jurnal ttrial sce3
TRANSCRIPT
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Vitamin C And Vitamin ESupplementation In Pregnant WomenAt Risk For Pre Eclampsia : ARandomized Controlled Trial.
AstractEvidence suggests that antioxidant supplementation reduces risk of preeclampsia. Our aim
was to investigate the potential benefit of antioxidants in women with risk factors of
preeclampsia. A total of 285women identified at risk of preeclampsia were administered
vitamin C !!! mg" vitamin E 2!!mg # placebo from 2 weeks of pregnanc$ till deliver$ in
intention to treat. %he patients were randoml$ assigned to drug groups. %he &ncidence of
preeclampsia" intrauterine growth retardation" and caesarean between placebo and vitamin
group were compared and were found to be same. 'ut preterm birth reduced in statisticall$
significant number in vitamin group (O) * !.28" C& * !.2 + !.,," p * !.!-.
Introductionre+eclampsia is a multis$stem disorder characteri/ed b$ h$pertension and roteinuria
occurring in second half of the pregnanc$. %his condition is best described as a pregnanc$
specific s$ndrome of reduced organ perfusion secondar$ to vasospasm and endothelial
activation.%he exact incidence of pre+eclampsia is unknown" but about 50 pregnant
women develop pregnanc$ induced h$pertension. Out of this 150 will have one maor
complication.2" Eclampsia is responsible for nearl$ 20 of all maternal mortalities in
world2and .80 mortalit$ in 34. As per ational 6amil$ 7ealth urve$ 2!!5+2!!9
&nternational institute of population ciences :umbai (2!!;-" !.10 women will have
convulsions. 'ecause of the seriousness of the condition studies to find means of
preventing and treating pre+eclampsia are ver$ important. 7$pertension along with
hemorrhage and sepsis forms the deadl$ triad responsible for maorit$ of maternal deaths.
%here is increasing evidence that pre+eclampsia is associated with both increased oxidative
stress and reduced antioxidants defenses. Circulating levels of oxidative stress markers
have been found to be elevated and that of antioxidants depressed in women with pre+
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eclampsia compared to women without the disorder.1" these observations on the effects of
oxidative stress in pre+eclampsia have given rise to increase interest in the potential
benefits of antioxidant therap$ given for the prevention of h$pertensive disorders of
pregnanc$. Antioxidants are a diverse famil$ of components that function to prevent
overproduction of and damage caused b$ noxious free radicals. Examples of antioxidantsinclude
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re+eclampsia is associated with both increased oxidative stress and reduced antioxidants
defenses. Circulating levels of oxidative stress markers have been found to be elevated and
that of antioxidants depressed in women with pre+eclampsia compared to women without
the disorder. %hese observations on the effects of oxidative stress in pre+eclampsia have
given rise to increase interest in the potential benefits of antioxidant therap$ given for theprevention of h$pertensive disorders of pregnanc$. Antioxidants are a diverse famil$ of
components that function to prevent overproduction of and damage caused b$ noxious free
radicals. %his stud$ is designed to test the h$pothesis that treatment of pregnant women
with antioxidants would alter endothelial cell inur$ linked to preeclampsia reducing the
incidence of h$pertensive disorder during pregnanc$.
'et&ods
%he stud$ was conducted in the Bepartment of Obstetrics and $necolog$ of overnment
:edical College 7ospital" Chandigarh. %he present stud$ was prospective randomi/ed
control interventional trial conducted during the period extending from Dune 2!!9 to August
2!!;. A total of 285 primigravida attending antenatal clinic were enrolled#registered. %he
group &A was administered orall$ vitamin+C !!!mg and vitamin+E 2!!mg and was labeled
as intervention group (
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A&B (on steroidal anti+inflammator$ drug-. tatistical anal$sis was done b$ using
ormal test of proportions" Chi sFuare+test" Odds ratios along with ,50 confidence interval.
+2 software was used for conducting statistical anal$sis.
ResultsAt the outset with the aim of substantiating whether primi are at higher risk for various
complications like preeclampsia" preterm labor" &3)" ?C etc." their incidence in primi
was compared with multi+gravida mother without an$ intervention in either group. %here
were = cases of eclampsia out of total of !! multi gravida in contrast to cases in
primigravida (group &'-. ince among multi+gravida (group+&&- pre+eclampsia" as compared
to primi+gravida (group+&'- was significantl$ less even without intervention" this group && +
was excluded from further anal$sis. Out of =! primigravida registered as group &'" 8 were
lost to follow up and 9 delivered outside. %hus final anal$sis was for !, subects. Out of
total =5 primi+gravida registered and intended for intervention (&A group-" 9 lost to follow
up and 22 delivered outside. 7ence final anal$sis for !; subects was done. %he patients
of placebo and vitamin group were well matched economicall$ and educationall$" compared
to placebo group" vitamin group has less pre+eclampsia disorder but it was not statisticall$
significant (O) * !.==" p * !.2-. 7owever a chance association finding of reduced rate of
preterm birth (birth weight G 2.5 kg- was observed in supplemented group (O) * !.28" C& *
!.2 to !.,," p * !.!- which is statisticall$ significant. rowth retarded babies did not show
an$ statisticall$ significant reduction in supplemented group as compared to placebo group
(O) * !.,1" C& * !.18+2.1 " p * !.82" H2 * !.!1-.
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(Tale)*+ C!'PARISI!, !F C!'P-ICATI!,S !F PRE)EC-A'PSIA I, TW! R!/PS
0iscussion
%he overall incidence of pre+eclampsia was ;.!=0 which is in agreement with ;.90incidence observed b$ 7auth et al., Observing no significant difference in the incidence of
pre+eclampsia between vitamin and placebo group b$ present stud$ is in agreement with
other authors.5"" 9 %he latter group used same doses of
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support our results. &nterpretation of the results + taking into account our stud$ h$potheses
antioxidant did not lead to reduction in the rate of pre eclampsia in women" but can reduce
the rate of preterm deliveries.
Conclusion%he supplementation of vitamin E and vitamin C to pregnant women at risk of preeclampsia
did not alter the rate of development of preeclampsia" intrauterine growth retardation or the
rate of caesarean sections in this stud$.
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5. icolaos . ol$/os" Bavide :auri" :aria %sappi et al. Combined vitamin C and E
supplementation during pregnanc$ for preeclampsia prevention A s$stematic review.
Obstetrical and $necological urve$ 2!!;I92(1-2!2+2!9.
9. oston ?" 'rile$ A?" eed %" 4ell$ 6D et al.