Download 6. 1Need for the study - Rajiv Gandhi University of Health Sciences

Rajiv Gandhi University of Health Sciences
Bangalore, Karnataka.
Proforma for registration of subjects for dissertation
1. Name of candidate
Address
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Dr. Rose Mary (Sr. Rose Mary T)
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Post Graduate student
Dept of Obstetrics and Gynaecology
St. Johns National Academy of
Health Sciences,
Bangalore,-560034
Karnataka
2. Name of the institute
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St. Johns National Academy of
Health Sciences
3 Course of study, Subject
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MS. Obstetrics and Gynecology
4. DOA to the course
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21-3-2011
5. Title of the topic
Influence of maternal Genital flora
on early onset neonatal sepsis.
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6.Brief resume of the intended study:
6. 1Need for the study:
The human vagina is colonized by various microorganisms which may be normal flora or potential pathogens. Lactobacilli
are the predominant organisms 70% of which are found in the cervix and
vagina of healthy pregnant and non pregnant women [1, 2]. Because of their
production and tolerance of high acidity which limit the growth of other
bacteria, Lactobacilli are regarded as normal flora. Staphylococcus
epidermidis and diphtheroides also found in significant percentages (3060%) in pregnant women are inert in nature. Other organisms which are
considered as potential pathogens are group D Streptococcus .(10-40%), α
and β Hemolytic Streptococcus (-25%), Candida species (20-30%) E.Coli
(5-20%) Nisseria species (5-20%), Proteus < 10% and Staphylococcus
Aureus (<5%)
The vaginal carriage of communal bacteria and changes in the
equilibrium of the vaginal flora can induce complications and cause fetal
contaminations. Infection due to bacteria, virus or parasite are frequent
during pregnancy and can have severe consequences.(Judlin and
Thiebaugeorges.,2005; Nandyal,2008) Infection of the vagina and uterine
cervix are some of the most frequently diagnosed and treated complications
during pregnancy(Kazimierak
et al;2007;Namavar Jaharomi et al
;2008).bacterial infection remain a major cause of morbidity and mortality
in new born infants(Balaka et al;2005)3,4
Neonatal sepsis may be categorized as early or late onset. 85% of
newborn with early onset infections present within 24hours, 5%present at
24-48 hours and a small percentage at 48-72 hours.
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Early onset neonatal sepsis is associated with acquisition of
microorganisms from the mother, through transplacental infection, or an
ascending infection from the cervix , or may be caused by organisms that
colonize the mothers’ genito urinary tract(Balaka et al;2003; Veleminsky
and toser 2008;Ungureanu;2008) They are infected by passage through a
colonized birth canal at delivery. Microorganisms currently associated with
sepsis include group β Strepthococcus, E.Coli, Coagulase negative
Staphylococcus, H. Influenzae, Listeria.[5]
Neonatal sepsis its diagnosis and therapy remain an important
problem for Obstetricians and Pediatricians alike.
Dr. Steven S Wilkin says, “Infectious causes of preterm delivery and
the resulting perinatal morbidity and mortality remain a major problem in
both developed and developing countries. There is an urgent need to find
out more about how individual microbial pathogens cause their adverse
effects, define critical areas of research, and highlight specific examples
where improved clinical interventions can be introduced.
The present study is undertaken to find out the influence of maternal
genital flora on early onset neonatal sepsis.
