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Absence of significant hemodynamic changes in the fetus following maternal betamethasone administration.

Maternal betamethasone administration causes a transient but considerable reduction in fetal body and breathing movements and in fetal heart rate variation. The aim of the present prospective study was to investigate whether there is evidence of circulatory changes in fetal, placental or uterine arteries, consistent with hypoxemia. Eighteen women at risk for preterm delivery received betamethasone to enhance fetal lung maturation. Doppler studies were performed before treatment, and 24 and 72 h after the second dose of betamethasone. Blood flow velocity waveforms were obtained from both uterine arteries, umbilical arteries, fetal descending aorta, fetal renal artery, and fetal cerebral arteries. No significant changes occurred in the pulsatility index of any of these blood vessels, suggesting that the transient reduction in fetal heart rate variation and fetal body and breathing movements following maternal betamethasone administration is not mediated through fetal hypoxemia.

Adult↗

Changes in fetoplacental vessel flow velocity waveforms following maternal administration of betamethasone.

OBJECTIVE: To determine the timing of the onset of the umbilical artery flow velocity waveform changes following maternal administration of betamethasone in pregnancies complicated by umbilical artery absent end-diastolic flow, and to explore whether these changes are associated with flow velocity waveform changes in other fetoplacental vessels. SUBJECTS AND METHODS: This was a prospective study of 12 women with pregnancies complicated by umbilical artery absent end-diastolic flow. Flow velocity waveforms were recorded from the umbilical artery, fetal middle cerebral artery, renal artery, aorta and ductus venosus, before and after maternal betamethasone administration, using real-time pulsed wave Doppler. RESULTS: In all 12 pregnancies, the administration of maternal betamethasone was followed by the return of end-diastolic flow within 24 h. End-diastolic flow was first observed at 4 h and was present in all women studied at 8 h. In addition, there was a statistically significant decrease in the pulsatility index in the fetal aorta at 8 h and the middle cerebral artery at 24 h. No change was observed in the ductus venosus or the renal artery flow velocity waveforms. CONCLUSION: The findings suggest that, in pregnancies complicated by absent end-diastolic flow in the umbilical artery, maternally administered betamethasone induces a return in umbilical artery end-diastolic flow as early as 4 h, along with widespread vasodilatation throughout the fetoplacental vasculature.

Betamethasone↗

Changes in umbilical artery flow velocity waveforms following maternal administration of betamethasone.

In a retrospective cohort study we have previously shown that administration of betamethasone to women with a pregnancy complicated by absent end-diastolic flow in the umbilical artery (UA) is associated with altered UA flow velocity waveforms. To examine this phenomenon further we undertook a prospective study of 30 similar singleton pregnancies. Umbilical artery FVWs were recorded before and after betamethasone administration using real-time pulsed wave colour flow Doppler. The results of this prospective cohort were similar to those of the retrospective study allowing pooling of the data. Of the 55 total pregnancies with umbilical artery AEDF studied betamethasone administration was associated with the return of end-diastolic flow in 39 (71 per cent; 95 per centCI: 59-83 per cent). The median (range) duration of this change was 3 (1-10) days. There is no evidence that this change has either a beneficial or detrimental effect on foetal health. Administration of betamethasone to women with a pregnancy complicated by umbilical artery AEDF is associated with the transient return of end-diastolic flow in most cases. While the mechanisms underlying this effect are yet to be fully elucidated it has implications for foetal surveillance in these high-risk pregnancies.

Adult↗

[Continuous glucose monitoring using the glucose sensor CGMS in metabolically normal pregnant women during betamethasone therapy for fetal respiratory distress syndrome].

