The efficacy of 10gram intramuscular loading dose of

MgSO4 in severe preeclampsia/ eclampsia at a tertiary

referral centre in Northwest Nigeria

Okusanya B. O., Garba K. K. D., Ibrahim H. M.

Department of Obstetrics and Gynaecology, Federal Medical Centre Katsina

Correspondence to:
B. O. Okusanya
Email: babakusanya@yahoo.co.uk

Summary
Aims and Objectives: The efficacy of 10g intramuscular loading dose of magnesium
sulphate in women with severe preeclampsia/eclampsia was assessed at a tertiary
health centre for potential use at primary health level.
Subjects and Methods: Intramuscular 10g loading dose and 14g loading dose of
Pritchard were compared in women with severe preeclampsia/eclampsia. Primary
outcome measures were the occurrence of fits in women with severe preeclampsia,
further fits in those with eclampsia and maternal death. Other outcome measures
were mode of delivery and severe birth asphyxia at 5 minutes of life.
Results: One hundred and three women were enrolled; 54 and 49 women had 10g
and 14g loading dose respectively. No significant convulsions (p= 0.1424)
occurred in women with severe preeclampsia who had 10g intramuscular loading
dose and repeat convulsion was averted in 93% of women with eclampsia. 10g
loading dose did not increase the likelihood of caesarean section in women with
preeclampsia (p=0.2832) or eclampsia (p=0.9112). The mean Apgar score at 5
minutes of life of neonates whose mothers had 10g and 14g loading dose for
preeclampsia was 8 and 8.46 respectively, and 8.9 and 8.8 respectively for
eclampsia. There was no statistically significant difference in maternal death
between the two groups for severe preeclampsia (p= 0.2020) and eclampsia
(p=0.3496).
Conclusion: This study suggests a potential use of intramuscular 10 gram loading
dose of MgSO4 at the primary health care level in Nigeria.

Key words: MgSO4, eclampsia, maternal mortality, primary health care

Nigeria is a major contributor to the global burden
of maternal mortality1and the direct causes of maternal
deaths still remain haemorrhage, preeclampsia/eclampsia,
obstructed labour, sepsis and abortion-related deaths2,3.
When these complications of pregnancy arise, prompt and
adequate treatment is essential to the survival of the women
hence the concept of emergency obstetric care (EOC) to
avoid delays which have been identified as an important
factor in maternal death4,5 .
In many audits of maternal deaths in Nigeria, severe
preeclampsia/ eclampsia has been reported to be the main
direct cause of maternal deaths3,5,6. More so, the nationwide
needs assessment on the status of emergency obstetric
services in the country by the Society of Gynaecology
and Obstetrics of Nigeria (SOGON) reported eclampsia as
the main cause of maternal deaths in four states and the
second common cause in the two other states surveyed 4.
Though this was a facility-based survey, the geographical
spread of the facilities gave an insight to the contribution
this menace has to maternal deaths in Nigeria, yet, most
deliveries occur outside health facilities.
The 2008 National Demographic and Health survey
(NDHS) showed that 35% of women surveyed delivered
in a health facility and this was much lower among rural
dwelling women who had a facility delivery rate of 24% 7.
By implication, when women who deliver outside the health
facility develop eclampsia, they would be rushed to the
nearest health facility, usually a primary health facility, be