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6. 2 Review of Literature:
In spite of recent advances in antenatal care and treatment, maternal
genital infections still constitute a hazard to the mother and her child .The
incidence of neonatal sepsis according to the data from National Neonatal
Perinatal Database (NNPD,2002-03)is 30 per 1000 live births .The data
comprising 18 tertiary care neonatal units across India found sepsis to be
one of the commonest causes of neonatal mortality contributing to 19% of
all neonatal deaths.(6)
Neonatal sepsis can be classified in to two major categories
depending on the onset of symptoms .Early onset neonatal sepsis presents
with in 72hrs of life. The source of infection is maternal genital tract
John Akerele et al studied the prevalence of asymptomatic
genital infections among pregnant women in 2002. HVS collected from 500
consenting women attending antenatal clinic at Nigeria. A Total of 300
specimens showed significant microbial growth, giving a prevalence of 60%
for assymptomatic genital infections. Candida(65%),Staphylococcus aureus
(51.8%) and Enterobacteria were isolated followed
by Trichomonas
vaginalis, and Neisseria gonorrhea.(7)
Betty Chaco et al CMC Ludhiana Punjab 2005
done a study on the maternal risk factors and clinico-bacteriological
profile of early onset neonatal sepsis (EOS)in tertiary care neonatal unit. The
incidence of EOS was 207/1000 live births .Among the perinatal risk
factors a significant association of EOS with prolonged rupture of
membranes, foul smelling liquor ,and maternal urinary tract infection
observed(p<0.05).Incidence of
EOS was negligible in the absence of
maternal risk factors. Culture proven EOS occurred in 41.6% Pseudomonas
being the common (60%) isolates.(8)
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A study was done by Dr. Basavaraj M Kerur and B Vishnu Bhat at
JIPMER in 2006 at Pondicherry. Their study was intended to evaluate the role of
maternal genital bacteria and baby’s surface colonization in early onset of neonatal
sepsis.(9)
Results were E.Coli was most common organism isolated from
maternal genital tract and surface culture of babies, but Klebsiella was most
common organism isolated from their blood. There was significant correlation
between surface colonization of babies and maternal genital bacteria so also was
baby’s surface culture and blood culture.
AK .MANE et al did a study 2009 on neonatal septicemia in tertiary care
hospital in rural Nagpur. In clinically suspected cases of neonatal septicemia blood
culture samples were positive in 70% of samples ,of these 48% EOS and 22%
LOS (late onset sepsis) .In EOS ,K.Pneumonia, S.Aareus, were predominant(10)
Camelia budisan et al in their study in 2009 To determine bacterial ecology of
genital organisms in the last trimester of pregnancy and its association with
early onset neonatal sepsis.(11) concluded that , in 8 out of 22 cases of EOS
,pathogens isolated from blood are E.coli , Group b Steptoccoci, Staph areus ,
Klebsiella, Haemophilus influenza.(11)
6.3 Objectives of the study
A. Primary objective- To determine the maternal vaginal flora in the
last trimester of pregnancy.
B. Secondary objective- To study the influence of vaginal flora in early
onset neonatal sepsis.
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7. Material and Methods:
7.1. Study design:
Prospective study will be conducted in pregnant women in their third
trimester at SJMCH, Bangalore.
7. 2. Sample size and source of data:
In order to examine the association between umbilical swab and
mother’s cervical swab, based on the paper by Kerur et al a sample size
of 140 mother infant pair need to be examined. Considering 80% power
and 5% level of significance. So 150 pregnant women In the third
trimester of pregnancy yet 37-40 weeks of gestation, During antenatal
checkup or admitted to the labour ward before the onset of labour at St.
John’s Medical college Hospital.
Regression Methods- Sample size for correlation co-efficient analysis.
Sample correlation co-efficient =.5
Population correlation coefficient= .3
Power (%)= 80
Alpha error(%)=5
Sided =2
Sample size n=140
7. 3. Duration of study
2 years between sep 2011-mar 2013
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7.4 . Inclusion Criteria:
Normal pregnant women attending antenatal clinic at SJMCH in third
trimester of pregnancy and delivering at same hospital.
Exclusion criteria
 Antibiotic use proceeding one month.
 Plan to deliver in other hospital
 Prior use of tocolytic agents during current pregnancy
 Cervical encirclage
 Multiple gestation
 Symptomatic heart disease
 IDDM
 Known case of renal disease (Serum creat >2.5 mg/dl
7.5 .
Method of collection of data:
Pregnant women attending the outpatient department or admitted to labour
ward
during the third trimester of pregnancy in SJMCH will be studied.
 Informed consent will be obtained from all these cases.
 During the visit the women will be put in dorsal position for
per
speculam examination. A clean bivalve speculum will be placed deep in
the vagina and HVS(High vaginal swabs) taken near the fornices with
sterile cotton tipped swabs.
 HVS will be sent to the microbiology lab which will be processed and
the organism identified as per the standards of the lab.
