17 Jun HOW DOES THE RESEARCH QUESTIONS/HYPOTHESES ADDRESS THE PROBLEM AS DETAILED BY THE RESEARCHER?
Using the article/research/study that you selected for your Unit 8 Discussion Board, address the following questions:•What is the intended purpose of the study? •How does the research questions/hypotheses address the problem as detailed by the researcher? •How does the content in the purpose statement and research questions define the methodology used in the study? •How was the data collected and analyzed? •What was the benefit of using the selected statistical test? •What was the outcome of the study?
Requirements
•Using one (1) of the methods below, develop a final project addressing the Assignment questions:•3–5 page executive summary •Power Point presentation (15–20 slides) •Infographic •Educational/training packet or guide
ORIGINAL ARTICLE
Oral nifedipine versus intravenous labetalol in hypertensive
urgencies and emergencies of pregnancy: a randomized
clinical trial
B Sathya Lakshmi MS DNB and Papa Dasari MD FICOG
Department of Obstetrics and Gynaecology, JIPMER, Puducherry, India
Summary
Background: Hypertensive crisis is an important cause of maternal and perinatal morbidity and mortality.
Aim: To compare the efficacy of oral nifedipine and intravenous labetalol.
Materials and methods: One hundred women with hypertensive crisis were randomized to receive either oral nifedipine 10 mg or
intravenous labetalol 20 mg. Oral nifedipine was given 10 mg stat followed by 10 mg every 30 minutes up to a maximum of 50 mg.
Intravenous labetalol was given 20 mg stat followed by 40 mg 30 minutes later then two more doses of 80 mg every 30 minutes up to a
maximum of 220 mg. The primary outcome was the number of doses required to achieve target blood pressure (BP) and time required
to reduce the mean arterial pressure by 25%. Secondary outcomes analysed included additional drugs required, resurgence of
hypertensive crisis. Data were analysed using repeated measures analysis of variance (ANOVA), mixed ANOVA, unpaired t-test and chi
square test and P value 0.05 was considered significant.
Results: Systolic (SBP), diastolic (DBP) and mean arterial blood pressure (MAP) were lower than baseline at all time points of followup
in both nifedipine and labetalol groups (P, 0.01). P, 0.05 by repeated measures ANOVA for overall trend of changes in SBP,
DBP and MAP for within-group effects in both nifedipine and labetalol groups and P, 0.05 by mixed ANOVA for between-group
effects during entire observation period. The magnitude of fall in SBP, DBP and MAP was greater in the labetalol group compared
with the nifedipine group (P, 0.05). Target BP was achieved in 90% in the nifedipine group and 92% in the labetalol group. Maternal
and fetal adverse effects were infrequent.
Conclusion: Both oral nifedipine and intravenous labetalol are effective in the treatment of hypertensive crisis. Intravenous labetalol
may have benefits because it is more effective in reducing the SBP, DBP and MAP to target levels with a lower number of doses.
Keywords: hypertension, complications
INTRODUCTION
Hypertensive disorders are the most common medical disorders
encountered during pregnancy and are responsible for
31% of the maternal deaths in India.1 The main causes of
mortality are severe pre-eclampsia, hypertensive crisis, cerebrovascular
accidents and HELLP (Haemolysis, Elevated Liver
enzymes, Low Platelet count) syndrome. A retrospective analysis
of maternal deaths due to hypertensive disorders at our own
institute revealed hypertensive crisis as the main cause of mortality.
2 There is still controversy regarding the initiation of antihypertensive
therapy in mild and moderate hypertension as
well as about the choice of antihypertensive therapy in hypertensive
emergencies and urgencies. According to the American
College of Obstetricians and Gynecologists (ACOG) committee
opinion (2011), acute onset, severe systolic (160 mmHg) or
diastolic hypertension (110 mmHg) or both in pregnant or
postpartum patients constitutes hypertensive emergency.3
National Institute for Health and Clinical Excellence guidelines
from 2010 recommend the use of intravenous hydralazine, oral
nifedipine and intravenous labetalol for the treatment of severe
hypertension in pregnancy which is defined as a systolic blood
pressure (SBP) 160 mmHg and/or a diastolic blood pressure
(DBP) 110 mmHg.4
Intravenous hydralazine has been the drug of choice since the
1970s but a recent meta-analysis cautions against its use as the
drug of first choice due to severe hypotension and other
maternal and fetal complications.5 Similarly, the use of sublingual
nifedipine and oral nifedipine has been criticized
because of an unpredictable decrease in blood pressure (BP)
and major cardiac events leading to maternal death and fetal
distress. A recent review advised against their use for hypertensive
crisis, although a randomized double blind trial of oral
nifedipine and intravenous labetalol did not report any
adverse outcome with oral nifedipine.6 In this context more randomized
trials are required.
This study was undertaken to compare oral nifedipine with
intravenous labetalol in hypertensive emergencies and urgencies
of pregnancy.
