REVIEW QUESTION

Is 12 hours administration duration of magnesium sulphate (MgSO4) as effective

as 24hours in preventing recurrence of seizure in postpartum women with
severe preeclampsia?

Preeclampsia is one of the global leading causes of maternal morbidity and mortality rate
(Eiland et al 2012). It affects at least 2 to 8% pregnancies worldwide (WHO, 2005). High
blood pressure, proteinuria and organ dysfunctions are cardinal signs (lambert et al 2014).
Warning signs are persistent headache, blurred vision, confusion, epigastric abdominal pain
(Steegers et al 2010). However, the predisposing factors are pre-existing maternal
hypertension, diabetes, obesity, advanced age, multiple gestations (twins or multiple births)
and autoimmune diseases (Arulkumaran et al 2013).

Eclampsia is a major complication of preeclampsia that could result to intrauterine growth

restriction (low-birth weight), placenta abruption, placental insufficiency, foetal distress or
preterm births (Bersten, 2014). Pritchard or Zuspan are the two regime of administration
used in practice for duration of 24 hours which is commenced either after last fit or after
delivery whichever comes first (Pritchard 1984 : Zuspan 1978).

World Health Organisation (WHO) recommends magnesium sulphate (MgSO4) as the most
effective drug of choice for treatment of preeclampsia and eclampsia (WHO, 1994). The
rationale for continuum of MgSO4 for 24hours post-delivery is that 25% of seizures happen
within 12 to 24 hours after delivery (Miles et al 1990). The safety in the use of MgSO4 has
been reported in Smith et al 2013 review. Some research works has been done on
administration duration but no review yet. This review examines the efficacy of 12hours
administration duration compared with 24hours at preventing recurrence of seizure in
postpartum women with severe preeclampsia.
Table 1: The review question and essential component

Sackett et al 2000 PICO (Patient, Intervention, comparison, outcome) structure was used
classify review question into essential components;

Is 12hours administration duration of Magnesium sulphate (MgSO4) as effective as

24hours in preventing recurrence of seizure in postpartum women with severe
preeclampsia?

PICO analysis showing main facet of review question

Patient Intervention Comparison Outcome

Postpartum women 12hours 24hours Seizure recurrence

with severe administration administration
preeclampsia duration of MgSO4 duration of MgSO4

Research studies with a randomized controlled trial (RCT) design are adequate in answering
the above question as RCT is designed to minimise the risk of confounding variables that
could influence the expected outcome and the method provides the most reliable evidence
of effectiveness of treatment with result most closely related to the true effect than other
research methods like cohort studies or case-control studies (Evans, 2003)

Method

This review adopted NICE guideline manual (2012a) methodology and a Griffiths (2002)
view on conducting a mini-review was included. Cochrane library database of systematic
reviews was first checked to establish if there had been similar review done to avoid
duplication and Cochrane controlled trial register was checked too for existence of
published randomized control trial that answers the review question. A formal literature
search was then done using two databases; MEDLINE 1946 to March week 2 2018) and
Maternity &Infant database (MIDIRS) 1971 to January 2018. MIDIRS has an all-inclusive
current midwifery practice and maternal and child health care research while MEDLINE has
a comprehensive coverage of all medical and drug-related focus research (Lefebvre & Clarke
2007). Facet analysis of “population”, “intervention” and “outcome” was done (Table 2).
The main term

Facet was searched as MeSH terms/main term which were all exploded to increase
sensitivity. The synonyms (alternative words) of each MeSH term were searched as free text
with truncations and wild card to obtain all possible word endings. The main terms and
synonyms of each component were combined using Boolean operator “OR” while the three
PICO component were combined using Boolean operator “AND”. Comparison component
was not included in the analysis because of its similarity with intervention.

Table 2: Facet analysis and use of Boolean operators (BO)

Patient Intervention Outcome

MeSH Preeclampsia Magnesium Seizure

sulfate
Term OR OR
OR

Free Preeclamp* AND Magnesium AND Convuls*

Sul?ate
text OR OR
OR
Eclamp* Spams
Epsom salts
OR
OR
Fits
Anticonvul*

(*) truncation

(?) wild card

Given to the large number of studies on MEDLINE and MIDIRS, inclusion and exclusion
criteria (Table 3) was used to obtain relevant papers that relates to review question.

