Artificial Intelligence in OBGYN Keynote Address on 19th March 2022 at MOGS...Niranjan Chavan
Artificial Intelligence in OBGYN Keynote Address at the Mumbai ObGyn Society Golden Jubilee Annual Conference held at Hotel Trident, Nariman Point, Mumbai, India.
Thyroid disorders are common in pregnancy . This is potential treatable cause of bad obstetric history .Hypothyroidism and hyperthyroidism both should be screened for clinically as well as by laboratory tests .
Due to availability of Thyroid testing ,it is more easily diagnosed and Treated.
Hypothyroid mother if not adequately treated ,there is poor mental development of the baby.
Due to awareness more and more diagnosis is made .There should be universal screening for thyroidal illness in pregnancy .
Artificial Intelligence in OBGYN Keynote Address on 19th March 2022 at MOGS...Niranjan Chavan
Artificial Intelligence in OBGYN Keynote Address at the Mumbai ObGyn Society Golden Jubilee Annual Conference held at Hotel Trident, Nariman Point, Mumbai, India.
Thyroid disorders are common in pregnancy . This is potential treatable cause of bad obstetric history .Hypothyroidism and hyperthyroidism both should be screened for clinically as well as by laboratory tests .
Due to availability of Thyroid testing ,it is more easily diagnosed and Treated.
Hypothyroid mother if not adequately treated ,there is poor mental development of the baby.
Due to awareness more and more diagnosis is made .There should be universal screening for thyroidal illness in pregnancy .
Adenomyosis is a benign disease of the uterus characterized by ectopic endometrial glands and stroma within the myometrium.
It is associated with myometrial hypertrophy and may be either diffuse or focal.
treating anemia is a big challenge.oral iron therapy do not adequately treat IDA. IV ferric carboxy maltose (FCM)effectively treats IDA by circumventing the problem compliance of oral iron therapy.
Imapct of Thyroid disorder on Reproduction-DrSelim.pdfShahjadaSelim1
Thyroid disorders are the commonest endocrine disorders in all people, though less talked about.
Thyroid disease is the second most common endocrine disorder after diabetes in pregnancy but more common than Diabetes in the community.
Female related infertility accounted for 37% and combined male and female factors for 35% of the causes of infertility.
Case Based Panel Discussion on Menopausal healthSujoy Dasgupta
Dr Sujoy Dasgupta moderated a panel on "Case Based Panel Discussion on Menopausal health" in the CME on Menopausal Health, organized by the AICC RCOG (All India Coordinating Committee) East Zone, held in Kolkata in March, 2022
Identifying women with GDM is important because appropriate therapy can decrease maternal and fetal morbidity .
Can prevent two generations from developing diabetes in the future.
INFERTILITY: Failure to conceive within one or more years of regular unprotected coitus.
PRIMARY INFERTILITY: Patients who have never conceived
SECONDARY INFERTILITY : Previous pregnancies but failure to conceive subsequently
Adenomyosis is a benign disease of the uterus characterized by ectopic endometrial glands and stroma within the myometrium.
It is associated with myometrial hypertrophy and may be either diffuse or focal.
treating anemia is a big challenge.oral iron therapy do not adequately treat IDA. IV ferric carboxy maltose (FCM)effectively treats IDA by circumventing the problem compliance of oral iron therapy.
Imapct of Thyroid disorder on Reproduction-DrSelim.pdfShahjadaSelim1
Thyroid disorders are the commonest endocrine disorders in all people, though less talked about.
Thyroid disease is the second most common endocrine disorder after diabetes in pregnancy but more common than Diabetes in the community.
Female related infertility accounted for 37% and combined male and female factors for 35% of the causes of infertility.
Case Based Panel Discussion on Menopausal healthSujoy Dasgupta
Dr Sujoy Dasgupta moderated a panel on "Case Based Panel Discussion on Menopausal health" in the CME on Menopausal Health, organized by the AICC RCOG (All India Coordinating Committee) East Zone, held in Kolkata in March, 2022
Identifying women with GDM is important because appropriate therapy can decrease maternal and fetal morbidity .