Correspondence to: B Sathya Lakshmi
Email: sbsatthya@yahoo.com
DOI: 10.1258/om.2012.120010. Obstetric Medicine 2012; 5: 171–175
MATERIALS AND METHODS
This randomized trial was undertaken in the Department of
Obstetrics, JIPMER, a tertiary care hospital in South India,
between September 2008 and April 2010. The study was
approved by Institute ethics committee (SEC/40/2008) and
informed consent was obtained from the patients or their relatives
in unconscious patients. Pregnant women of more than
28 weeks gestation or less than 48 hours postpartum with BP
of 160/110 mmHg or SBP 160 mmHg irrespective of DBP or
DBP 110 mmHg irrespective of SBP were included in the
study. Patients without end organ damage were categorized
as hypertensive urgency and those with end organ damage
like eclampsia, HELLP syndrome, hypertensive encephalopathy,
retinopathy and disseminated intravascular coagulation
were labelled as hypertensive emergency. Patients with
bronchial asthma, congestive heart failure and known atrioventricular
block were excluded.
The sample size was calculated using OpenEpi, version 2.3.1
software based on a similar study by Vermillion et al.6 With the
aim of detecting 20% difference in the time interval required to
reach the target blood pressure, and with 95% confidence interval
and power as 95%, it was calculated that 32 patients would
be required in each group. Patients fulfilling the selection criteria
were examined by one of the authors and a detailed
history regarding antenatal care, past medical, surgical, family
and obstetric history was taken. A general, physical and systemic
examination was done. BP was re-checked after one
hour of admission and a diagnosis of hypertensive urgency
or emergency was made. The participants were then randomized
by a computer-generated random number table into two
groups. The study was not masked. Group A patients received
tablet oral nifedipine 10 mg stat followed by 10 mg every 30
minutes till the target BP was achieved and or up to a
maximum of 50 mg. It is recommended that while administering
antihypertensive therapy, the mean arterial pressure should
not be reduced beyond 25% and therefore the target BP to be
achieved was calculated as a 25% reduction of mean arterial
BP compared with the admission BP.7,8 Once the target BP
was achieved, patients received a maintenance dose of nifedipine
10 mg eight hourly. Group B patients received intravenous
labetalol 20 mg stat followed by 40 mg 30 minutes later
and two more doses of 80 mg every 30 minutes until the
target BP was achieved and/or up to a maximum of 220 mg.
The dosing regimens were in accordance with those of ACOG
recommendations9 except that labetalol was given every 30
minutes in order to compare the time taken to achieve the
target BP with that of nifedipine. Once the BP was controlled,
patients received a maintenance dose of oral labetalol 100 mg
twelve hourly.8 BP was measured with non-invasive BP cuff
and all patients were on continuous monitoring. If the target
BP was not achieved with the maximum dose of antihypertensive,
nitroglycerin patch was applied. Resurgence of
hypertensive crisis was noted and treated with the same
drug. All patients with imminent eclampsia (symptoms of
headache, vomiting, epigastric pain and hyper-reflexia)
received a prophylactic dose of magnesium sulphate and
those with eclampsia received therapeutic doses of magnesium
sulphate. Investigations included urine protein, complete haemogram,
renal and liver function tests, ultrasonogram for
fetal growth and liquor and fundoscopy. Cerebral computed
tomography/magnetic resonance imaging was done if the
patients were comatose or having recurrent convulsions.
Maternal monitoring included a record of pulse rate, respiratory
rate, BP and urine output every 30 minutes until the target
BP was reached and thereafter for 24 hours. Success was
defined as a decrease in MAP by 25%. Uncontrolled hypertension
was defined as failure to achieve target BP after the
maximum dose. If there was no resurgence, BP was recorded
every eight hours until discharge. Patients were followed up
for 48 hours postpartum or until discharge. Fetal monitoring
was done by intermittent auscultation every 30 minutes in the
first stage of labour and every 5–10 minutes during the
second stage of labour. Cardiotocography was used once fetal
distress was suspected by intermittent auscultation.
The primary outcome was the number of doses required to
achieve target BP and the time required to reduce the MAP
by 25%. Secondary outcomes analysed included additional
drugs required, resurgence of hypertensive crisis, maternal
and fetal side-effects such as hypotension, maternal tachycardia,
headache, flushing, nausea and vomiting, dizziness, fetal
bradycardia abruption or cardiovascular accidents after starting
the antihypertensive medication. The overall trend of differences
in systolic, diastolic and mean arterial blood pressures
across the entire follow-up period were analysed using a
general linear model for within-group effects with repeatedmeasures
analysis of variance (ANOVA), and for betweengroup
effects with a mixed ANOVA. Significant differences
were further evaluated with Bonferroni post hoc analyses. A
two-tailed P value ,0.05 was considered statistically significant.
The other data were analysed using unpaired t-test,
Fischer’s exact test and chi square test and P value 0.05 was
considered significant.
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