American Journal of Obstetrics and Gynecology (2005) 193, 1591–8

www.ajog.org

EDITORS’ CHOICE

Dexamethasone treatment does not improve the outcome

of women with HELLP syndrome: A double-blind,
placebo-controlled, randomized clinical trial
Javier E. Fonseca, MD, MSc,a,b,c Fabián Méndez, MD, PhD,a Claudia Cataño, MD,b,c
Fernando Arias, MD, PhDd

School of Public Healtha and School of Medicine,b Universidad del Valle; Department of Gynecology and Obstetrics,
Hospital Universitario del Valle,c Cali, Colombia; Department of Obstetrics and Gynecology, The Toledo Hospital,
Medical College of Ohio, Toledo, OHd

Received for publication March 15, 2005; revised April 4, 2005; accepted July 5, 2005

KEY WORDS Objective: The purpose of this study was to determine the efficacy of dexamethasone for
Dexamethasone treatment of HELLP (hemolysis, elevated liver enzymes and low platelet count) syndrome.
HELLP (hemolysis, Study design: A prospective, double-blind clinical trial was conducted among 132 women with
elevated liver HELLP syndrome who were assigned randomly to treatment or placebo groups. Pregnant women
enzymes and low in the experimental group received 10-mg doses of dexamethasone intravenously every 12 hours
platelet count) until delivery and 3 additional doses after delivery. Puerperal women received 3 10-mg doses of
syndrome dexamethasone after delivery. The same schedule was used in the placebo group. The main
Clinical trial outcome variable was the duration of hospitalization. In addition, we evaluated treatment effects
on the time to recovery of laboratory and clinical parameters and on frequency of complications.
Results: The mean duration of hospitalization of patients who received dexamethasone therapy
was shorter than in the placebo group (6.5 vs 8.2 days), but this difference was not statistically
significant (P = .37). No significant differences were found in the time to recovery of platelet
counts (hazard ratio, 1.2; 95% CI, 0.8-1.8), lactate dehydrogenase (hazard ratio, 0.9; 95% CI, 0.5-
1.5), aspartate aminotransferase (hazard ratio, 0.6; 95% CI, 0.4-1.1) and to the development of
complications. The results were found in both pregnant and puerperal women.
Conclusion: The results of this investigation do not support the use of dexamethasone for
treatment of HELLP syndrome.
Ó 2005 Mosby, Inc. All rights reserved.

Multisystemic abnormalities that are associated with

Supported in part by the Valle State Secretariat of Health; the
dexamethasone and placebo were provided by Organon Laboratories,
The Netherlands.
Reprints not available from the authors. Address correspondence to
Javier E. Fonseca, Universidad del Valle, Obstetrics and Gynecology,
Hospital Universitario del Valle, Cali, Valle 57, Colombia.
E-mail: jfonseca@univalle.edu.co
adverse maternal and fetal outcomes have been recog-
nized for many years in women with preeclampsia1-3;
HELLP (hemolysis, elevated liver enzymes and low
platelet count) syndrome4 is one of its most dangerous
presentations.5 Women with HELLP syndrome may be
classified by the degree of thrombocytopenia into