Can prevent two generations from developing diabetes in the future.
INFERTILITY: Failure to conceive within one or more years of regular unprotected coitus.
PRIMARY INFERTILITY: Patients who have never conceived
SECONDARY INFERTILITY : Previous pregnancies but failure to conceive subsequently
Iron deficiency anemia is one of the most common disorders experienced by pregnant women when they enter their second trimester of pregnancy, so there are many ways that can be done to diagnose iron deficiency anemia and carry out management against this anemia.
ANEMIA IN PREGNANCY BY DR SHABNAM NAZ.pptxShabnam Shaikh
pathological condition in which the oxygen carrying capacity of red blood cells is insufficient to meet the body ‘s needs
The world health organization uses haemoglobin Concentration to define anaemia, below 120 g/l in nonpregnant Women and 110 g/l in pregnancy.
Anaemia in pregnancy is defined as
first trimester haemoglobin (Hb) less than 110 g/l
second/third trimester Hb less than 105 g/l
postpartum Hb less than 100 g/l
PREVALANCE-
40% of world ‘s population
(35% non-preg 51%pregnant)
56% in Pakistan
MORTALITY
40-60% IN Pakistan
18% in industerlised countries
Reason of anemia during pregnancy
Physiological hamodilution
Increase iron demand
Diminished intake of iron--- bcs of nvp
Disturbed metabolism
Pre-pregnancy health status
Excess demand. (Twin)
During pregnancy, iron requirements increase (due to expanding red cell mass and increasing fetal requirements)by 2.5 mg/day in the first trimester to 6.6 mg/day in the third trimester.
There is an increase in iron absorption from the gastrointestinal tract during pregnancy.
Folic acid requirements also increase in pregnancy due to increased red cell mass and the expanding feto–placental unit.
Vitamin B12 decreases in pregnancy (205–1025 pg/ml to 30–510 pg/ml in pregnancy). Despite lower concentrations, there is rarely, if ever, evidence of biochemical vitamin B12 deficiency.
gastrointestinal issues affecting absorption
short inter-pregnancy interval
Other :
parasitic diseases
micronutrient deficiencies
genetically inherited hemoglobinopathies
TYPES OF ANAEMIA DURING PREGNANCY
Physiologic
Pathologic:
1 . Hereditary causes
Thalassaemias , Sickle Cell. Haemoglobinopathies , Haemolytic anaemias , other type ofHaemgobinopathies.
2 .Acquired Causes
A . Nutritional---Iron deficiency anaemia
( microcytic hypocromic anaaemia , Folate deficiency anaemia ( megaloblastic anaemia ) , Vit B12 Deficiency anaemia ( Megaloblastic anaemia )
B . Anaemia due to bone marrow failure ( aplstic / hypo plastic
anaemia ).
C . Anaemia secondary to inflammation , chronic disease ,
malignancy.
D . Anemia due to acute / chronic blood loss.
E . Acquire hemolytic anemia.
IRON ABSORBTION
Dietary iron (heme and non heme)
- heme-animal blood flesh viseras
-Non heme-cerels, seeds, vegetables, milk eggs.