PURPOSE: The object of this study was to evaluate the effect of betamethasone therapy on maternal glucose levels, to observe the incidence of ketoacidosis and gestational diabetes as well as to judge fetal outcome. METHODS: 26 patients underwent measurement with the CGMS for at least 72-hour. Morning urine was examined for ketones and glucose, venous blood was drawn from a hand vein for blood gas measurements. At a minimum of seven days after the last betamethasone treatment, an oral glucose tolerance test was performed to exclude gestational diabetes. For fetal outcome weight, body length, head circumference, APGAR and pH of umbilical cord blood were determined. RESULTS: All patients showed transient hyperglycaemia from day 1 to day 2 with normoglycaemia on day 3 (mean +/- SD: 129.6 +/- 20 mg/dL on day 1, 127.1 +/- 17.7 mg/dL on day 2, 96.7 +/- 12.9 mg/dL on day 3, and 91.3 +/- 17.8 mg/dL on day 4). There was a significant fall (p < 0.01) of the mean glucose levels between day 1/3, day 1/4, day 2/3, day 2/4. Neither acidosis (pH < 7.35) nor clinically relevant BE/lactate shifts were seen. Ketonuria was detected in 30 % of the patients before betamethasone, rose to 50 % (on day 1), fell to 24 % (on day 2), and 6 % (on day 3). One week later one patient (4 %) was diagnosed as having gestational diabetes, while four (17 %) showed impaired glucose tolerance. Fetal outcome showed no significant difference compared to the average of the Virchow Klinikum. CONCLUSION AND DISCUSSION: Pregnant patients have high glucose measurements for two days during betamethasone therapy. No maternal acidosis and no diabetic delayed metabolic effects were seen, and fetal outcome showed good results. A prophylactic use of insulin is not generally needed in healthy women.

Adult↗

Comparison of the analgesic effect of betamethasone and diclofenac potassium in the management of postoperative haemorrhoidectomy pain.

BACKGROUND: Outpatient postoperative haemorrhoidectomy pain remains a difficult problem. The purpose of this study is to compare the results of the use of betamethasone with diclofenac potassium in postoperative pain following haemorrhoidectomy. MATERIAL AND METHODS: Closed haemorrhoidectomy was performed on 40 patients who were diagnosed grade III, grade IV haemorrhoid on physical examination. Patients were divided equally randomized into two groups, prospectively (betamethasone was used for 20 patients and diclofenac potassium was given for 20 patients). A verbal categorical scale was used to evaluate postoperative pain (for pain intensity, none=0, mild=1, moderate=2 and severe=3). RESULTS: The amount of narcotics required on postoperative first, second and third day were significantly less in the betamethasone group than in the diclofenac potassium group (P < 0.001) (Pearson Chi-Square test). CONCLUSION: Results indicate that use of betamethasone provides more effective analgesia than diclofenac potassium for postoperative pain management in the haemorrhoidectomy patient.

Administration, Oral↗

Visual interpretation of the effect of maternal betamethasone administration on the fetal heart rate pattern.

This study was performed to interpret visually the effect of maternal betamethasone administration on the fetal heart patterns in women at risk for preterm delivery. These effects had previously only been described using computer analysis. It was a retrospective study of 54 women who had received two doses of betamethasone 12 hours apart and had fetal heart tracings before, and on the first and second days after steroid administration. The primary outcome measure was change in short-term variability and secondary outcome measures were change in long-term variability, baseline fetal heart rate, accelerations and decelerations. Inter-observer variation of fetal heart rate variability was also measured. Betamethasone caused a significant reduction in short-term variability 1 and 2 days after administration. There was no effect on baseline fetal heart rate or on variable decelerations. A transient decrease in fetal heart rate accelerations was observed on the first day after steroid administration but not on the second day. Inter-observer variability was good between the two observers (GJH and BVI). In most clinical settings, surveillance of fetal wellbeing is achieved most commonly by visual inspection of the fetal heart tracings and not by computer analysis. Clinicians should be aware of the effects of betamethasone on these tracings when considering interventions and/or other tests of fetal wellbeing.

Adolescent↗

Systemic effects of a short course of betamethasone compared with high-dose inhaled budesonide in early childhood asthma.