The Nigerian Postgraduate Medical Journal, Vol. 19, No. 3, September, 2012 143
The efficacy of 10gram intramuscular loading dose of MgSO4 : B. O. Okusanya et al
it public or private, where the evidence- based treatment,
mgso4, is not readily available at the moment. They
therefore present as unbooked parturient at the labour
wards of tertiary health facilities where they contribute
significantly to the maternal mortality ratio 2,3,5,8,9.
The use of MgSO4 in Nigeria started with the
Magpie Trial. The trial used the Pritchard regimen (I.V 4g
over 5-10min + 10g I.M loading dose and a maintenance
dose of 5g I.M 4 hourly for 24 hours after the last
convulsion or delivery depending on which occurs later).
Its use has been associated with statistical and clinical
reductions in recurrence of convulsions and maternal death
in women with eclampsia 6,11. Thereafter the efficacy of
mgso4 in the prevention of convulsions in women with
severe preeclampsia was reported 12, and some researchers
have gone further to modify the regimen without any
untoward foeto-maternal outcome 13.
The use of MgSO4 has been restricted to secondary
and tertiary health facilities in Nigeria and many of these
facilities, occasionally, do not have the drug in stock,
hence, the lack of MgSO4 prominence on the labour ward
emergency drug tray 14. At the present time, great hesitation
exists on the use of MgSO4 at the primary health care level
in Nigeria. This is because the two popular regimens,
Pritchard and Zuspan, have intravenous route of
administration of their loading dose and the initially
thought narrow safety margin. It has however been
reported that mgso4 toxicity is not as common and that
clinical monitoring of women is sufficient 15. Therefore,
the only limitation to introducing this evidenced-based
treatment to the primary health care level is the route of
administration of the loading dose.
We evaluated the use of 10gram intramuscular
loading dose of mgso4 in women with severe preeclampsia/
eclampsia at the labour ward of Federal Medical Centre
Katsina. This was aimed at assessing the prospects of
using intramuscular loading dose of mgso4 at the primary
health care level where women with these conditions are
likely to present first. It is hoped that this report would
engender its phased introduction in the treatment of
women at this level of health care as “first aid”.
Subjects and methods
This was a descriptive comparative study at the
labour ward of Federal Medical Centre Katsina, Northwest
Nigeria. It is a tertiary referral centre with an annual delivery
rate of about 3000. Many of the women cared for at the
labour ward present after the onset of complications in
pregnancy. Women were enrolled if they had either severe
preeclampsia or eclampsia at the antenatal and labour
wards. Severe preeclampsia was defined as blood pressure
e” 160/110 mmHg and proteinuria of at least 2 pluses (++)
using bed side urinalysis test strips (dipsticks). In addition
to this, eclampsia was defined by occurrence of
convulsions in a pregnant woman when she meets the
definition of severe preeclampsia.
144 The Nigerian Postgraduate Medical Journal, Vol. 19, No. 3, September, 2012
Women were also enrolled if either the systolic or
the diastolic blood pressure met the stated cut-offs in the
presence of significant proteinuria; at least 30mg/dl.
Hypertension was managed with intravenous Hydralazine
if diastolic blood pressure was e”110 mmHg and
subsequently by oral methyl dopa and nifedipne, only if
they were fit enough for oral intake.
Excluded from the study were women who had
diazepam prior to arrival and those with history of chronic
seizure disorder. A group had intramuscular 10 g loading
dose of MgSO4 and maintenance dose was 5g I.M 4 hourly
till 24 hours after delivery or the last convulsion depending
on which occurred later. Women with severe preeclampsia
had maintenance dose till 24 hours after delivery. The other
group had the Pritchard regimen as stated earlier.
The respiratory rates, knee jerk reflex and hourly
urinary output estimation were used to monitor signs of
MgSO4 toxicity in both groups. MgSO4 toxicity was ruled
out if the women had respiration e”15 cycles/min; urine
output e” 25ml/hour and no loss of knee jerk reflex. 10ml of
10% calcium gluconate was made available should any
woman develop MgSO4 toxicity. Though the side effects
of mgso4 were not outcome measures because they occur
uncommonly 15, they were noted.
The enrolment of women was prospective between
1 April 2008 and 25 October 2009. Women enrolled between
1 April 2008 and 30 April 2009 had 10g loading dose of
mgso4 while 14g loading dose was used from 1May 2009
to 25 October 2009.
Outcome measures used in this study were as follow;
Primary outcome measures
- Occurrence of convulsion in women with severe
preeclampsia
- Recurrence of convulsion in those with eclampsia
- Maternal death
Secondary outcome measures
- Route of delivery
- Apgar scores less than 7 at 5 minutes of life.
The sample size for the study was calculated from a
formula for comparative study 16 using a prevalence of 1%
8
for eclampsia and the occurrence of further fits (7%) after
the use of 14g loading dose of MgSO4 in a Nigerian
population13. The average of the calculated sample sizes
from the two studies was used as the sample size for this
study. By this, 17 women were required in each arm of the
study. We, however, had a target of 45 women for each
arm of the study for it to give a better representation.
A comparative analysis was made between the two
groups. Analysis for statistical significance was done
using Yate corrected Chi square at 95% confidence interval.
It was significant if p was <0.05. When the figure in a cell
was less than 5, 1-tailed Fisher exact test was used. Ethical
approval for this study was given by the hospital’s Ethics
committee. Verbal consent was obtained from women who
were enrolled in the study. Those who had severe
preeclampsia were counselled and gave their consent.
The efficacy of 10gram intramuscular loading dose of MgSO4 : B. O. Okusanya et al