Factors increases iron absorbtion
Heme iron
Proteins
Meat
Ascorbic acid
Fermentation Ferrous iron
Gastric acidity
Alcohol
Low iron stores
Increase erethropiioetic activity(hight altitue,bleeding)
FACTROS DECREASES IRON ABSORBTION
Phytates
Calcium
Tennins, tea, coffee, herbal drinks
Fortified iron supplements
IRON LOSS
PHYSIOLOGIC FACTORS
Desquamation of cells( intestine, skin)
Menstruation
Delivery
Lactation
PATHOLOGIC FACTORS
Hookworms /other helmentis
Bleeding from GIT
Allergies
Occult blood loss, excess menses,APH
Pharmaco-kinetics of Iron
Normal diet contain about 14 mg of iron
Absorption of iron is 5-10%
Additional daily iron demand in early pregnancy 2-3 mg/day
In late pregnancy 6-7 mg/day
So daily su
Management of anaemia in pregnancy BY DR ALKA MUKHERJEE DR APURVA MUKHERJEE N...alka mukherjee
Prenatal vitamins typically contain iron. Taking a prenatal vitamin that contains iron can help prevent and treat iron deficiency anemia during pregnancy. In some cases, your health care provider might recommend a separate iron supplement. During pregnancy, you need 27 milligrams of iron a day.
Good nutrition also can prevent iron deficiency anemia during pregnancy. Dietary sources of iron include lean red meat, poultry and fish. Other options include iron-fortified breakfast cereals, prune juice, dried beans and peas.
The iron from animal products, such as meat, is most easily absorbed. To enhance the absorption of iron from plant sources and supplements, pair them with a food or drink high in vitamin C — such as orange juice, tomato juice or strawberries. If you take iron supplements with orange juice, avoid the calcium-fortified variety. Although calcium is an essential nutrient during pregnancy, calcium can decrease iron absorption.
How is iron deficiency anemia during pregnancy treated?
If you are taking a prenatal vitamin that contains iron and you are anemic, your health care provider might recommend testing to determine other possible causes. In some cases, you might need to see a doctor who specializes in treating blood disorders (hematologist). If the cause is iron deficiency, additional supplemental iron might be suggested. If you have a history of gastric bypass or small bowel surgery or are unable to tolerate oral iron, you might need intravenous iron administration. Oral iron is recommended as the first line treatment, with repeated checking of Hb at 2 to 3 weeks after starting treatment to assess compliance, correct administration and response to treatmentOnce Hb reaches the normal range, it is recommended that iron replacement should continue for three months and until at least six weeks postpartumIntravenous (IV) iron is recommended for women who could not tolerate or respond to oral iron, and for those with moderately severe to severe anemia (Hb ≤ 90 g/LHb be measured within 24 to 48 hours after delivery in women with blood loss more than 500 mL, those with uncorrected anemia detected during pregnancy or those with symptoms suggestive of anemia postnatallyOral iron is recommended for women with Hb <100 g/L postpartum, who are hemodynamically stable, asymptomatic or mild symptomatic
Anemia signs and symptoms include:
• Fatigue
• Weakness
• Pale or yellowish skin
• Irregular heartbeats
• Shortness of breath
• Dizziness or lightheadedness
• Chest pain
• Cold hands and feet
• Headache
Keep in mind, however, that symptoms of anemia are often similar to general pregnancy symptoms. Regardless of whether or not you have symptoms, you'll have blood tests to screen for anemia during pregnancy. If you're concerned about your level of fatigue or any other symptoms, talk to your health care provider.
Similar to Iron Deficiency Anemia in PregnancyRole of IV Ferric Carboxymaltose andits Impact on Neonatal Outcomes : Dr Sharda Jain (20)
The Newer Concepts In Endometriosis Management : Dr Sharda JainLifecare Centre
The Newer Concepts In
Endometriosis Management
ENDOMETRIOSIS IS ENIGMA
DIAGNOSTIC DELEMMA
DEBILITATING DISEASE QOL
PROGRESSIVE DISEASE
RECURRENCE IS BIG PROBLEM
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NO PERMANENT CURE
The exact prevalence of endometriosis is unknown, but estimates 10% in the general female population in India but up to 50% in infertile women
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The Newer Concepts forReduced Surgery to preserve fertility in Endometriosis
ENDOMETRIOSIS IS ENIGMA
DIAGNOSTIC DILEMMA
DEBILITATING DISEASE QOL
PROGRESSIVE DISEASE
RECURRENCE IS BIG PROBLEM
NO FINAL VERDICT ON CAUSE
NO PERMANENT CURE
The exact prevalence of endometriosis is unknown, but estimates 10% in the general female population in India but up to 50% in infertile women
Anemia Free India Gynaecologist to focuss on *12gm Haemoglobin at Delivery I...Lifecare Centre
Important Highlights
Prophylactic Iron and Folic Acid Supplementation in all six target age groups.