Forty children aged 1-3 y completed a placebo-controlled study on the effects of 10 d of inhaled budesonide for asthma caused by respiratory tract infection. The effects on symptoms were significantly better in the active than in the placebo group. In 20 of these children the systemic effects of high-dose inhaled budesonide for 10 d and the effect of a 3-d course of oral betamethasone on asthma exacerbation were evaluated. Systemic effects were evaluated by measuring morning cortisol in serum and urine, and the bone markers osteocalcin, ICTP (the C-terminal telopeptide region of type I collagen) and PIIINP (an N-terminal propeptide of type III procollagen) in serum before and at the end (d 7-10) of treatment (1600 microg budesonide d(-1) for 3 d and 800 microg for 7 d). In 9 children, measurements were taken on d 3 of a 3-d course of betamethasone (6, 4 and 2 mg) for asthma exacerbation and 14 d later. There were no signs of systemic effects after 7-10 d of budesonide. After 3 d of betamethasone, serum cortisol decreased from a median of 263 to 26 nmol l(-1), urine cortisol/creatinine from 19.9 to 7.2 nmol l(-1), osteocalcin from 31.4 to 5.5 microg l(-1), ICTP from 19.4 to 8.5 microg l(-1) and PIIINP from 12.3 to 5.9 microg l(-1). Two weeks later, the levels were back to normal. In conclusion, short courses of oral betamethasone have pronounced systemic effects, whereas 10 d of high doses of budesonide do not produce significant systemic effects.

Asthma↗

A randomized controlled trial to compare calcipotriol with betamethasone valerate for the treatment of cutaneous lichen planus.

BACKGROUND: Topical calcipotriol is a vitamin D3 analogue which influences keratinocyte proliferation and differentiation. Its efficacy in cutaneous lichen planus has not been well evaluated. METHODS: This is a randomized open-label trial comparing the effectiveness of calcipotriol 50 microg/g versus betamethasone 0.1% ointments twice daily for 12 weeks in patients with cutaneous lichen planus, with respect to thickness, pigmentation, clearance and pruritus. Patient self-assessment was made at 0, 4, 8 and 12 weeks post randomization using visual analogue scales (VAS). Clinical assessment was made at week 12 and adverse events noted. Clinical response was defined as 75% or more for lesion flattening and absent or minimal pigmentation, and 50% or more for clearance. RESULTS: A total of 31 patients were randomized: 15 to calcipotriol and 16 to betamethasone. Clinically assessed lesion flattening occurred in approximately half the patients. With calcipotriol, there were two responses for pigmentation and one for clearance but none with betamethasone. Patient VAS indicated a gradual improvement in all measures but with little difference between the treatments. The largest difference indicated a 12-point disadvantage to calcipotriol for thickness but this was not statistically significant (p=0.09). Side effects reported were erythema (one patient) and increased pruritus (two patients), all with calcipotriol. CONCLUSION: Calcipotriol appears no more effective than betamethasone. The course of the disease appears to be affected in the same way by both treatments.

Administration, Cutaneous↗

Multiple courses of antenatal betamethasone and cognitive development of mice offspring.

OBJECTIVE: To measure the effect of multiple courses of antenatal betamethasone, used for lung maturation, on long-term cognition of mice offspring. METHODS: Forty gravid CD-1 mice were randomly assigned to receive one of four treatments (n = 10 per group): 0.1 mg betamethasone or saline placebo, given subcutaneously either once daily on gestational days 13-16 or twice daily on days 14 and 15. This dose of betamethasone given on gestational day 14 causes fetal lung maturation in mice. Three offspring per gender in each litter underwent standard cognitive tasks as juveniles and as adults. Analysis of variance or Kruskal-Wallis testing was used to compare data. RESULTS: Learning acquisition and memory were indistinguishable between the betamethasone-exposed and the corresponding placebo-exposed offspring when performing the following tasks: juvenile runway with adult memory, adult water runway and Morris spatial maze. This lack of difference in task performance between treatment groups persisted after controlling for gender and for each multiple-course regimen. CONCLUSION: Multiple courses of antenatal corticosteroids did not impact the mouse offsprings' long-term learning and memory.

Animals↗

Drug-induced Cushing syndrome in a patient with ulcerative colitis after betamethasone enema: evaluation of plasma drug concentration.

The authors report the induction of Cushing syndrome by daily betamethasone enema in a patient with ulcerative colitis, and they determine for the first time the pharmacokinetic profile of betamethasone after rectal dosing. The authors found high plasma concentrations of betamethasone, which could have been enough to cause Cushing syndrome. Suppression of the hypothalamus-pituitary-adrenal axis disappeared after the dose schedule was changed from every day to three times a week. These findings suggest that a considerable amount of betamethasone is absorbed after rectal dosing.

