Đề tieng anh thpt 2024 danh cho cac ban hoc sinh
saranya(1)(1).pptx
1. A Randomized control trial on
comparision of Ferric
carboxy maltose vs Iron
sucrose for treatment of Iron
deficiency anemia in
pregnancy
2. STUDY CONDUCTED BY
Dr.Saranya
First year pg
Department of obstetrics and gynaecology
SRMMCH & RC
PH NO :7305546712
GUIDE
Dr.Sajeetha kumari.R
professor
Department of obstetrics and gynaecology
SRMMCH & RC
PH NO :9940170195
CO-GUIDE
Dr.Sangeetha
Ass professor
Department of obstetrics and gynaecology
SRMMCH & RC
PH NO :9841339373
3. INTRODUCTION
• Anemia is a condition in which the number of red blood cells
or their oxygen carrying capacity is insufficient to meet the
physiological needs of the individual ,which consequently will
vary with age ,sex , attitude ,smoking and pregnancy status.
• Iron deficiency anemia is the most common medical condition
during pregnancy
• WHO defines anemia as hemoglobin less than 11 gm/dl
during pregnancy or hematocrit less than 32%.
• The main stay of iron supplementation is either oral or
parenteral.
• This study was designed to compare iron sucrose vs fcm for
the treatment of iron deficiency anemia in 20-34 weeks of
pregnancy
4. AIM
To study the efficacy & safety of FCM vs
iron sucrose in treating mild to moderate
anemia at 20-34 weeks of pregnancy
5. OBJECTIVES
• To study the efficacy & safety of ferric carboxy maltose in the
treatment of mild to moderate anemia at 20-34 weeks of
pregnancy
• To study the efficacy & safety of iron sucrose in the treatment
of mild to moderate anemia at 20-34 weeks of pregnancy
• To compare the efficacy & safety of FCM vs iron sucrose
in treating mild to moderate anemia at 20-34 weeks of
pregnancy
6. HYPOTHESIS
FCM is safe ,and has lesser adverse
effects and better compliance in the patient.
7. MATERIALS AND METHODS
• Study design: Randomized control trial
• Study population: Antenatal women attending
the OG OPD of SRM Medical College
• Study place: Department of OG ,SRM Medical
College Hospital and Research Center
• Study period : September 2021 to November
2022
• Sample Size, n = 100 in each group
8. n >= [(Z1- α/2 + Z1-β)² (σ1²+σ2²/r)] / (µ1-µ2)²
● Alpha (α) - Type I error rate
● Beta (β) - Type II error rate
● µ1 - Expected Mean of the outcome in group 1
● σ1 - Expected Standard Deviation of outcome in
group 1
● µ2 - Expected Mean of the outcome in group 2
● σ2 - Expected Standard Deviation of outcome in
group 2
● r - Sample Size Ratio = g2/g1 = 1
9. STUDY CRITERIA
• INCLUSION CRITERIA:
Antenatal women in the age group 18- 35 years
Singleton pregnancy
Mild to moderate degree of iron deficiency anaemia
Refractive to oral Iron Therapy
Gestational age between 20-34 weeks of gestation
Women willing to participate
• EXCLUSION CRITERIA:
Anaemia due to other causes
Multiple pregnancy
Previous history of blood transfusion
Chronic infections like hepatitis and HIV
History of bleeding disorders
Medical disorders like liver disease, renal disease ,cardiovascular
disorders
Hypersensitivity reaction to any iron preparation
10. METHODOLOGY
• Pregnant women attending the antenatal
clinic between 20-34 weeks of gestation
was screened for the study.
• Those with Hbbetweenbetween 7-10.9 gm/
dl and diagnosed as iron deficiency
anemia (IDA) was enrolled for the study
based on the inclusion & exclusion criteria.
• Informed written consent was taken from
all the patients before recruitment into the
study.
11. Iron requirement was calculated according
to Ganzoni score
Iron requirement (mg)= total iron deficit
(mg)= BW(kg)x target (11g/dl)- actual
Hb(g/dl)x0.24 + storage iron(1000)mg
12. • Pregnant women was randomized
using a computer-generated block
randomization table into two groups in a
1:1 ratio and will be administered either
FCM or Iron Sucrose.
• Group A was treated with ferric carboxy
maltose
• Group B was treated with iron sucrose
13. Assessed for eligibility n= 500
Randomization n= 54 in each
group
Fcm n= 54
Lost follow up =02
Iron sucrose n= 54
Lost follow up =4
Analyzed n=50
Analyzed n=52
Enrolled patients satisfying
inclusion criteria
N=108
14. • After calculating total iron deficit,
• Group A : Was administered i.v. FCM.
• Maximal dose per sitting was 500mgdiluted in
100ml normal saline after test dose and
administered as an IV infusion over 30min,1week
apart.
• Group B : Was administered IV Iron Sucrose as
100mg in 100mlNS in 30minutesafterthetestdose.
Max 4 doses within 2-4 days interval.
• Side effects : Headache, nausea, myalgia,
arthralgia, vomiting, epigastric discomfort and
anaphylactic reactions.
15. • All women was administered antihelminthic
therapy with tablet albendazole 400mgas a
single dose and 5mgFolic acid once daily.
• Any minor or major adverse effects was noted.
• All patients was followed up after 2,3 and 4
weeks of completion of treatment.
• Hb, RBC indices and serum ferritin was done at
each visit.