 All these women will be followed up during delivery. A detailed history
will be obtained which include antenatal checkups, treatment received
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in other hospitals, maternal fever within one week of delivery, history
suggestive of UTI and intra uterine infections, any medical illness,
Anemia, quality of liquor, duration of labour, mode of delivery, APGAR
score, mode of resuscitation. Soon after delivery infants umbilicus, will
be swabbed to look for superficial colonization. They will be followed
till the time of discharge and will be looked for clinical manifestation of
sepsis like poor cry ,refusal to suck ,lethargy, grunt, tachypnea, cyanosis,
temperature, seizures, abdominal distension. In suspected cases of sepsis
septic screening which include total count, differential count ,ESR ,CRP
,CSF .Urine ,Blood and other appropriate cultures will be collected.
 The distribution of organisms isolated from mothers genitaltract and
organism isolated from babies will be expressed in numbers and
percentages and will be correlated by calculating phi correlation
coefficient.
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Informed consent form:
Title of the study:
Genital flora during the last trimester of pregnancy and its association in early
onset of neonatal sepsis
I the undersigned agree to have a HVS taken while I am being examined during
the antenatal check up.
I have no objection to the analysis that will be done on the bacteria that are
isolated which will be useful for me and perhaps for preventing spread of these
bacteria in the community.
Study subject
Study investigator
Name and signature
Name and signature.
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I. References
1. Rudolf Galsk, et al, vaginal flora and its roles in disease entities. Clinical
obstetrics and Gynecology 1976; 19 (1); 61- 82
2.Richard H,SCHWARZ; management of post operative infection in Ob And
Gynecology, Clinical Obstetrics and Gynecology;1976;19(1)97-99
3. Pamela A Davies, Maternally transmitted bacterial infection in neonate.
Internal Medicine Australian Edition.
4.Balaska,B,Agbere;a;Dagnra,A;baeta,S;Kessie,k;Assimadi,K
2005Genital
bacterial carriage during the last trimester of pregnancy and early onset
neonatal sepsis. Arch Pediatr 12(5);514-519
5.Balaska,B,Agbere;a;Dagnra,A;baeta,S;Kessie,k;Assimadi,K2003.Bacterial
flora in the genital tract in the last trimester of pregnancy J. Gynecol Obstet
Biol Reprod 2 (6);555-61
6. Report of the National Neonatal Perinatal Database (National Neonatology
Forum) 2002-03.
7 Klein J, Mercy M. Bacterial sepsis and Meningitis. In Remington J,
Klein J
Infectious Disease of the fetus and newborn infant Ed. 4
Philadelphia WB Saunders 1995, 835 -890
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.Beargie R, Precilla L, Elon T, John D. Perinatal infection and vaginal
flora. A J Obstetric and Gynecolgical 1975;122: 31 - 33
9. Betty Chacko and Inderpreet sohi
Maternal risk factors and clinic
bacteriological profile of early onset sepsis ;Indian J Pediatr 2005;72;(1);2326
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10. Basavaraj M. Kerur ,Maternal Genital Bacteria and Surface Colonisation
in Early Neonatal Sepsis.(Indian J pediatr 2006;73(1):29-32)
11..kManeet al Journal of recent Advances in applied sciences(JRAAS
25;19- 24
2010)
12.Camelia Budisan Constantin Ilie Victor babes University of medicine and
pharmacy Timisoara, Romania 2009.Influence of maternal vaginal aerobic
flora on newborn early infections. Jurnalul Pediatrului year 12 vol 13Nr4546 Jan-June2009.
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Does the study require any investigations or interventions to be conducted on
patients or other humans or animals
Yes.
Has ethical clearance been obtained from your institution
Yes.
Signature of candidate
Remarks of the Guide
Name and Designation of guide
DR.ANNAMMA THOMAS
PROFSSOR AND HOD
DEPT OF OBG
ST.JOHN MEDICAL COLLEGE ,
BANGALORE-560 034
Signature
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CO-GUIDE
DR.SWARNA REKHA (DPT OF PEDIATRICS)
ST.JOHNS MEDICAL COLLEGE
BANGALORE 560 034
Signature
DR. MURALIDHARAN (DPT OF MICROBIOLOGY)
ST.JOHNS MEDICAL COLLEGE
BANGALORE -560 034
Signature
Head of Department
DR.ANNAMMA THOMAS
PROFESSOR AND HOD
DEPT OF OBSTETRICS AND GYNACOLOGY
ST.JOHNS MEDICAL COLLAGE
BANGALORE-560 034
Signature
Chairman and Principal
REMARKS
SIGNATURE
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