Intensified year-round Behaviour Change Communication (BCC) Campaign for:(a) improving compliance to IFA and deworming, (b) enhancing appropriate infant and young child feeding practices, (c) encouraging increase in intake of iron-rich food through diet and/or fortified foods (d) ensuring delayed cord clamping .
Testing and treatment of anaemia, using digital methods and point of care treatment, with special focus on pregnant women and school-going adolescents.
Addressing non-nutritional causes of anaemia
in endemic pockets with special focus on malaria, hemoglobinopathies and fluorosis
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Strategies for Luteal Phase in ART cycles
Endometrial Receptivity Array
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How to improve success rates in ART?
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Factors Influencing IVF Success Ist Part
Strategies for Improving Success Rates in ART Second Part
Innovations & Breakthroughs in IVF Part Three
OPEN DEBATE
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SOCIALEGG FREEZING : Dr Poorva Bhargav and Dr Sharda Jain
Introduction
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Ethnobotany and Ethnopharmacology:
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Iron Deficiency Anemia in PregnancyRole of IV Ferric Carboxymaltose andits Impact on Neonatal Outcomes : Dr Sharda Jain
1. Iron Deficiency Anemia in Pregnancy
Role of IV Ferric Carboxymaltose and
its Impact on Neonatal Outcomes
PAN DGF CME
1st July 2023
2. Speaker
Dr Anjila Aneja
MD, DNB, MRCOG ,FRCOG (UK), Diploma in Pelvic Endoscopy
Senior Director Obst , Gynae & MAS Gynae at Fortis la Femme
3. • WHO – 32.4 million pregnant women suffer from anemia worldwide
• 0.8 million women are severely anemic
• 50% cases are attributed to Iron deficiency anemia
• 5,91,000 perinatal deaths and 1,15,000 maternal deaths attributed to iron
deficiency anemia directly or indirectly
• Low SES , High parity, endemic malaria, phytate rich Indian diet, nutritional
deficiencies, helminthic infections and inflammatory and infections ds further
increase the IDA in pregnancy
4. • Anemia – qualitative or quantitative reduction in the oxygen carrying capacity
of blood usually resulting from reduced hemoglobin that leads to reduced
oxygen supply to peripheral tissues
WHO defines Anemia in pregnancy as
- Hb < 11gm/dl
- PCV < 33%
- PP patients Hb < 10g/dl
5. Anemia During Pregnancy
Hemoglobin (g/dL)
CDC < 11 ( 1st trimester)
< 10.5 (2nd trimester)
< 11 (3rd trimester)
WHO < 11
WHO classification of severity of anemia in adult females
[ Hemoglobin in g/dL]
Mild Moderate Severe
Non pregnant
women(age >15
years or above)
11–11.9 8–10.9 < 8
Pregnant
women
10–10.9 7–9.9 < 7
Indian J Hematol Blood Transfus. 2018:1-2.
Anemia During Pregnancy: Forming a Consensus
ICMR 10-10.9 7-10 <4
6. Physiologic (dilutional) Anemia
• Physiologic changes during pregnancy result in dilutional anemia despite an overall increase
in red blood cell mass.
• Plasma volume increases by 10 to 15 percent at 6 to 12 weeks of gestation, expands rapidly
until 30 to 34 weeks, and then plateaus or decreases slightly to term.
• The total gain at term averages 1100 to 1600 mL and results in a total plasma volume of
4700 to 5200 mL, which is 40 to 50 percent above that prior to pregnancy
• The RBC mass also increases, but to a lesser extent (approximately 15 to 25 percent).