0002-9378/$ - see front matter Ó 2005 Mosby, Inc. All rights reserved.
doi:10.1016/j.ajog.2005.07.037
1592
HELLP 1 (%50,000 platelets/mm3), HELLP 2 (between
50,000 and 100,000 platelets/mm3), and HELLP 3 (be-
tween 100,000 and 150,000 platelets/mm3).6
Treatment of HELLP syndrome usually is restricted
to measures of support and treatment of complications.
However, since a first report in 1993,7 several clinical
trials have suggested that corticosteroids, mainly dexa-
methasone therapy, can ameliorate and stabilize the
disease in the antepartum period and accelerate recovery
after delivery.8-11 However, these studies were not dou-
ble-blind or placebo-controlled trials and had small
sample size, and there is a definite need for additional
randomized clinical trials.5 For this reason, we con-
ducted a study that was aimed to determine the efficacy
of dexamethasone for the treatment of HELLP
syndrome classes 1 and 2.
Material and methods
This was a double-blind, placebo-controlled randomized
clinical trial that involved pregnant and puerperal
women who were admitted to the Hospital Universitario
del Valle in Cali, Colombia, between October 2001 and
September 2003. Women who were at O20 weeks of
gestation or during the first 3 days of puerperium were
asked to participate in the study if hypertension devel-
oped during the pregnancy or the puerperium and met
the criteria for complete HELLP syndrome as defined
by Sibai12: platelet count, %100,000/mm3; aspartate
aminotransferase (AST), O70 U/L; lactate dehydrogen-
ase (LDH), O600 U/L. Exclusion criteria were oral
temperature O37.5(C and diabetic ketoacidosis. Be-
cause of the potential for spontaneous recovery, puer-
peral women were excluded if randomization was not
accomplished in the first 24 hours after diagnosis. The
study was approved by the Institutional Review Boards
of the Hospital and the Medical School.
Pregnant and puerperal women were assigned ran-
domly to treatment or placebo groups, with the use of
stratified and random permuted blocks of 4. The
assignment was kept inside consecutively numbered
opaque envelopes that were labeled as pregnant or
puerperal and that were opened after informed consent
had been obtained. Pregnant women in the experimental
group received 10-mg doses of dexamethasone sodium
phosphate (Oradexon) intravenously every 12 hours
until delivery and 3 additional doses after delivery.
Puerperal women received 3 10-mg doses after delivery.
The same schedule was used in the control group to
administer sterile water as placebo. Dexamethasone and
placebo were packed in identical vials in sealed boxes
that were labeled with the corresponding treatment
codes. Codes were not broken until the end of the
univariate analysis. Treatment was to be discontinued if
oral temperature rose above 37.5(C.
Fonseca et al
All patients received 1 to 1.5 g/hr of magnesium
sulfate intravenously. Nifedipine, 10 mg orally every
6 hours, was administered to women with diastolic
arterial pressure O100 mm Hg. Another antihyperten-
sive medication (clonidine and amlodipine) was admin-
istered if the diastolic pressure remained elevated. In
addition, patients received 1000 mL of normal saline
solution during the first 2 hours and 1000 mL of normal
saline solution every 6 hours afterwards. If the urinary
output remained !30 mL/hr, an additional 500 mL of
normal saline solution was given during 1 hour; if
oliguria persisted, 20 mg of furosemide was adminis-
tered intravenously. Renal failure was diagnosed if the
serum creatinine level was O1.5 mg/dL and if pulmo-
nary edema was diagnosed by physical examination and
chest radiography. When surgery was indicated, 8 units
of platelets were transfused to women with platelet
counts !50,000/mm3. Because the standard of care of
the community is interruption of pregnancy after diag-
nosis of HELLP, induction of labor or cesarean delivery
were performed, depending on the maternal and fetal
condition. If the gestational age was between 26 to 34
weeks, betamethasone (12 mg intramuscularly) was
given every 24 hours for up to 2 doses before delivery.
Withholding steroids was considered unacceptable by
the investigators and the Institutional Review Board.
Duration of hospitalization was measured from ran-
domization to discharge. The duration of hospitaliza-
tion of the 4 maternal deaths was excluded for the
calculation of mean and median but was included and
treated as censored data in survival analysis. Criteria for
discharge included a platelet count O100,000/mm3,
regardless of AST or LDH levels. However, if evidence
of organ damage or other clinical complications was
present, the patients remained in the hospital until
recovery.
Measurements of blood pressure and urine output
were carried out every 2 hours. Baseline and follow-up
laboratory studies included platelet count, AST, LDH,
and serum creatinine measurements every 12 hours.
Platelet counts were performed by automated counting;
LDH and AST were processed at 25(C, with a reference
pattern of 120 to 240 U/L and 0 to 18 U/L, respectively.
Medical personnel were trained on protocol proce-
dures for enrollment and follow-up of patients. Quality
checks of clinical and laboratory forms were carried out
before data entry. After entry, programs were run to
verify the consistency of responses within each ques-
tionnaire. Any detected inconsistencies were resolved by
correction against original data sheets.
Sample size was calculated by the duration of hospi-
talization, as defined earlier.13 We assumed an average
hospital stay of 6 days in the control group and
considered as significant a 33% decrease in stay for
the experimental group, with a significance level of .01
and a power of 90%. The required sample size was
Fonseca et al
Figure 1
67 subjects per group. Analysis was carried out on the
basis of intention to treat. A planned subgroup analysis
was performed according to pregnant and puerperal
strata. An additional, unplanned subgroup analysis was
conducted by severity of clinical presentation at diag-
nosis. We carried out an interim analysis, at a sample
size of 50 individuals, with no differences with final
results. Continuous variables were analyzed with un-
paired t-test or Mann-Whitney test, according to their
distribution. If needed, transformations were carried out
to allow for normal based statistics. Time to recovery of
laboratory parameters (platelets, LDH, and AST) and
duration of hospitalization was analyzed by Kaplan-
Meier. Categoric variables were compared by chi-
squared test or Fisher’ s exact test. Multivariate analysis
1593
Trial profile.
was performed with linear, logistic, or Cox regression,
correspondingly. In addition to treatment (ie, the expo-
sure of interest), other variables were considered in the
final model if their probability values were !.2 in the
univariate analysis.14-16 Antepartum use of betametha-
sone up to 2 weeks before randomization was also
considered during modeling. Where appropriate, results
are presented as relative risk with 95% CI, odds ratio,
and hazard ratio.
Results
A total of 144 patients were considered eligible and were
invited to participate in the study. Two patients (1.4%)
were excluded because of fever, and 2 patients (1.4%)
1594 Fonseca et al