Table 3: Inclusion and Exclusion criteria

Inclusion criteria Exclusion criteria

1. Randomized controlled trial studies 1. Studies comparing magnesium

that compares 12hours versus sulphate with other
24hours administration duration of anticonvulsants, antihypertensive
magnesium sulphate. drugs or placebo

2. Study participants must be 2. Studies that are case reports,

postpartum women with severe expert opinion and systematic
preeclampsia reviews

3. Seizure/convulsion recurrence
3. Studies not written in English
must be an outcome measured
language.

Results

The search in MEDLINE yielded 263 results and 301 in MIDIRS with one additional hand

search paper from Maia et al 2014. Five hundred (n=500) duplicates were excluded which

gave a total of 65 citations. Furthermore, by mere reading the tittle and abstract sixty

(n=60) studies based on expert opinions, case reports and systematic reviews comparing

MgSO4 with other anticonvulsants and antihypertensive were excluded as irrelevant studies
(see figure 1). However, five (n=5) studies full text were obtained due to uncertainty about

their eligibility to answer the review question. Three (n=3) studies were further excluded

(see Table 4 for reasons) and 2 studies were selected (see Table 5) for the mini review.

Figure 1: PRISMA flowchart of search result and selected studies

Medline (R) MIDIRS [searched Hand Search one (1) paper.

[searched on 10th on 10th March,
March, 2018]: 263 2018]: 301 papers (See text on how)
papers

65 papers after duplicates were removed

500 duplicates removed

65 papers s screened by titles

54 irrelevant papers removed
by reading the titles alone

11 papers screened by abstracts

6 papers excluded after reading

abstracts

5 papers screened by reading full texts

3 papers excluded after reading

full text (see table 4 for reasons)

2 papers selected for narrative review and synthesis

Adapted from Moher et al. 2009

Table 4: Characteristic of excluded papers

No Reference Reason for exclusion

1. Chama et al 2013 5mg MgSO4 4hourly for 24hours (standard maintenance

dose of Pritchard regime) was compared to 5mg MgSO4
4hourly for 8hours.

2. Darngawn et al 2012 Ringer lactate infusion and MgSO4 for 6hours was
compared to 24hours duration.

3. Shaheen et al 2015 Magnesium sulphate therapy comparing 12hours and

24hours duration for eclampsia not severe eclampsia

Description of included studies

Maia et al 2014 conducted an open-label, randomized clinical trial to compare the use of
magnesium sulphate for 12hours versus 24hours in postpartum women with severe
preeclampsia. 120 participants recruited were postpartum women with severe
preeclampsia and no underlying conditions like pre-existing diabetes mellitus, epilepsy or
renal diseases. The participants were randomized into two groups (12hours and 24hours)
with 60 participants in each group. The prescription was MgSO4 infusion at 1g/hour.

Kashanian et al 2015 conducted a randomized clinical trial comparing administration

duration of MgSO4 for 12hours versus 24hours after delivery in patient with severe
preeclampsia. 182 participants were recruited and randomized into two numerically even
case and control groups. The prescription was Pritchard regime for 12 hours and 24 hours
duration.
Table 6: Risk Of Bias Assessment (adapted from NICE 2012b)

Table 5. Characteristics of included studies; Efficacy of 12hours versus 24hours MgSO4 administration duration on
postpartum women with severe preeclampsia.

Study reference Maia et al 2014 Kashanian et al 2015

Tittle Abbreviated (12hour) versus A comparison between the two

traditional (24hour) postpartum methods 0f magnesium sulphate
Methodology magnesium sulphate in severe administration for duration of 12
preeclampsia. versus 24hours after delivery in
patients with severe preeclampsia

Study design Open-label randomized clinical Randomized clinical trial

trial

Method of allocation Randomization Randomization

Allocation concealment Group allocation concealed in Not mentioned

opaque ,sequentially numbered
envelops

Inclusion criteria Postpartum women with severe Not explicitly stated but inferred as in
preeclampsia definition of severe preeclampsia

Exclusion criteria Women with eclampsia with Not mentioned

evident haemolysis, low
platelet count,(HELLP)
Syndrome, pre-existing
diabetes etc.