• Physiological anemia
- >10 to 11 g/dL
- PCV>30
- RBC count > 3.2million
- RBC morphological normal
7. Milman N Ann Hematol 2006; 85(9):559-565 Indian J Hematol Blood Transfus. 2018:1-2.
Total Iron requirement in Pregnancy
Total iron requirement during singleton pregnancy: 1000 to 1200 mg.
• The average daily requirement of
iron
• 0.8 mg/d in the first trimester
• 4mg /Day in 2nd trimester
• 6mg/day in 3rd trimester and
increases to even 7.5 mg/day in late
third trimester.
• The average daily absorption from:
Western diet 1–5 mg/day
Indian diet 0.8 - 2 mg/day
8. Nutritional Deficiencies • Iron, Folic acid, Vitamin B12, Copper, Riboflavin
Hemolysis and abnormal
hemoglobin synthesis
• Thalassemia, Sickle cell anemia
• Malaria
• G6PD deficiency
Blood loss, and defective iron
absorption and metabolism
• Helminthiasis, especially hookworm infestation
• Amoebiasis, Giardiasis, Schistosomiasis
• Bleeding haemorrhoids
• Antepartum haemorrhage
Chronic conditions
• Malignancies, Tuberculosis
• Chronic renal disease including urinary tract infection
• Human Immune deficiency Virus infection
• Chronic rheumatic and rheumatoid disease
Best Practice & Research Clinical Obstetrics and Gynaecology 26 (2012) 3–24
Causes of Anemia in Pregnancy
9. Indian J Hematol Blood Transfus. 2018:1-2.
Consequences of IDA in Pregnancy
Maternal anemia contributes to 18% of perinatal mortality and 20% of maternal mortality in