Table I Baseline characteristics Table II Duration of hospitalization according to treatment

Therapy Duration of
Placebo Dexamethasone hospitalization (days) Placebo (66) Dexamethasone (66)
Characteristic (n = 66) (n = 66) Mean (D.S.) 8.2 (12.55) 6.5 (9.66)
Age (y)* 26.2 G 7.20 24.5 G 7.00 Median 4 4
Gestational age (wk)* 33.5 G 4.20 33.8 G 4.50 Range 2-89 2-64
Parity (n)* 2.0 G 2.06 1.2 G 1.25 Interquartile range 3-8 3-6
Platelets (n/mm3)* 58,446 G 21,053 61,171 G 18,912 Difference of mean: 1.7 (
2.28-5.61), P = .37
AST (U/L)* 492 G 579 573 G 621
Alanine 229 G 251 281 G 300
aminotransferase
median values of 57,798/mm3 and 59,200/mm3, respec-
(U/L)*
LDH (U/L)* 2,242 G 1,671 2,124 G 1,849 tively. The mean LDH was 2183 U/L, with a median of
Total bilirubin 3.7 G 4.67 3.3 G 3.20 1701 (range, 623-12,600); the mean AST was 532 U/L,
(mg/mL)* with a median of 280 (range, 71-2870). Baseline charac-
Creatinine (mg;/mL)* 0.9 G 0.53 0.9 G 0.49 teristics according to study groups were similar (Table I).
Urinary 85 G 65.50 92 G 59.70
output (mL/min)*
Systolic pressure 141 G 21.01 145 G 21.00 Duration of hospitalization
(mm Hg)*
Diastolic pressure 93 G 13.40 93 G 12.61 The distribution of duration of hospitalization was
(mm Hg)* transformed (1/duration of hospitalization) to allow
the use of statistical methods that are based on the
Qualitative protein in urine (n)
Gaussian distribution. The mean duration of hospital-
Positive 57 (87.36%) 55 (83.33%)
Negative 4 (6.06%) 4 (6.6%) ization was shorter among patients who received dexa-
Unknown/ 5 (7.58%) 7 (10.61%) methasone therapy; however, this difference was not
unavailable statistically significant. Median and interquartile ranges
Acute renal 4 (6.06%) 6 (9.09%) also were found to be no different (Table II). The
failure at univariate and multivariate analysis showed that a
enrollment longer duration of hospitalization was associated with
Pulmonary edema 1 (1.52%) 1 (1.52%) a lower urinary output (!30 mL/h) and higher LDH
HELLP class at enrollment (n) levels. Survival analysis of time to discharge showed
HELLP 1 28 (42.42%) 21 (32.31%) no differences (Figure 2,A; hazard ratio, 1.3; 95% CI,
HELLP 2 38 (57.58%) 44 (67.69%) 0.9-1.9).
Steroid use up to 2 weeks before delivery (n)
No 44 (66.67%) 48 (72.73%)
Time to recovery of laboratory tests
Yes 21 (31.82%) 16 (24.24%)
Unknown 1 (1.52%) 2 (3.03%) There was no statistically significant difference between
* Data are given as mean G SD. dexamethasone-treated and placebo-treated patients
with respect to the time that was required to achieve a
platelet count of O100,000/mm3 (Figure 2,B; Table III).
declined to participate. Eight puerperal women (5.5%) Recovery of the platelet count was more likely to occur
were not allocated to treatment during the first 24 hours among patients with urinary output at enrollment of
after diagnosis and were also excluded. After these ex- O30 mL/h and less likely among those with renal
clusions, 132 women were eligible for randomization: 60 failure, although these findings were not significant at
women were still pregnant, and 72 women were in the the multivariate analysis. Platelet counts did not reach
puerperal state. Two patients received only 2 doses of levels of O100,000/mm3 in all 4 maternal deaths.
steroid after delivery because of death. Two women (in LDH levels of !600 U/L were not reached before
the experimental and control groups) received 1 dose of discharge by 72 patients (38 experimental patients and
dexamethasone that was not provided by the study 34 control patients), which included the 4 deaths and 68
(Figure 1). patients who were discharged when their platelet counts
The mean age of enrolled women was 25.3 years were O100,000/mm3. There was no statistically signif-
(range, 14-44 years); the mean gestational age was 33.6 icant difference between treated and control patients
weeks (range, 20-41 weeks), and the mean parity was 2.4 who reached an LDH of !600 U/L before discharge
pregnancies (range, 0-12 pregnancies). Platelet counts regarding their time to recovery (Figure 2,C; Table III)
ranged from 13,000 to 100,000/mm3, with mean and or other patient characteristics at enrollment.
Fonseca et al
Figure 2 Cumulative risk of (A) discharge, (B) platelet recovery (count O100,000), (C) LDH recovery (!600 U/L), (D) AST
recovery (!70 U/L) according to treatment received.
AST levels of !70 U/L were not reached by 53
patients (32 experimental patients and 21 control pa-
tients), which included 2 of the maternal deaths and 51
patients who were discharged once their platelet counts
reached O100,000/mm3. Among patients with an AST
level of !70 U/L before discharge, there was a trend to
faster recovery among those patients who received
placebo (log rank test probability value, .07) that was
not significant after adjustment for renal failure, ethnic-
ity, and parity (hazard ratio, 0.7; 95% CI,0.4-1.1; Figure
2,D; Table III).
Recovery of clinical parameters
No significant differences in urinary output were found
between the 2 treatment groups. Furosemide was
required in 23 patients: 13 patients received placebo,
and 10 patients received dexamethasone therapy (rela-
tive risk, 0.8; 95% CI, 0.4-1.6). All patients were
hypertensive, and 124 patients (93.9%) required nifed-
ipine therapy; therefore, we were not able to evaluate
changes in blood pressure, because they could have
been associated with antihypertensive use. The addition
of a second antihypertensive drug was necessary in 30
patients, 13 of whom received dexamethasone therapy
1595
(P = .32). A third antihypertensive drug was required in
8 patients, 4 per treatment group.
Complications and blood transfusion
There were 4 maternal deaths, 3 deaths in the dexa-
methasone group and 1 death in the placebo group.
Three of the maternal deaths occurred in women with
liver failure and severe hemolysis, with AST and LDH
levels of O2600 U/L and O6450 U/L, respectively. The
other death was due to a cerebrovascular accident. The
treatment groups were not different regarding develop-
ment of complications or transfusion need (Table IV).
Interestingly, there were a higher number of infections
among those patients who received placebo, and mater-
nal death and pulmonary edema were more frequent
among those women who received dexamethasone ther-
apy, even after adjustment. Infections were found to be
associated independently with admission to the intensive
care unit (odds ratio, 10.4; 95% CI, 2.2-48.2), renal
failure (odds ratio, 8.8; 95% CI, 1.9-38.8), and vaginal
delivery (odds ratio, 6.7; 95% CI, 1.3-33.3). The higher
odds of infection with vaginal delivery remained after
adjustment for the occurrence of premature rupture of
membranes and the use of antibiotics and steroids
1596 Fonseca et al

