Rajiv Gandhi University of Health Sciences s116

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:-