South Asian countries including India
Antepartum complications
• Increased risk of
preterm delivery
• Premature rupture of
membranes
• Pre-eclampsia
• Intrauterine Death
• Inter-current infection
• Antepartum
haemorrhage
• Congestive Heart Failure
Fetal outcomes
• Low birth weight
• Prematurity
• Infections
• Congenital
malformation
• Neonatal Anemia
• Abnormal cognitive
development
• Increased risk of
schizophrenia
Intrapartum complications
• Prolonged labour
• Operative delivery
• Fetal distress
• Abruption
Postpartum complication
• PPH
• Puerperal sepsis
• Lactation failure
• Pulmonary thromboembolism
• Subinvolution of uterus
• Post partum depression
10. Approach to Anemia
MCV <80 MCV 80-100 MCV >100
Microcytic anemia
Serum Iron studies
Ferritin <30
Iron
deficiency
Anemia
Low/normal
iron and
Ferritin with
low TIBS
Suggests a
Component of
Anemia of
Chronic ds
With IDA
Normocytic anemia
Reticulocyte count
Reticulocyte
count <2%
Megloblastic Anemia
Reticulocyte
Count>2%
Mentzer Index
(MCV/RBC)<13
Thalassemia
• Leukemia
• Aplastic anemia
• Pure red cell
aplasia
• Other marrow
failure
• Hemorrhage
• Hemolytic
anemia
Megalocytes& segmented
Neutrophils on PBF
Present
megaloblastic
Absent
Non megaloblastic
• Vitamin B12
• Folate
deficiency
• Drug induced
• Alcohol
• Myelodysplastic
Syndrome
• Liver disease
• Congenital
Bone marrow
failure
11. Indian J Hematol Blood Transfus. 2018:1-2.
Diagnosis of IDA in Pregnancy: Importance of Serum Ferritin
• Sr. Ferritin: <30 µg/dl to diagnose and treat ID in pregnancy
• Indications of testing serum ferritin in pregnancy:
• Prior to starting iron therapy in patients with known hemoglobinopathy
• Differential diagnoses of microcytic anemia is under evaluation (chronic inflammation,
lead toxicity, sideroblastic anemia)
• Suboptimal response to oral iron
• In non-anemic women at risk of iron depletion: Previous anemia, multiple pregnancy,
teenage pregnancy, pregnancy with high risk of bleeding, consecutive pregnancies
• Preferably prior to parenteral iron therapy to confirm iron deficiency
12. Normal Carrier
Red Blood cell index Male Female Beta Thal Minor
Mean corpuscular volume
( MCV fl )
89.1+ - 5.01 87.6 +- 5.5 < 80
Mean corpuscular
Haemoglobin
(MCH pg )
30.9+-1.9 30.2+-2.1 <27
Haemoglobin
( Hb g/dl )
12-16gm 11.5-15gm Male – 11.5-15.3 gm
Female 9.1-14gm
Anemia is not a criteria to diagnose Thalassemia
13. Prevention of Iron Deficiency Anemia
• Iron rich food and avoid substances which interfere with iron absorption
• Food fortification with iron ( wheat flour ( salt )
• Screening of adolescent girls and supplementation of Iron wherever is required
• Cooking in Iron utensils
• Hookworm and malaria chemoprophylaxis
• Adequate birth spacing
14. Iron Prophylaxis
During
Pregnancy
Postpartum
Prophylaxis Treatment
WHO Daily 60mg of iron + 400ug
Of folic acid till term
Daily 120mg of iron and
400ug of folic acid till term
Daily 60mg of iron + 400ug
Of folicx 3 months
MoHFW
Daily 100mg of iron +
500ug folic acid for 100
days
Starting after first
trimester at 14-16 weeks
of gestation
• Mild anemia – 2 IFA /day x
100 days
• Moderate anemia –
Parentral iron + oral folic
acid
Daily 100mg of iron + 500ug
folic acidx 6 months
15. Oral Iron Preparation
Preparation Total iron
(mg/tab
Elemental iron
(mg/tab)
