dose groups was 8% and 13.2% respectively; the difference of which was not significant. These findings are consistent with other studies [28-30].

Probably, single-dose of betamethasone can be effective on the prevention of necrotizing enterocolitis. Further studies should be done in this regard.

The limitation of this study was non-random selection of the samples.

Single-dose administration of betamethasone in preterm mothers could be an option in preventing poor outcomes for preterm infants to reduce the side effects of betamethasone that some studies have found its negative effects on height and weight of newborns, although more studies are necessary for the ultimate judgment.

Besat Kurdistan University School of Medicine professors of Obstetrics and Gynecology Hospital staff are appreciated.

Non-declared

All procedures were approved by Ethics Committee of Kurdistan University of Medical Sciences.

This project was funded by the Research Deputy of Kurdestan University of Medical Sciences.

TABLES and CHARTS

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