Table III Determinants of duration of hospitalization, platelet count, LDH and AST recovery by univariate Cox regression
Duration of hospitalization Platelets* LDHy ASTz
x x x
Hazard ratio 95% CI Hazard ratio 95% CI Hazard ratio 95% CI Hazard ratiox 95% CI
Treatment
Placebok 1 1 1 1
Dexamethasone 1.3 0.87-1.94 1.2 0.80-1.77 0.9 0.53-1.52 0.6 0.39-1.05
Steroid use up to 2 weeks before delivery
Nok 1 1 1 1
Yes 0.9 0.60-1.46 0.9 0.59-1.43 1.0 0.58-1.88 1.2 0.73-2.12
Delivery
Vaginalk 1 1 1 1
Cesarean 0.8 0.51-1.27 0.7 0.47-1.09 1.2 0.68-2.17 1.4 0.8-2.33
Class HELLP at admisión
HELLP 1k 1 1 1 1
HELLP 2 0.8 0.54-1.28 1.2 0.79-1.81 1.3 0.76-2.32 0.9 0.56-1.5
Acute renal failure at admission
Nok 1 1 1 1
Yes 0.3 0.15-0.44 0.5 0.22-0.99 0.3 0.07-1.17 0.5 0.17-1.36
Urinary output at admisión
!30 cc/hourk 1 1 1 1
31-100 cc/hour 4.7 1.94-11.52 2.4 1.07-5.17 1.2 0.47-3.26 1.3 0.50-3.46
O100 cc/hour 5.8 2.13-15.80 2.6 1.07-6.22 0.8 0.23-2.45 1.9 0.64-5.46
* Platelets above 100,000/mm3.
y
LDH below 600 U/L.
z
AST below 70 U/L.
x
Non-adjusted Hazard ratio.
k
Reference category.

