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8/8/2019 Dissertation for e
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OBJECTIVES OF THE STUDY
The objective of the study was to:
• compare the efficacy of two conservative methods i.e. uterovaginal
packing and balloon tamponade in the control of Primary
Postpartum Haemorrhage
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OPERATIONAL DEFINITIONS
Efficacy was measured through:
• Success of control of bleeding
o If bleeding arrested within half an hour after uterovaginal
packing/balloon tamponade then approach adopted was
labeled as success
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MATERIAL AND METHODS
STUDY DESIGN:
• An experimental (clinical trials) study
STUDY SETTING:
•Department of Obstetrics & Gynaecology, Bahawal Victoria
Hospital, Bahawalpur.
DURATION OF STUDY:
• Six months after approval of synopsis.
SAMPLE SIZE:
• Sample size of 86 cases is calculated with 5% of level of
significance with Power of the test (I-β) 43%, control of bleeding
with uterovaginal packing (P1)=91%, Control of bleeding with
balloon tamponade (P2) 70%, 43 patients with uterovaginal packing
and 43 with balloon tamponade
SAMPLING TECHNIQUE:
• Non probability: purposive sampling
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SAMPLE SELECT ION:
INCLUSION CRITERIA:
The subjects selected for this study were included:
1. Cases with Primary PPH after vaginal delivery conducted in
hospital
2. Cases with Primary PPH after receiving uterotonics i.e.
Syntocinion Inj. Methergin, Prostaglandins
EXCLUSION CRITERIA:
1. Cases with bleeding disorders
2. Cases with ruptured uterus
3. Cases with retained products of conception or with genital tract
injuries
4. Cases on anticoagulant therapy
DATA COLLECTION PROCEDURE:
All the cases who developed Primary PPH in Obstetrics &
Gynaeology Unit-I after vaginal delivery fulfilling the inclusion criteria were
included in the study (Patient was diagnosed as having PPH by giving
pre-weighed pad, if bleed is more than 500ml).
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Cases were divided into two groups ‘A’ and ‘B’. After explaining
merits and demerits of study and taking informed consent all eligible
cases were offered two folded slips having letter ‘A’ and ‘B’ and were
asked to pick one of those to allocate the group on random basis. I
inserted sterilized roller gauze into the uterine cavity and vaginal canal for
24 hours under supervision of senior registrar in group ‘A’ and group ‘B’
were treated by insertion of Sengstaken-Blakemore oesophageal catheter
(S.BOC) in the uterine cavity and filled with saline upto 500ml for 24
hours. And study was approved by the ethical committee of BVH.
Data was collected through pre-designed proforma attached as
annexure-1. Proforma had two parts. First part contained socio-
demographic variables (age, parity) and second part contained
information regarding study variables (success of control of bleeding).
Parti-1 was completed when the patient was diagnosed to have
postpartum haemorrhage and second part comprising of study variables
i.e. success of control of bleeding was completed within half an hour.
DATA ANALYSIS PROCEDURE:
The collected data was analyzed accordingly by using SPSS
version 10. Frequency and percentages were computed for success of
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control of bleeding and compared the proportion of difference in success
of control of bleeding between two groups were measured by Chi-square
test. Mean and standard deviation was computed for quantitative variable
like age. Level of significance was 5%.
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RESULTS
In this study, a total of 86 patients were recruited after fulfilling the
inclusion/exclusion criteria to compare the efficacy of two conservative
methods i.e. uterovaginal packing and balloon tamponade in the control
of Primary Postpartum Haemorrhage.
In this research, majority of the patients were found between 21-30
years of age in both A & B groups, in Group-A 62.79%(n=27) and in
Group-B 55.81%(n=24), the subjects with 18-20 years of age in Group-A
were 11.63%(n=5) and in Group-B 16.28%(n=7) while 25.58%(n=11) of
Group-A and 27.91%(n=12) in Group-B were found between 31-44 years
of age. Mean and standard deviation was calculated it was found
28.65+5.72 in Group-A and 26.96+4.12 in Group-B. (Table No. 1) Table
No. 2 shows status of parity, majority fothe patients in both groups were
found with Para-3 i.e. 53.49%(n=23) in Group-A and 48.84%(n=21) in
Group-B while 20.93%(n=9) in Group-A and in Group-B 30.23%(n=13)
wee found with para 2 while 25.58%(n=11) in Group-A and 20.93%(n=9)
in Group-B were presented with para-4.
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The comparison of efficacy of uterovaginal packing and balloon
tamponade in controlling of PPH was compared and presented in Table
No. 3, where in Group-A, we found 88.37%(n=38) were found to be
effective and the bleeding was controlled and only 11.63%(n=5) were
found with bleeding controlled while in Group-B only 46.51%(n=20) were
found with control of bleeding and 53.49%(n=23) were found with
bleeding. P value was found 0.00, which shows significance in efficacy in
patients managed in Group-A.
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TABLE No. 1:AGE DISTRIBUTION OF THE SUBJECTS
(n=86)
Age in years
Group-A (n=43) Group-B (n=43)
No. of cases Percentag
e
No. of cases Percentage
18-20 05 11.63 07 16.28
21-30 27 62.79 24 55.81
31-44 11 25.58 12 27.91
Total 43 100 43 100
Mean andS.D.
28.65+5.72 26.96+4.12
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Age Distribution of the Patients
5
117
24
12
27
0
5
10
15
20
25
30
18-20 21-30 31-44
Age in years Group-A Age in years Group-B
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TABLE No. 2:
PARITY OF THE SUBJECTS(n=86)
Parity
Group-A (n=43) Group-B (n=43)
No. of cases Percentag
e
No. of cases Percentage
Para 2 09 20.93 13 30.23
Para 3 23 53.49 21 48.84
Para 4 11 25.58 09 20.93
Total 43 100 43 100
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9
13
2321
119
0
5
10
15
20
25
Para 2 Para 3 Para 4
Parity of the Subjects
parity Group-A parity Group-B
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TABLE No. 3:
EFFICACY OF UTEROVAGINAL PACKING ANDBALLOON TAMPONADE IN CONTROL OF PPH
(n=86)
Efficacy
Group-A
(n=43)
Group-B
(n=43)No. of cases Percentag
e
No. of cases Percentage
Yes 38 88.37 20 46.51
No 05 11.63 23 53.49
Total 43 100 43 100
P Value= 0.00
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