Consent was given by the relatives of the women who developed eclampsia. They were in the 14g loading dose
had eclampsia if they were not in a state to give consent. group.
As in table ii, sixty eight percent (17/25) and 50%
Results (15/30) of women in the 10g and 14g loading dose groups
One hundred and three women were enrolled into respectively had vaginal delivery with no statistical
the study. Fifty four (54) women had 10g loading dose significant difference in the route of delivery in the two
while 49 women had the Pritchard regimen. The socio- groups (p = 0.2832). The mean Apgar score at 5 minutes of
demographic characteristics of women in both groups were life was 8 ± 2.8 and 8.5 ± 2.9 for the 10g and 14g group
similar as they were mainly unbooked, nullipara, respectively. Also, there was no significant difference in
housewives and Hausa women as shown in table i. The neonatal Apgar score less than 7 at 5 minutes of life between
mean age of the 10g and 14g groups was 24.9 ±5 years and the two groups (P = 0.2373), although six intrauterine foetal
25.1 ± 5 years respectively. demise occurred in women who had 10g loading dose of
Fifty five (55) women had severe preeclampsia in mgso 4. Women with severe preeclampsia who had
this study; 25 women had 10g loading dose while 30 women intramuscular 10g loading dose did not develop eclampsia,
had 14g loading dose. 53% (29/55) were booked while 47% though this was not significant (p= 0.1424).
(26/55) were unbooked women. The mean systolic and Forty eight (48) women were managed for eclampsia
diastolic blood pressure of the 10g group were 173 ± 13 in this study; 29 had 10g loading dose and 19 had 14g
mmHg and 114 ±11 mmHg respectively while those of the loading dose. Unlike women with severe preeclampsia,
14g group were 173 ± 13mmHg and 111 ±11mmHg those admitted for eclampsia were mostly unbooked
respectively, and most of them (26/55) had 3+ proteinuria. (85.4%). The mean systolic and diastolic blood pressure
Three out of 29 booked women (10.3%) subsequently of the 10g group were173 ± 13 mmHg and 114 ±11 mmHg
respectively while those of the 14g group were 173 ±
13mmHg and 111 ±11mmHg respectively, and most (19/48;
Table i: Socio-demographic characteristics of sample 40%) of them had 3+ proteinuria.
population Eclampsia occurred antepartum, intrapartum and
Characteristics 10g loading Pritchard postpartum in 75.9% (22/29), 17.2% (5/29) and 6.9% (2/29)
dose regimen respectively in women who had 10g loading dose while in
n (%) n (%) those who had 14g loading dose, eclampsia occurred
Booking Status antepartum, intrapartum and postpartum in 57.9% (11/19),
Booked 20 (37) 16 (32.7) 15.8% (3/19) and 26.3% (5/19) respectively.
Unbooked 34 (63) 33 (67.3) As in table iii, two (7%) of women who had 10g
Parity
intramuscular loading dose had recurrent convulsion while
0 26 (48.2) 16 (32.7)
1 8 (14.8) 9 (18.4)
no repeat convulsions occurred in those with 14g loading
2 4 (7.4) 4 (8.1) dose. Occurrence of repeat convulsions was not
3 1 (1.9) 2 (4.1) significant in women who had 10g intramuscular loading
4 3 (5.6) 4 (8.1) dose of MgSO4 (p= 0.1948). Fifty five per cent (16/29) and
>5 12 (22.2) 14 (28.6)
Age (yr) Table ii: Outcome between the two groups in severe pre-
15-19 10 (18.5) 12 (24.5) eclamptics
20-24 22 (40.7) 9 (18.4)
Outcome 10g loading 14g loading P value
25-29 6 (11.1) 15 (27.8)
dose dose
30-34 10 (18.5) 7 (13.0)
n=25 n=30
35-39 3 (5.6) 4 (8.2)
>40 3 (5.6) 2 (4.1) Vaginal delivery 17 15 0.2832
Occupation Onset of convulsion 5 2 0.1424
Housewife 45 (83.3) 45 (91.8) Maternal death 2 0 0.2020
Civil servant 3 (5.6) 3 (6.1) Neonatal Apgar score 5 4 0.2373
Hairdressing 1 (1.9) 1(2.1) (< 7 at 5minutes)
Trading 1 (1.9) -
Student 1 (1.9) - Table iii: Outcome between the two groups in eclamptics
Ethnicity
Hausa 45 (83.3) 44 (89.8) Outcome 10g loading 14g loading P value
Igbo 5 (9.3) 1 (2.0) dose dose
Edo 1 (1.9) 1 (2.0) n=29 n=19
Yoruba - 3 (6.1) Vaginal delivery 16 9 0.9112
Others 2 (3.7) - Recurrent convulsion 2 0 0.1948
Religion Maternal death 2 0 0.3496
Islam 45 (83.3) 45 (91.8) Neonatal Apgar score
Christianity 9 (16.7) 4 (8.2) (< 7 at 5 minutes) 5 8 0.9396