Blinding of outcome Not applicable as it was an Not mentioned

assessment “open label” clinical trial

Power calculation Described Described

Study population Postpartum severe Postpartum severe preeclampsia

preeclampsia

Attrition Reported Reported

Exclusions (n=4) case group (n=12) case group

(n=4) control group (n=0) control group

Participants Total sample size 120 182

Groups similar at the Yes Yes

beginning
Participant Postpartum women
characteristics
In-patients
diagnosed with severe
preeclampsia with no existing
comorbidity,
Number of pregnancies=(1-3)
Gestational age=33 to 42
weeks,
route of delivery= Caesarean
section
Case group/ treatment Magnesium sulphate infusion at
group 1g/hour for 12hour (case
group) administration duration
and physicians were permitted
Intervention
to continue treatment for
24hours if seizure occurs within
or after 12hours.
Control group Magnesium sulphate at
1g/hour for 24hours (control
group) administration duration
and physicians were permitted
to extend treatment if seizure
occurs after 24hours.
Length of follow up 12 hours to 24 hours
Outcome measured Primary outcome
 The duration of
anticonvulsant therapy
postpartum. (outcome
of interest)
Secondary outcome
 Patient satisfaction at
24hours after delivery
 Clinical measures such
as blood pressure
 Time to return to
ambulation(hours)
 Duration of indwelling
urinary catheter use
Postpartum women
In-patients
diagnosed with severe preeclampsia,
Age=22 to 36 years.
Number of pregnancies=(1-4)
Gestational age=34 to 38 weeks
Route of delivery= Not mentioned
MgSO4 was administered 4g slowly (I
gram per minute infusion) plus 10g
intramuscularly (IM) i.e. 14g in total
and then 5g MgSO4 was prescribed
IM every 4hours for 12hours in case
group.
MgSO4 was administered 4g slowly (I
gram per minute infusion) plus 10g
intramuscularly (IM) i.e. 14g in total
and then 5g MgSO4 was prescribed
IM every 4hours for 24 hours in the
control group.
12 hours to 24hours
Primary outcome
 Convulsion (outcome of
interest)
Secondary outcome
Not stated
Critical Appraisal

As informed by Huwiler-Muntener et al 2012, reporting quality and risk of bias (Table 6)

was performed separately with CONSORT RCT checklist (Moher et al 2001) and NICE
methodology checklists(NICE 2012b) respectively.

Kashanian et al 2015 was clear about RCT study design used but omitted vital details about
the study conduct. No information was provided on sequence generation {Quote (from
report) “randomly assigned into the groups”}. Also, there was no information on allocation
concealment and blinding of participants, personnel and outcome assessors stated. This
suggests that selection bias and performance bias is very high in this study. Outcome data
of 12 participants from the case group were excluded with unclear reasons which brought
about imbalance in number outcome data in both groups. Attrition bias very high

In contrast, Maia et al 2014 studies were clear about the study design (open-label RCT);
they reported sequence generation {Quote (from report) “by random allocation software”}.
Allocation concealment was reported as concealed in opaque, sequentially numbered
envelopes. Selection bias in this study is very minimal. Given that an open-label RCT was
used, it explains why there was no report on blinding of participants, personnel and
outcome assessors and as such expects performance and detection bias to be very high.
They reported attrition and the number of participants excluded in both groups with
reasons for exclusion. Missing data however had no relevant impact on effect estimate
which makes attrition bias very minimal

Both studies also stated clearly which participants were included in the analysis and
reported the use of intention to treat analysis which makes potential bias very minimal.
Power and sample size calculation was adequately stated in both studies, which makes type
II / (β) error - failure to identify difference even if it existed (Simon, 2006) very minimal.

Table 6: Risk Of Bias Assessment (adapted from NICE 2012b)

Criteria for Reviewers’

judgement
Type of bias Authors Judgement Opinion

 Sequence Maia et al 2014 Yes Low risk of bias

generation
selection bias  Allocation Kashanian et al No High risk of bias
concealment
2015

Blinding of Personnel Maia et al 2014 No High risk of bias

or outcome assessors
Performance to treatment
allocation
Bias Kashanian et al No High risk of bias
2015

Were the reasons for Maia et al 2014 Yes Low risk of bias
exclusion addressed?
Attrition bias
Will missing data have
impact on
intervention effect Kashanian et al unclear
estimate?
2015 unclear risk of
bias

Detection bias Blinding assessor to Maia et al 2014 No

intervention and
High risk bias
confounding factors of
participants. Kashanian et al No
2015 High risk bias
Synthesis of results

Table 7: Outcome measure

Interpretations

12hours 24hours Mean difference P-Value (Statistically

Authors significant and
Parameter
(95% CI) Clinically
significant)

Maia et al Systolic blood Difference is

pressure statistically insignificant
2014 148.8 ±15.7 151.5 ± 16.4 2.7 (-3.3124-8.7124) 0.38 and clinically
insignificant.

Diastolic 98.6 ± 11.4 100.3 ± 10.4 1.7(-2.3865-5.7865) 0.40 Difference is

blood statistically insignificant
pressure and clinically
insignificant.

Systolic blood Difference is

pressure statistically insignificant
Kashanian 131.7 ± 12.3 132.8 ± 11.1 1.1(-2.4436-4.6436) 0.54 and clinically
et al 2015 insignificant.