Table IV Complications associated with HELLP syndrome

according to steroids use
Placebo Dexamethasone R.R. crude
Complication n (%) n (%) (95% CI)
Acute renal 8 (12.9) 6 (10.0) 0.8 (0.29-2.10)
failure*
Oliguria 4 (6.06) 5 (7.58) 1.3 (0.35-4.45)
Pulmonary 1 (1.54) 3 (4.62) 3.1 (0.32-28.09)
edema*
Eclampsia 10 (15.15) 8 (13.79) 0.8 (0.34-1.90)
Infections 10 (15.15) 5 (7.58) 0.5 (0.18-1.38)
Dead 1 (1.52) 3 (4.62) 3.0 (0.32-28.1)
Platelets 10 (15.15) 12 (18.18) 1.2 (0.56-2.58) Figure 3 Interval between randomization and recovery of the
transfusión platelet count to O100,000/mm3 by study group among
Plasma 6 (9.09) 5 (7.58) 0.8 (0.27-2.60) patients with HELLP 1.
transfusión
* Only included patients without the event before randomization. tions, recovery of laboratory parameters, transfusion
need, or duration of hospitalization. Among puerperal
before randomization. Platelet transfusion was found to women, the mean duration of hospitalization tended to
be associated with the development of renal failure be lower in those women who received placebo than in
(odds ratio, 4.0; 95% CI, 1.1-14.3) and AST levels at those women who received dexamethasone therapy (6.8
enrollment. vs 8.2 days), but this difference was not significant.
Median duration was 4 days in both groups; the
Subgroup analysis by pregnant interquartile ranges were 3 to 9 days and 3 to 6 days,
and puerperal patients respectively. Among pregnant women, the duration of
hospitalization was lower in the women who received
Stratified analysis of pregnant and puerperal groups dexamethasone therapy (4.5 vs 9.9 days), but this
showed no differences in the occurrence of complica- difference did not reach statistical significance. The
Fonseca et al
Table V Randomized clinical trials of corticosteroids in HELLP syndrome
Author Year Number of subjects Antepartum
Magann 1994 25 Yes
Magann 1994 25 No
Vigil-De Gracia 1997 34 No
Yalcin 1998 30 No
Isler 2003 32 No
Present work 2005 132 Yes
median duration was 4 days in both groups, and the
interquartile ranges were 3 to 4.5 days and 3 to 7 days
for dexamethasone therapy and placebo, respectively.
Subgroup analysis by severity
The time to recovery of the platelet count was found to
be heterogeneous when the cases were stratified by
HELLP class at the time of enrollment (Mantel-Cox
test: chi-squared test, 4.76; P = .03). Therefore, we
performed a subgroup analysis according to severity at
enrollment. No differences were found among patients
who were classified as HELLP class 2 and control
subjects; however, among 49 patients with HELLP
1 (28 patients with placebo and 21 patients with dexa-
methasone therapy), the conditional probability of
platelet recovery was higher in those patients who
received dexamethasone therapy (Figure 3), even after
adjustment for potential confounders (hazard ratio, 3.4;
95% CI, 1.3-8.5). Also, the duration of hospitalization
was shorter among women who received dexamethasone
therapy when means (4.6 and 10.4 days), medians (3.5
and 5.0 days), and interquartile ranges were compared.
This trend persisted after adjustment (P = .03).
Comment
Several randomized clinical trials have been published to
evaluate the effect of dexamethasone therapy in women
with HELLP syndrome.9-11 Although they indicate that
dexamethasone therapy is beneficial, the strength of this
conclusion is limited because of small number of patients
in each trial, the lack of blinding and placebo controls,
the inclusion of women with mild forms of the disease,
and the lack of an strict definition of the syndrome (Table
V). Observational studies have also found better out-
comes in patients with HELLP syndrome who received
dexamethasone therapy. However, 2 of the studies were
retrospective, with historic control groups,17,18 and the
other 2 studies compared different steroids.19,20
To the best of our knowledge, this is the largest
reported clinical trial to evaluate the use of dexameth-
asone therapy in HELLP syndrome and the first that is
double blind and placebo controlled. This is also the first
1597
Postpartum Placebo controlled Double blind Benefical effect Ref
No No No Yes 8
Yes No No Yes 9
Yes No No Yes 10
Yes No No Yes 11
