Asha Xavier

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					   RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
            KARNATAKA, BANGALORE

                       ANNEXURE II

   PROFORMA FOR REGISTRATION OF SUBJECTS FOR
                 DISSERTATION


1. NAME OF THE          DR. AISHA HUMERA,
CANDIDATE AND           D/O ABDUL QAYUM SAGRI,
ADDRESS (IN BLOCK       199/3, MMTC COLONY, JP NAGAR,
LETTERS)                BELLARY ROAD, HOSPET – 583201


2. NAME OF THE          YENEPOYA MEDICAL COLLEGE,
INSTITUTION             DERALAKATTE,
                        MANGALORE.

                        POST GRADUATE,
3.COURSE OF STUDY       M.S. (OBSTETRICS AND
AND SUBJECT             GYNAECOLOGY)


4. DATE OF ADMISSION    24TH APRIL 2007
TO COURSE


5. TITLE OF TOPIC       ONE YEAR PROSPECTIVE
                        RANDOMISED COMPARATIVE STUDY
                        OF ORAL MISOPROSTOL VERSUS IV
                        METHYL ERGOMETRINE IN
                        PREVENTION OF POSTPARTUM
                        HAEMORRHAGE IN CASES HIGH RISK
                        FOR POSTPARTUM HAEMORRHAGE.
6. BRIEF RESUME OF THE INTENDED WORK:
6.1 Need for the study :-
   Maternal mortality rate in India is estimated to be 407 per 100,000 live births out of
which 30% deaths are due to postpaturm haemorrhage. 80% of Indian population reside
in rural areas and about 50% - 60% of the deliveries are home deliveries, especially in
resource – poor set ups where no proper medical facilities such as medical or paramedical
personnel, facilities for blood transfusion, transportation facilities in cases where referral
is needed. Moreover in such areas recognition of high risk cases are hardly done.
Although effective methods for prevention and treatment of such haemorrhage exist –
such as the uterotonic drug oxytocin – most are not feasible in resource – poor settings
where many births occur at home. We aimed to investigate whether oral misoprostol
which is proved safe, effective and also potential alternative to other oxytocics could
prevent post partum haemorrhage in a community home – birth settings, in patients with
high risk for post partum haemorrhage eg – multiple gestation, multiparity etc.