Administration, Rectal↗

Short-term outcomes in low birth weight infants following antenatal exposure to betamethasone versus dexamethasone.

OBJECTIVE: To assess the incidence of short-term outcomes of low birth weight infants (</= 1,750 g) exposed prenatally to either dexamethasone or betamethasone. METHODS: We retrospectively analyzed a cohort comprising 550 infants who were born alive at our center during the period January 1999 through December 2001, who weighed 1,750 g or less at birth, and who were exposed to prenatal steroid treatment. We compared brain ultrasound findings, such as intraventricular hemorrhage and cystic periventricular leukomalacia (PVL), as well as other clinical findings, including respiratory distress syndrome (RDS), necrotizing enterocolitis, retinopathy of prematurity, and bronchopulmonary dysplasia, for all premature infants whose mothers received either dexamethasone (from January 1, 1999 to June 30, 2000, n = 263) or betamethasone (July 1, 2000 to December 31, 2001, n = 287). RESULTS: Patient characteristics (mothers and infants) were the same in both groups, with the exception of the number of steroid courses administered, the number of women with premature rupture of membranes (defined as > 24 hours), and the number of women who had received tocolysis. No significant difference was found between the 2 groups with respect to intraventricular hemorrhage and cystic PVL frequencies. No significant differences were found in the incidence of short-term outcomes examined, despite the fact that the dexamethasone group was exposed to a statistically significantly greater number of courses than the betamethasone group. CONCLUSION: There seem to be no advantages to maternal antenatal treatment with betamethasone compared with dexamethasone in reducing the risk of PVL in low birth weight (</= 1,750 g) infants. Both drugs have the same effect on all short-term outcome parameters checked.

Betamethasone↗

Oral betamethasone versus intramuscular dexamethasone for the treatment of mild to moderate viral croup: a prospective, randomized trial.

OBJECTIVE: Intramuscular dexamethasone is an effective, but painful, treatment for croup. The effectiveness of betamethasone, an oral, palatable, and equally potent glucocorticoid has not been studied. The purpose of this study was to compare the effectiveness of a single oral dose of betamethasone with intramuscular dexamethasone in the outpatient treatment of mild to moderate croup. METHODS: Children aged 6 months to 6 years presenting to a tertiary care pediatric emergency department (ED) with a modified Westley croup score of 0 to 11 were randomized to receive either 0.6 mg/kg IM dexamethasone or 0.4 mg/kg PO betamethasone. Croup score, heart rate, respiratory rate, pulse oximetry, and need for supplemental treatments were recorded at study entry and at 1, 2, and 4 hours after treatment. Follow-up data were collected by daily telephone follow-up on persistence of symptoms and the need for additional treatment or physician visits up to 7 days after the ED visit. RESULTS: Each study group contained 26 patients. Despite randomization, the mean baseline croup score was higher in the dexamethasone group (3.6 +/- 2.6 vs. 2.0 +/- 2.4, P = 0.03). Patients in both groups showed a significant reduction in the croup score after treatment, and there were no significant differences between croup scores at 4 hours (P = 0.18). Similarly, there were no differences between groups in the hospital admission rate, time to resolution of symptoms, need for additional treatments, or number of return ED visits. CONCLUSION: There is no difference between oral betamethasone and intramuscular dexamethasonein the management of mild to moderate viral croup. It is palatable and does not require a nurse for administration, making it a good alternative for ambulatory management.

Administration, Oral↗

Epidermal cytokeratin and immunocyte responses during treatment of psoriasis with calcipotriol and betamethasone valerate.

Changes in epidermal immunocytes and cytokeratins were investigated during treatment of psoriasis with calcipotriol and betamethasone valerate. Skin biopsies were obtained from 10 subjects on each treatment from lesional and non-lesional skin at baseline, and from treated lesions after 4 weeks. In each subject, changes in expression of cytokeratins K5, K10 and K16, and changes in epidermal immunocyte counts were assessed. Responses were compared with a separate histological parameter of improvement, epidermal thickness. Both treatments produced a marked normalization of cytokeratins. The reduction of K16 expression was similar on each treatment and correlated significantly with reduction in epidermal thickness. Expression of both K5 and K10 improved less than thickness with betamethasone valerate but more than thickness with calcipotriol, although these differences did not reach statistical significance. With calcipotriol there was an increase in K5 and K10 responses with increasing response of epidermal thickness, which was not seen with betamethasone valerate. T6+ cells, HLA-DR+ dendritic cells and T lymphocytes were all reduced by betamethasone valerate. There was a remarkable similarity in the level of normalization between cell types and also between cellular response and reduction in thickness. Calcipotriol produced a similar consistent reduction in cell numbers and in thickness, with the exception of T6+ cells which increased in some subjects during treatment. Only in subjects in whom thickness had virtually returned to normal was there a marked decrease in T6+ cells.