The Nigerian Postgraduate Medical Journal, Vol. 19, No. 3, September, 2012 145
The efficacy of 10gram intramuscular loading dose of MgSO4 : B. O. Okusanya et al

47.4% (9/19) of the women with eclampsia had vaginal Our study reiterates the benefit of good antenatal
delivery in the 10g and 14g loading dose group care as the majority of booked patients who developed
respectively (p = 0.9112). The mean Apgar scores at 5 severe preeclampsia (89.7%), had hypertension and
minutes of life were 8.6 ± 2.9 and 8.9 ± 3 for the 10g and 14g proteinuria detected and eclampsia prevented. Routine
loading dose respectively for eclampsia and there was no urinalysis and blood pressure check at every antenatal
statistically significant difference in the neonatal Apgar clinic attendance should be emphasised. This is especially
score less than 7 at 5 minutes between the two groups so as the mean systolic and diastolic blood pressure and
(p=0.9396). the magnitude of proteinuria in women with severe
The case fatality for eclampsia in the study was preeclampsia were similar to those who had eclampsia.
4.2%. Most of the complications were observed among Basic emergency obstetric care (BEOC) refers to a
women who had 10g loading dose of mgso4. Two maternal package of clinical “signal functions” needed to prevent
deaths each occurred among women with preeclampsia deaths from the main direct obstetric complications18.
and eclampsia who had 10g loading dose. No maternal These signal functions are parenteral antibiotics, parenteral
deaths occurred in women who had Pritchard regimen. oxytoxics, parenteral anticonvulsants, manual removal of
While 6 perinatal deaths were recorded in eclamptic the placenta, assisted vaginal delivery (usually ventouse)
women who had 10g loading dose of MgSO4, none was and removal of retained products of conception (often by
recorded among eclamptics who had 14g loading dose. manual vacuum aspiration). Facilities offering BEOC
The perinatal mortality ratio for eclamptic women who had services should have performed these six signal functions
10g loading dose of MgSO4 was 241 per 1000 live births. within the previous three (3) months preferably, 24 hours
In the severe pre-eclamptics, there were 19 live births and every day of the week, before it can be said that services
6 perinatal deaths in those who had 10g loading dose are available18.
mgso4 (perinatal mortality ratio, 240 per 1000). In the severe Unfortunately, most of our primary health centres,
pre-eclamptic group that had 14g loading dose mgso4, if not all, do not render one function or the other and
there were 26 live births and 1 perinatal death (perinatal definitely not the use of mgso4. Although this study did
mortality ratio, 35 per 1000). not focus on the sources of referral of women who had
eclampsia, unbooked patients constituted the majority of
women in the study which compares with previous reports
8,9
. They, therefore, did not have an opportunity to have
Secondary
Primary
Health
access to MgSO 4 until they arrived at our facility
facility facility
Health demonstrating a very high unmet need for mgso4 at the
community level. To reduce the proportion of unmet need
History & Give I.V. 2g MgSO4
for MgSO4, therefore, it has to be introduced at the primary
Examination slowly over 5-10min
then 1.M 5g maintenance
health care facilities, especially, as it has been reported
dose 4 hrly that of all the Millennium Development Goals (MDGs),
(i.e. Continue Pritchard)
goal 5 is the furthest behind target19.
Unlike eclampsia, diagnosis of severe preeclampsia
I. M
10g MgSO4 If convulsion may be a challenge at the primary health care level. In this
loading dose recurs study we used the dipstick to detect proteinuria because
that is what is available at that level of care. Though several
studies have reported that it did not correlate well with the
Referral disease condition due to low sensitivity and specificity
Observe for 19,20
30 min If no recurrent
, a suggestion of 12 hour urine collection for the
arrange for
transportation
Convulsion estimation of proteinuria as a compromise for the 24 hour
urine collection has been made20. Clinicians would agree
Give 5g I.M maintenance that either 12 or 24 hour urinary protein estimation cannot
dose
(i.e. Continue Pritchard) be done at primary health facilities. More so, once a woman
develops either severe preeclampsia or eclampsia, she
Figure 1: Flow chat for using MgSO4 at primary health should be stabilized and delivered by the most expeditious
facility. route thereby negating the need for these time- consuming
but reliable investigations in women with an indication for
Discussion MgSO4 administration.
Improving women’s health in poorer countries, like Ten (10) gram intramuscular loading dose of MgSO4
Nigeria, requires more funding, more health workers and prevented eclampsia in most (80%) women who had severe
better application of what we know works17. In the context preeclampsia and recurrent convulsion in 93% of those
of eclampsia, it implies better and universal use of MgSO4 with eclampsia in this study. The recurrent convulsion
in the treatment of women with severe preeclampsia/ rate of 7% was as reported in a study which used only the
eclampsia because of its contribution to maternal mortality. 14g loading dose of MgSO4 in a Nigerian population13.