Diastolic 1.5(-0.5122-3.5122) Difference is

blood statistically insignificant
pressure 83.7 ± 6.3 85.2±6.9 0.14 and clinically
insignificant.
Kashanian et al 2015 and Maia et al 2014 reported only P values of 12 versus 24 hours
systolic and diastolic blood pressure without stating their mean differences. MedCalc’s
software for comparison of means calculator was used to calculate the mean difference.
The reported means and their standard deviations with known sample size were imputed as
requested which gave the mean difference (95%CI) as needed (Table 7) to justify if the
mean difference in blood pressure were clinical significant or not. Both studies
demonstrated a statistically insignificant difference between 12 versus 24hours systolic and
diastolic pressure but the mean difference lead to the clinical judgement that the
differences are too small to be considered a big difference. For instance, the mean
difference between 148 ± 15.7 (12hours) and 151.5 ± 16.4 (24hour) of Maia et al’s report is
2.7 (small difference), however 2.7 is clinically not significant enough to say it’s crucial to
continue MgSO4 for 24hour knowing that the blood pressure outcome of both groups are
within the rate of blood pressure reduction <150mmHg which is a good clinical outcome.

Comparison of baseline blood pressure data versus after treatment (Table8) clearly shows
the effectiveness of MgSO4 in both groups. The difference is both statistically and clinically
significant. Being that the p value of 12 and 24hours blood pressure in both studies shows
same success rate, it is important to keep in mind drug toxicity in increased dosage,
economical benefit of effective less duration MgSO4 to developing countries with drug
scarcities and the adverse effects of medication (Gordon et al 2014).
Table 8: Comparison between baseline and after treatment blood pressure

Authors Test Blood Baseline After Difference in P value Comment

group pressure Treatment means (95%CL)

Maia et al 12hours systolic 142.1 ± 16.4 148.8 ± 15.7 6.4 (0.3876- 0.04 Statistically and clinically
2014 12.4124) significant
N=56
diastolic 92.4 ± 11.9 98.6 ± 11.4 6.2 (1.8359- 0.001 Statistically and clinically
10.5641) significant

24hours systolic 142.1 ±15.1 151.5±16.4 9.4 (3.4963- 0.002 Statistically and clinically
153037) significant
N=56
diastolic 95.4 ± 10.8 100.3 ± 10.4 4.9 (0.9294- 0.01 Statistically and clinically
8.8706) significant

Kashanian et 12hours systolic 152.2 ± 12.3 131.7 ±12.3 -20.500 <0.0001 Statistically and clinically
al 2015 ( -24.3658- significant
N=79 16.6342)

diastolic 95.2 ± 9.4 83.7 ± 6.3 -11.500 <0.0001 Statistically and clinically
(-14.0148- significant
8.9852)

24hours systolic 158.3 ± 15.4 132.8 ± 11.1 -25.500 <0.0001 Statistically and clinically
(-29.4267 to significant
N=91 -21.5733

diastolic 95.1 ± 9.5 85.2 ± 6.9 -9.900 <0.0001 Statistically and clinically
(-12.3287 to significant
-7.4713

Based on the desired outcome measured (Convulsion recurrence), Maia et al study

recorded 3 convulsion cases (approximately 95% no convulsion recurrence)in the 12hours
group and 100% success in 24hours group while Kashanian et al 2015 had 1 convulsion case
(99%) in 12hours group and again, 100% success in the 24 hours group. Basically, from a
clinical point of view, 95% and 99% success of a 12hour duration proof of effectiveness in
both studies should be considered as a very high above average success. With the incidence
of 3:1 convulsion reoccurrence in Maia et al 2014 and Kashanian et al 2015 studies
respectively, relative risk was calculated using MedCalc’s software calculator for relative risk
calculation (Table 9&10). The result shows that the p values for both studies are not
significant plus their confidence intervals included the number with no difference (1).
However, both relative risks are greater than one (1) which means the risk is increased.
Formula used for calculating increased relative risk is RRR(I)= [1-RR] X 100.

The calculation and interpretation of risk increased in Maia et al’s study (Table 9) is (1-7.0)
x100= 600% while in kashanian et al’s (Table 10) is (1-3.5)x100=250%. This means that, the
risk of convulsion recurrence in 12hours (exposed group) in Maia et al and Kashanian et al
studies was increased by 600% and 250% relative to the 24hours (unexposed group).
Alternatively, the convulsion recurrence was 7.0 and 3.5 times more likely to occur in the
12hours than in the 24 hours groups in Maia et al and Kashanian et al studies respectively.
Also, the number needed to treat (NNT) are 19% and 75% respectively in both studies which
implies that, for every nineteen (19) or seventy-five (75) post-partum women that had
12hour MgSO4 administration duration instead of 24hours in Maia et el and Kashanian et
al’s studies respectively, one (1) person case of convulsion recurrence will be
prevented/treated which would not have happened if all 19 /75 women got 24hour MgSO4
in their respective studies. This supports the common statement understood by health
professionals and patient which is; “20 patients need to be treated to avoid one additional
death for five (5) years” (Cook et al 1995).