Adult↗

Consistency of data in six phase III clinical studies of a two-compound product containing calcipotriol and betamethasone dipropionate ointment for the treatment of psoriasis.

BACKGROUND: Calcipotriol and betamethasone dipropionate are both proven products in the topical treatment of psoriasis. The efficacy and tolerability of a new ointment containing these two compounds has been assessed in six phase III clinical studies. OBJECTIVE: To compare the results obtained in the clinical studies of the new calcipotriol/betamethasone dipropionate ointment. METHODS: A total of 6050 patients with psoriasis took part in the six randomized, double-blind studies. The two-compound product was compared with each of the active constituents, either in the new ointment vehicle or in the marketed formulation. RESULTS: After 4 weeks of treatment the mean reduction in the Psoriasis Area and Severity Index (PASI) ranged from 65 to 74% with the two-compound product applied once or twice daily, from 46 to 59% with calcipotriol alone and from 57 to 63% with betamethasone dipropionate alone. The tolerability profile of the two-compound product was similar to betamethasone dipropionate monotherapy and better than calcipotriol alone. CONCLUSION: The new two-compound product containing calcipotriol and betamethasone dipropionate was found to consistently provide rapid, highly effective treatment of psoriasis vulgaris.

Adult↗

Antenatal administration of betamethasone to prevent respiratory distress syndrome in preterm infants: report of a UK multicentre trial.

In a prospective, randomized, double-blind, multicentre trial the effect of antenatal treatment with betamethasone phosphate was compared with placebo in the prevention of the respiratory distress syndrome (RDS) in preterm infants. The dose of betamethasone was 4 mg every 8 h for six doses, unless delivery occurred. The 251 women who were enrolled gave birth to 262 liveborn infants, 130 in the beta-methasone and 132 in the placebo group; the two groups were evenly matched in most respects. The diagnosis of RDS in the newborn was confirmed by two independent assessors. Seven of the 130 infants in the betamethasone group and 16 of the 132 in the placebo group developed RDS. In infants whose mothers had received at least three injections, RDS was also less frequent in the steroid group than in the placebo group (3/104 and 10/104 respectively; P less than 0.05). There was a significant reduction of RDS in those born between 24 h and 6 days after entry into the trial (0/30 and 8/45 respectively; P less than 0.05). The largest difference in frequency of RDS occurred in the subgroup of infants born before 34 weeks gestation, within 8 days of trial entry, and whose mothers had received at least three injections (0/27 steroid group and 7/32 placebo group; P = 0.03), and there were also significantly fewer neonatal deaths (2/27 and 13/32, respectively; P less than 0.01) in this subgroup. Betamethasone did not provoke earlier delivery. Premature rupture of the membranes and maternal hypertension did not seem to contraindicate the use of steroids: there was no increase in maternal or neonatal sepsis nor in stillbirth in hypertensive pregnancies in the steroid group. Neonatal jaundice was significantly less frequent in the steroid (55/129) than in the placebo group (81/127; P less than 0.01) but not in the subgroups born before 34 completed weeks gestation.

Betamethasone↗

A randomised controlled comparison of betamethasone with dexamethasone: effects on the antenatal fetal heart rate.