Yes No No Yes 19
Yes Yes Yes No
study among patients with HELLP syndrome that
report sample size estimation. The estimate was based
on the duration of hospitalization because it has been
widely accepted that this outcome variable reflects the
development of complications and the rate of recovery
of clinical and laboratory variables and because it is a
useful indicator for patients and clinicians. Other valu-
able features in this study that support its internal
validity are the study design (stratified randomization
in blocks and double blind) and the small number of
protocol violations that result in compliance with the
assigned treatment of O95%. The external validity of
this study is also high probably because of the large
number of eligible patients who accepted randomiza-
tion, the adoption of a widely accepted dose of dexa-
methasone for the treatment group, the use of
betamethasone in preterm deliveries, and the clinical
relevance of the outcome measures.
A weakness of this study is that 28.03% of our
patients received betamethasone during the 2 weeks
before delivery for the purpose of accelerating fetal lung
maturity and preventing neonatal intracranial bleeding.
However, analyses were carried out to adjust by previ-
ous steroid administration (Table III). Furthermore,
analyses were carried out that included only women who
did not received other steroids before delivery (45
women in the placebo group and 50 women in the
dexamethasone group; power, O90%; a, .05) with
similar results; therefore, previous administration of
betamethasone did not affect final results.
The results of this study indicate that the adminis-
tration of dexamethasone in patients with complete class
1 and 2 HELLP syndrome, when compared with similar
patients who received placebo, does not reduce the
number of complications or the need for blood products
administration or shorten platelets and LDH recovery.
These results were consistent in global and planned
subgroup analysis. Contrasted with previous studies,
AST recovery was slower in patients who were assigned
to dexamethasone therapy than to placebo, and this
finding remained in the subgroup analysis. Unfortu-
nately, we cannot speculate about the clinical implica-
tions of the last finding, given that patient follow-up
evaluations finished at the time of platelets recovery,
regardless of AST levels.
1598
Although no statistically significant differences were
found in the planned analysis of the duration of hospi-
talization, those pregnant women who received placebo
stayed, on average, twice as long as those women who
received dexamethasone therapy (9.9 vs 4.5 days). This
difference was due to 2 patients of the control group
who stayed long periods (49 and 89 days), one of whom
had rupture of the uterus and subsequent complications,
and the other who refused blood transfusion, regardless
of clinical indication (hemoglobin levels of 6.2 and 2.8 g/
dL before and after cesarean delivery), and experienced
respiratory distress syndrome and renal failure that
prolonged the hospitalization. These 2 outliers affected
the mean duration of hospitalization, but comparisons
of median and interquartile range did not show differ-
ences between groups.
Subgroup analysis according to the severity of disease
showed that, among patients with HELLP 1, there were
a shorter average time to platelet recovery and less
duration of hospitalization in women who received
dexamethasone therapy. The importance of this finding
is diminished because this was an unplanned analysis
and the severity of the disease was not taken into
account at randomization. It is accepted that the results
of an unplanned subgroup analysis should be considered
exploratory.21
In summary, the results of this investigation do not
support the use of dexamethasone for treatment of
HELLP syndrome. In women with class 1 HELLP,
further studies would be required to evaluate the
potential benefit of this intervention.
Acknowledgments
We thank the residents in Obstetrics and Gynecology at
the University Hospital, Universidad del Valle, Cali,
Colombia, for their help in this project.
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