Table 9: Relative Risk (RR) calculation

Maia et al 2014

Exposed group=56

Participants Control group=56

Exposed group Number with positive (bad) outcome =3

Number with negative (good) outcome =53

 Control group Number with positive (bad) outcome =0

Number with negative (good) outcome =56

Relative risk=7.0000
Results
95%CI= 0.3699 to 132.4651

z statistic= 1.299

significant level (p)=0.1946

NNT(Harm)= 19.00

95% CI =8.369 (Harm) to ∞ to 70.281 (Benefit)

Table 10: Relative Risk (RR) calculation

Kashanian et al 2015

Participants Exposed group=79

Control group=91

Exposed group Number with positive (bad) outcome =1

Number with negative (good) outcome =78

Control group Number with positive (bad) outcome =0

Number with negative (good) outcome =91

Relative risk = 3.4500

Results
95%CI= 0.1425 to 83.5116

z statistic= 0.762

significant level (p)=0.4462

NNT(Harm)= 75.102

95% CI =22.039 (Harm) to ∞ to 53.349 (Benefit)

Conclusion

The efficacy of 12hours versus 24hours MgSO4 at preventing convulsion recurrence in

postpartum severe eclampsia women gave a moderate quality when evaluated against the
GRADE system of rating quality of evidence (Balshem et al 2011). This rating was based on
risk of bias, inconsistency, imprecision, indirectness (Table 11)

Table 11: GRADE profile

Reference Design Risk of Inconsistency Imprecision Indirectness Other Quality

Bias consideration

21 RCT’s2 Seriousa No seriousb seriousc No seriousd None Moderate

inconsistency imprecision indirectness

Adopted from NICE (2012c)

1
Maia et al 2014, kashanian et al 2015
2
Open-label randomised clinical trial, Randomised clinical trial
a
Both studies had high risk of performance and detection bias. Maia et al 2014 has low selection, attrition and
reporting bias while kashanian et al 2015 omitted allocation concealment (selection bias) excluded 12 participants
that would have count for the outcome effect of the intervention group (Attrition bias).
b
Mean difference showed potential benefit in the both study and there was insignificant variability in result obtained
after treatment.
c
Confidence interval of both studies are wide and increases the range of possible population
d
Kashanian et al 2015 was direct in comparison and outcome. Maia differed a bit in outcome but still reported
outcome of effect needed.

The 12hours administration duration of MgSO4 from the two studies evaluated has no
difference statistically and clinically which means that clinically is quite safe to adopt the
12hours duration maintenance dose especially in developing countries. The benefits would
reduce pain form injection site, adverse effect and toxicity, drug cost and hospitalization
time, morbidly and mortality due to limited drugs and generally will save time for patient
and health professionals. Though the grade of evidence result is moderate (Table 11) a
strong recommendation to limit MgSO4 maintenance dose to 12hours can be made based
on the above benefits as it promotes cost effectiveness and patience cantered approach of
care delivery.

Further research with large sample size and improved selection and performance bias risks
is recommended to intensify the efficacy of 12hours reduced maintenance thereby
improving the quality.

This review was limited by the reviewer’s personal judgement, time constraint and the limit
required paper to be reviewed.
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Smith JM; Lowe RF; Fullerton

J; Currie SM; Harris L; Felker-

Kantor E.

Authors Full Name: Smith, Jeffrey Michael; Lowe, Richard F; Fullerton, Judith; Currie, Sheena M; Harris, Laura; Felker-Kanto

Institution: Smith, Jeffrey Michael. Jhpiego, 1776 Massachusetts Ave, Washington, DC 20036, USA. jsmith@jhpiego

Title: An integrative review of the side effects related to the use of magnesium sulfate for pre-eclamps

Source: BMC Pregnancy & Childbirth. 13:34, 2013 Feb 05.

Abbreviated Source: BMC Pregnancy Childbirth. 13:34, 2013 Feb 05.

NLM Journal Name: BMC pregnancy and childbirth

Publishing Model: Journal available in:

Citation processed from: Internet

NLM Journal Code: 100967799

ISO Journal Abbreviation: BMC Pregnancy Childbirth