OBJECTIVE: To compare the effects of maternal administration of betamethasone and dexamethasone on fetal heart rate, using computerised numerical analyses, and to examine the association between changes in short term variation and the timing and indication for delivery. SETTING: John Radcliffe Hospital, Oxford. SAMPLE: Fifty-nine women with singleton pregnancies, who were at risk of delivery before 34 weeks of gestation, had received no steroids in the preceding week and could give informed consent. METHODS: Women were randomised on a double-blind basis to receive either betamethasone or dexamethasone. The fetal heart rate was recorded (60-minute duration at similar times of day) before steroid administration and on each of the following two days; changes were measured by computerised analyses. MAIN OUTCOME MEASURES: Changes in short term variation and long term variation of fetal heart rate or the number of fetal movements. Statistical analysis was nonparametric. RESULTS: Betamethasone and dexamethasone had no differential effects on the computerised cardiotocography. However, both steroids decreased baseline fetal heart rate, increased long term variation, increased short term variation, and decreased fetal movements on the first day after steroid administration, and decreased high fetal heart rate variation and decelerations on the second day. Among 13 women who were delivered within one week of steroid administration, smaller rises in short term variation on day one were associated with delivery for fetal indications. CONCLUSIONS: Both betamethasone and dexamethasone produced transient, unexplained changes in the fetal heart rate over the two days following steroid administration. Larger changes in short term variation were associated with fetal wellbeing. It is important to recognise that such changes are a physiological response of the human fetus to steroid administration.

Adult↗

Corticosteroids and fetal vasculature: effects of hydrocortisone, dexamethasone and betamethasone on human umbilical artery.

OBJECTIVE: To investigate the direct effects of corticosteroids on human umbilical artery resistance, in vitro. DESIGN: Prospective laboratory study. SETTING: University teaching hospital. SAMPLES AND METHODS: Umbilical artery samples were obtained following normal, term deliveries (n = 50) and dissected rings were suspended for isometric recording under physiological conditions. The effects of hydrocortisone (10(-9) - 10(-4) M), dexamethasone (10(-9) - 10(-4) M) and betamethasone (10(-9) - 10(-4) M) on umbilical artery resistance were measured in vitro. MAIN OUTCOME MEASURES: Changes in umbilical artery resistance, in vitro. RESULTS: Hydrocortisone (n = 12) exerted a vasodilatory effect on human umbilical artery at all concentrations studied compared with vehicle control experiments (n = 12) (P < 0.0001). The mean net relaxant effect of hydrocortisone ranged from 11.77% (10(-9) M) to 57.01% (10(-4)). Both exogenous compounds, dexamethasone (n = 12) and betamethasone (n = 12), similarly exerted a significant relaxant effect on human umbilical artery tone (P < 0.05-0.01), compared with vehicle control experiments (n = 12). The mean net relaxant effect of dexamethasone ranged from 14.43% (10(-9) M) to 38.12% (10(-4)) and that of betamethasone ranged from 6.02% (10(-9) M) to 42.30% (10(-4)), in a cumulatively increasing fashion. There was a non-significant trend towards a greater vasodilatory effect of dexamethasone than betamethasone at lower bath concentrations studied. CONCLUSION: Corticosteroids exert a direct and potent vasodilatory effect on human umbilical artery resistance in vitro, thus providing an explanation for the previously unexplained vascular effects associated with antenatal administration of corticosteroids.

Adolescent↗

Stable vitiligo treated by a combination of low-dose oral pulse betamethasone and autologous, noncultured melanocyte-keratinocyte cell transplantation.

BACKGROUND: Various surgical procedures are in use to treat stable vitiligo. The possibility of Koebner phenomenon always exists with surgical treatment. Partial or complete failure to repigment is observed in spite of clinical stability. AIM: To evaluate the usefulness of a combination treatment of low-dose oral betamethasone and melanocyte-keratinocyte transplantation. METHODS: Oral betamethasone was given to patients who failed to respond either completely or partially to melanocyte-keratinocyte cell transplantation, and the procedure was repeated for previously treated and nontreated area. A simpler and modified method described by Mulekar was performed. RESULTS: Seventeen patients with vitiligo vulgaris and eight patients with segmental vitiligo were retransplanted after giving oral betamethasone for 2 to 10 months after the initial procedure. Two patients of vitiligo vulgaris and one of segmental vitiligo failed to respond completely even after repeat transplantation. Fifteen vulgaris and seven segmental patients showed excellent to good repigmentation after repeat transplantation. CONCLUSION: Combined treatment of oral betamethasone and melanocyte cell transplantation has a potential to produce complete repigmentation in patients with large vitiliginous areas.

Adolescent↗