146 The Nigerian Postgraduate Medical Journal, Vol. 19, No. 3, September, 2012
The efficacy of 10gram intramuscular loading dose of MgSO4 : B. O. Okusanya et al
More so, the administration of 10g loading dose of
MgSO4 did not increase the chances of caesarean section
or severe birth asphyxia at 5 minutes of life. The perinatal
mortality ratio of the group, though bad, may be accounted
for by the study design in which 10g loading dose was
used for a period before it was switched to the Pritchard
regimen. To buttress this, six women with eclampsia were
admitted with intrauterine foetal demise prior to
administration of 10g loading dose.
Despite this outcome, the best role primary health
facilities could play in the management of these conditions
is accurate diagnosis, giving of “first aid intramuscular
MgSO4” and prompt referral. Although this study was at a
tertiary health facility, implementing this recommendation
at primary health facilities after appropriate training is not
only feasible but also achievable. The reason for these
responsibilities is because of the attendant complications
which may arise in women with severe preeclampsia/
eclampsia. These complications cannot be adequately
managed at the primary health facilities thereby leading to
neonatal death, maternal death or both.
In our study four women who had the 10g loading
dose died. No post mortem examination was done on any
of them. These deaths may have no direct link to the 10g
intramuscular loading dose but the study design. This
observational study has laid the basis for a randomised
controlled trial which would give a better insight. These
deaths could also have been prevented if the women had
access to MgSO4 and other effective care earlier. All
women in this study had the same dose and route of
administration of the maintenance doses, the difference
being in the loading doses. It therefore suggests that in
most women, 10g intramuscular loading dose of MgSO4
could prevent first fit in severe preeclampsia and recurrent
fits in eclampsia. More so, the event rates (recurrent
convulsion, maternal death, perinatal death) reported in
this study demonstrates the prospects of the use of 10g
intramuscular loading dose of MgSO4 at primary health
facilities but further studies are required. This is more
particularly so since the reported complications in each
group of the study may be accounted for by the study
methods as earlier stated. Perhaps, it may have been better
if intrauterine fetal death at presentation was an exclusion
criterion of the study.
The authors recommend that women with severe
preeclampsia/eclampsia at the primary health facility should
be examined and a diagnosis made. They should have
intramuscular 10g loading dose of MgSO4 and arrangement
for transport made to a nearby secondary health facility
within half an hour (30 Minutes). If no convulsions
recurred while in transit, on arrival at the secondary facility,
she is maintained on 5g 4 hourly intramuscular doses of
MgSO4 and Pritchard regimen is continued. However, if
she had a repeat convulsion in transit, she should be given
2g intravenous mgso4 on arrival at the secondary health
facility and Pritchard regimen continued. This is as shown
in Figure I.
The Nigerian Postgraduate Medical Journal, Vol. 19, No. 3, September, 2012
Effective referral system is crucial to ensure that
women with life threatening obstetric complications have
timely access to BEOC services18. This includes effective
emergency transport and communication. Health care
professionals at nearby primary and secondary health
facilities need to have personal linkage and exchange of
telephone numbers such that access to each other could
be improved.
Conclusion
The introduction of mgso4 to primary health
facilities would make available an evidence-based
treatment at the first point of call for women with eclampsia.
This report suggests that many lives may be saved by
this intervention and demonstrates the prospects for its
use at this level of care. However, caution is required as
good and effective linkage between two nearby health
facilities cannot be compromised if mgso4 would be safely
used at primary health facilities. A larger study, preferably,
a randomised control trial is recommended to further
evaluate the prospects of the use of MgSO4 at primary
health care delivery facilities.
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148 The Nigerian Postgraduate Medical Journal, Vol. 19, No. 3, September, 2012