16. • Primary outcome was change in Hb,
Reticulocyte count level from baseline
after 4weeks.
• Secondary outcomes was
change in ferritin levels,
improvement in RBC indices
safety and side effects of treatment
17. STATISTICAL ANALYSIS
• The master chart showing basic parameters
was prepared
• Data was presented as number (%) or
mean±SD/median(min-max) as appropriate.
• Baseline categorical variables was compared
between the groups using Chi-square/Fisher’s
exact test and continuous variables will be
compared using Student’s t-test.
• All statistical analysis was carried out using
SPSS
• The level of statistical differences was taken as
value p<0.05
18. • FUNDING: self
• ANCILLARY SERVICES : Haematology
• DATA COLLECTION: Principal investigator
• CONFLICT OF INTEREST : NIL
• INTERVENTION :
Group A – FCM
Group B – Iron sucrose
20. EPIDEMOLOGICAL DATA FCM IRON SUCROSE P VALUE
Mean AGE 27.5±3.9 26.2±3.6
weight 57.3±4.8 57.4±5.8
BMI 20.5±1.5 20.5±1.8
Parity
Primi
multi
SOCIO ECONOMIC
STATUS
UPPER CLASS
UPPER MIDDLE
LOWER MIDDLE
UPPER LOWER
LOWER
Fcm n=52
Iron sucrose n=50
23. DATA FCM IRON SUCROSE P VALUE
Degree of anemia
7 – 7.9
8-8.9
9-9.9
>10
no. Visits for hospital
iron
Resource expenditure
24. • All our cases was belonging moderate anemia
• Mild anemia opted oral iron therapy
25. HEMOGLOBIN VALUES
HEMOGLOBIN GM/DL FCM IRON SUCROSE P VALUE
BEFORE TREATMENT 8.7±0.67 8.65±0.76
AFTER 2 WEEKS OF
TREATMENT
9.8±0.64 9.82±0.73
AFTER 4 WEEKS OF
TREATMENT
10.8±1.37 10.2±1.34
MEAN RISE OF
HEMOGLOBIN
28. MEAN PCV VALUES
MEAN FERITTIN VALUES FCM IRON SUCROSE P VALUE
BEFORE TREATMENT 27.8±2.58 28.95±3.01
AFTER 2 WEEKS OF
TREATMENT
31.2±2.62 32.134±20.1
AFTER 4 WEEKS OF
TREATMENT
34.5±2.27 33.69±4.8
30. MEAN CORPUSCULAR
VOLUME VALUES
MEAN CORPUSCULAR
VALUES
FCM IRON SUCROSE P VALUE
BEFORE TREATMENT 77.1±5.8 74.72±11.2
AFTER 2 WEEKS OF
TREATMENT
81.5±5.5 80.7±9.38
AFTER 4 WEEKS OF
TREATMENT
86±12 89.3±5.7
32. MCH VALUES
MEAN CORPUSCULAR
VALUES
FCM IRON SUCROSE P VALUE
BEFORE TREATMENT 24.8±5.8 23.25±1.2
AFTER 2 WEEKS OF
TREATMENT
27.6±5.5 26.5±3.38
AFTER 4 WEEKS OF
TREATMENT
31.8±12 31.7±2.7
34. MCHC VALUES
MEAN CORPUSCULAR
VALUES
FCM IRON SUCROSE P VALUE
BEFORE TREATMENT 30.3±5.8 29.8±1.2
AFTER 2 WEEKS OF
TREATMENT
33.5±3.5 32.5±3.38
AFTER 4 WEEKS OF
TREATMENT
36.1±1.2 34.9±2.7
35. 0 AFTER 2 WEEKS AFTER 4 WEEKS
FCM 30.3 33.5 36.1
IRON SUCROSE 29.8 32.5 34.9
30.3
33.5
36.1
29.8
32.5
34.9
0
5
10
15
20
25
30
35
40
MCHC VALUES
FCM IRON SUCROSE Linear (FCM)
36. MEAN FERITTIN
VALUES
MEAN FERITTIN VALUES FCM IRON SUCROSE P VALUE
BEFORE TREATMENT 5.52±1.35 5.47±3.01
AFTER 2 WEEKS OF
TREATMENT
35.2±49.6 14.5±20.1
AFTER 4 WEEKS OF
TREATMENT
43.8±58.1 17.2±21.1
37. 0 2 weeks 4 weeks
fcm 5.52 35.2 43.8
iron sucrose 5.47 14.5 1.8
Column1
5.52
35.2
43.8
5.47
14.5
1.8
0
10
20
30
40
50
60
70
Mean ferittin values
fcm iron sucrose Column1 Linear (fcm)
38. TIBC VALUES
TIBC VALUES FCM IRON SUCROSE P VALUE
BEFORE TREATMENT 442±112 517±69.9
AFTER 2 WEEKS OF
TREATMENT
337±105 435±66.76
AFTER 4 WEEKS OF
TREATMENT
304±1.36 365±48.61
40. SERUM RE COUNT
VALUES
TRANSFERRIN
SATURATION
FCM IRON SUCROSE P VALUE
BEFORE TREATMENT 1.8±0.772 1.327±0.58
AFTER 2 WEEKS OF
TREATMENT
2.14±0.779 2.11±0.68
AFTER 4 WEEKS OF
TREATMENT
2.49±23.3 2.6±0.65