6.2 Review of Literature:
In a randomize placebo controlled study1 conducted at J.N. Medical College, Belgaum in
Collaboration with National Institute of Child Health and Human Development, U.S.A.
(600µg of oral misoprostol V/s placebo) it was concluded that oral misoprostol was
associated with a significant difference in rate of acute post partum haemorrhage (12.0%
- 6.4% - P< 0.0001) and also with a fall in mean post partum blood loss (262.3ml-
214.3ml P<0.0001). Post partum haemorrhage rates remained significantly higher in
placebo groups. However oral misoprostol group had higher rates of transitory
symptoms of chills (52.2% - 17.3%) and fever (4.2% - 1.1%) than the control group.
A prospective randomized controlled hospital based trial2 conducted at Christian Medical
College, Vellore, to compare the efficacy of 400µg oral misoprostol with that of 0.2mg
IV ergometrine and 10 U IM oxytocin in low risk group. It was observed that rates of
blood loss between 500ml and 1000ml, mean blood loss, need for additional oxytocin
drugs and fall in haematocit values should no statiscally significant difference. However
misoprostol group had higher incidence of hyperpyrexia >99ºF (6.7%, 0.7%, 2.0%) and
shivering (7.4%, 2.1%, 3.7%) compared to other Oxytocics. Therefore it was concluded
that oral misoprostol is as effective as conventional Oxytocic agents in preventing
postpartum haemorrhage and can be recommended for use in low resource settings.
A randomized controlled trial3 conducted by Caliskan et al to compare oral misoprostol
V/s oxytocin either alone and in combination with Oxytocin or Methergine concluded
that oral misoprostol alone is as effective as Oxytocin alone for the prevention of post
partum haemorrhage. However combinations with Oxytocin are more effective so far as
primary outcome measured in terms of incidence of postpartum haemorrhage (3.2%-9%)
and fall in haemoglobin concentration 24hrs after delivery.
 A prospective multicentric, randomized controlled trial4 conducted in tertiary training
centres by ASM Chan et al. using 600 µg oral misoprostol v/s 1ml IM syntometrine (5U
Oxytocin + 0.5 mg ergometrine) observed that there was no significant difference in
amount of estimated blood loss (≥500ml and ≥1000ml) and fall in mean haemoglobin
concentration (32.7%- 32.9%) in both the groups. However incidence of pyrexia and
shivering (4.4%-1.8%) was higher in misoprostol group. But one important observation
in this study was incidence of manual removal of placenta was significantly lower in
misoprostol group (P< 0.05) with a R.R. of 0.29 (95% CI 0.09-0.87)
A randomized double blind clinical trail5 conducted in university teaching hospital by F.
Amant et al to compare efficacy and safety of 600µg oral misoprostol V/s 0.2 mg IV
methyl ergometrine for prevention of post partum haemorrhage in low risk cases. It was
observed that incidence of postpartum haemorhage was similar in both the groups
(P=0.57), need for additional Oxytocics drugs was high in misoprostol group as
compared to ergometrine group (44% - 12.8%) and higher incidence of side effects were
observed in misoprostol group. However haemoglobin level on third postpartum day was
same in both the groups.
7.0 Material and Methods :
One year randomized comparative study of cases high risk for post partum haemorrhage
in Yenepoya Medical College and Hospital, Mangalore. From November 2007 – October
2008.
7.1 Source of data:
One year randomized comparative study will be carried out in cases high risk for
postpartum haemorrhage fulfilling the following inclusion criteria admitted at Yenepoya
Medical College and Hospital ,Mangalore.
Inclusion criteria
   1. Multiplarity
   2. Moderate to severe anemia (<6gm%)
   3. Multiple fetal gestation
   4. Hydramnios
Exclusion criteria :
   1. Pregnancy complicated with medical disorders like diabetes, bronchial asthma,
        hypertension, epilepsy, cardiac disease .
   2. Previous caesarean section
   3. Placenta praevia
   4. Abruptio placenta
   5. Previous h/o retained placenta
   6. Pregnancy induced hypertension.
A Power analysis is performed on the basis of results of previous study2,”Sample size is
calculated by applying the following formula:
n= { 4sigma2 }/L2
n= sample size
sigma= standard deviation
L= allowable error taken as 20% 0f S.D
n= 4×131×131 / 26.2×26.2
n =99
sample size is rounded to 100
7.2 Methods of collection of data:
After obtaining approval of ethical committee, women who fulfill the inclusion criteria
will be included in the study. Written informed consent will be taken on admission to
labour ward. All patients participating in study will undergo Hemoglobin concentration,
packed cell volume, before and 48 hours after delivery. Randomization of patient is based
on a table of computer – generated blocks of random numbers into two groups. Group I
receiving 600µg oral misoprostol and group II 0.2mg IV methyl ergometrine following
delivery of anterior shoulder of baby. The following parameters are observed & recorded.
Parameters observed:
    1. Amount of blood loss within 2hrs. of delivery (≥500ml and ≥1000ml ).
    2. Use of additional Oxytocic drugs/other measures to treat PPH (Packing of uterus,
         hysterectomy. Iliac artery ligation)
    3. Occurrence of side effects like nausea, vomitting, diarrhoea, headache, fever and
         shivering.
    4. Decrease in hemoglobin concentration from before to 48 hrs after delivery.
The amount of blood loss is assessed by clinical estimation by noting the - complete
blood loss, by collection of blood lost after all the amniotic fluid had drained out in third
stage by using plastic sheet, noting the difference in the weight of dry and soaked drapes
and pads, weighing the blood clots and measuring collected blood using measuring jar.
Data will be expressed as mean ±SD in the table. The two group will be compared using
appropriate statistical test- students „t‟ test for continuous variables, χ2 test for categorical
data and P<0.05 will be considered significant.
7.3 Does the study require any investigations or interventions to be conducted on
patients? If so briefly describe.
Routine obstetrical investigations: blood group +Rh typing, Hemoglobin estimation and
packed cell volume prior and 48 hours after delivery,HIV, HBsAg, VDRL, urine routine,
sonography to document gestation, presentation, amniotic fluid index.
Administration of drugs – 600µg oral misoprostol,
                            0.2mg IV methergine
7.4 Has the ethical clearance been obtained from institution in case of 7.3?
   Yes
8 REFERENCES:




  1. Prof Richard J Derman, et al.”Oral misoprostol in preventing postpartum
     haemorrhage in resource - poor communities: a randomized controlled trail”. The
     Lancet, 2006;368:1248-1253.


  2. E S Zachariah, M.Naidu,et al.”Oral misoprostol in the third stage of labour”
     ,IJOG,2006;92:23-26


  3. Caliskan E, Dilbaz B et al.” Oral misoprostol in third stage of labour: a
     randomized control trial.” Obstetrics and gynaecology,2003;101:921-928.


  4. P S Ng, A S M. Chan et al. “ A multicentre randomized controlled trial of oral
     misoprostol and IM syntomentine in management of the third stage of labour.”
     Human Reproduction,2001;16:31-35.


  5. F Amant, B Spitz, et al. “Misoprostol compared with methyl ergometrine for
     prevention of postpartum haemorrhage.: a double blind randomized trial” BJOG,
     1999;106:1066-1070.
8.0 SIGNATURE OF THE CANDIDATE:

 9.0 REMARKS OF THE GUIDE:- Misoprostol has been evaluated by many
researchers for prevention and treatment of postpartum haemorrhage in low risk cases for
postpartum haemorrhage ,where it has been proved to be as effective as other oxytocic
drugs. However its efficacy in high risk groups has been hardly evaluated and its route of
administration being oral it overweighs the other oxytocic drugs which has to be
administered by parenteral route.hence in my opinion such study is essential.

10.0 NAME AND DESIGNATION:


10.1 GUIDE:-                                    DR.PUSHPA AWASEKAR,

                                      Professor In Dept. Of obstetrics and gynaecology



10.2 SIGNATURE:-

10.3 CO-GUIDE:

10.4 SIGNATURE:


10.5 HEAD OF THE DEPARTMENT:                     DR.BHARATHI. V. BALIGA

                                                         Professor & HOD

                                           Department of Obstetrics and Gynaecology


10.6 SIGNATURE:

11.1 PRINCIPAL:-                                  DR.R.N.SUJEER.


                                           Professor in the department of surgery.

11.1 REMARKS OF PRINCIPAL: -


11.2 SIGNATURE:-

				
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posted:11/12/2011
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