% elemental Iron
Ferrous fumarate 200 66 33 High tolerance
bioavaiability
Ferrous sulphate hydrous
Ferrous Sulphate Dessicated
300
200
60
65
20
32
Most common
Least expensive
Ferrous succinate 100 35 35
Ferrous ammonium citrate 160 30 18
Ferrous Ascorbate 730 100 14 Superior
High elemental iron
Sodium Ferederate 231 33 14
Carbonyl Iron 100 98 98
16. Response to Oral Iron therapy
5-7 days Reticulocyte count increases ( O.2%/day
2 – 3 weeks Hb increases by 0.8 – 1gm/dl/week
All parameters MCV , MCH , MCHC improve
6-8 weeks Hb – normal range
Serum Ferritin Increases
PBF – normocytic normochromic
Clinical Improvement Optimal response > 2g in 2 weeks
19. Indian J Hematol Blood Transfus. 2018:1-2.
Indicators of Parenteral Iron Therapy
IV iron therapy is superior to oral iron in terms of speed and absolute extent of
rise in hemoglobin and replenishment of iron stores
Indications
• Failure of oral iron therapy
• Non-compliance or intolerance to oral iron
• Late second or third trimester with moderate to
severe IDA
• Rapid rectification of anemia and repletion of iron
stores expected
• Malabsorption (e.g. Bowel-resection/Celiac disease)
• Bleeding diathesis when hemorrhage is likely to
continue
Contraindications
• Gestation period < 12 weeks
• Lack of facilities for resuscitation
• Known history of anaphylaxis or
reactions to parenteral iron
• Known state of iron overload
Arch Gynecol Obstet. 2017 Dec;296(6):1229-1234
21. Iron Dextran
Risk of anaphylaxis
Iron Sucrose
Multiple doses; longer time
of administration
Ferric Carboxymaltose
High amount of iron in single
dose with low risk of
hypersensitivity reactions
Iron Isomaltoside
Contains reduced dextran,
more labile iron v/s FCM,
Low clinical evidence
Parenteral
iron
Selecting Ideal Parenteral Iron
22. Property Ideal Iron dextran Iron sucrose Ferric carboxymaltose
Type I (robust) I (robust) II (semi-robust) I (robust)
Mol wt >100 kD >100 kD 34-60 kD 150 kD
Complex stability High High Moderate High
Half life Long 3-4 days 6 hours 16 hours
pH Neutral Neutral High Near-Neutral
Osmolality Isotonic Isotonic High Isotonic
Antigenicity Low High Low Low
Test dose No Yes No No
Time for injection Short 4 - 6 h for 20mg/kg 3.5 h for 7mg/kg 15 min for 1000mg
Max dose High 20mg/kg 600 mg/week 1000 mg/infusion
Arzneimittelforschung 2010;60(6a):345–353; Arzneimittelforschung 2010;60(6a):399–412
Properties of an Ideal Parenteral Iron
23. Critical Attributes of FCM
Type 1 (robust)
Parenteral iron
Not associated with
dextran-induced
hypersensitivity
Can be administered
in much higher doses
Short infusion time
(minimum 15
minutes)
Iron is released slowly,
avoiding toxicity and
oxidative stress
Structure similar to
ferritin, deposited
easily in RE cells
Test dose is not
required
Low immunogenic
potential
Qualities of FCM are best suited for
real-life clinical usage
24. FCM – Dosage Calculation and Administration
In most of Indian pregnant
women 1000 to 1500 mg is
well suited
Ferric carboxymaltose summary of Product Characteristics. Available from: https://www.medicines.org.uk/emc/product/5910/smpc/print
25. Administration of FCM in Routine Clinical Practice
Dilution Duration
Ferric carboxymaltose summary of Product Characteristics. Available from: https://www.medicines.org.uk/emc/product/5910/smpc/print
• Mix Inj FCM 1000mg in 250 ml of saline and give
over 15 minutes
• Mix inj FCM 500mg in 100ml of saline and give
over 6 minutes
• Monitor Vitals for 45 minutes
27. Global Evidence of FCM in Pregnancy
Geography
Total no. of
studies
Countries
No. of pregnant
women treated
with FCM
Highest Hb rise
(g/dL)
Highest Ferritin
rise (µg/L)
Global Studies Ten (#10) Switzerland,
United Kingdom,
Australia, Spain,
Korea, Australia,
UAE, Turkey
2495 3.6 188
Indian Studies Seventeen (#17) India 1326 5.5 180
Current evidence highlighted data of FCM usage in 3821 pregnant women with
maximum Hb rise of 5.5 g/dL and ferritin rise of 180 µg/L
Naqash A et al. BMC Womens Health. 2018; 18(1):6 Jose et al. BMC Pregnancy and Childbirth (2019) 19:54
28. Important Clinical Studies of FCM in Pregnancy
Sr.
no.
Study
Patient
population
In FCM
group
Follow Up
(Weeks)
Hb rise (g/dL)
Ferritin rise
(µg/L)
Any Serious
Adverse Event
1 Maheshwari et al 100 4 3.6 47 No
2 Mishra et al 108 3 2.1 168 No
3 Naqash et al 100 4 5.5 31 No
4 Agrawal et al 50 3 3 65 No
5 Gandotra et al 100 2 2.9 65 No
6 Mahaur et al 50 6 2.6 112 No
7 Patel et al 50 3 2.6 101 No
1. Maheshwari et al. Indian J Obstet Gynecol Res. 2017;4(1):96-100.
2. Mishra V et al. Journal of Nepal Health Research Council. 2017 Sep 8;15(2):96-9
3. Naqash A et al. BMC Womens Health. 2018; 18(1):6
4. Agrawal D et al. J Reprod Contracept Obstet Gynecol. 2019 Jun;8(6):2280-2285
5. Gandotra N et al. Int J Res Med Sci. 2020 Oct;8(10):3539-3542
6. Mahaur et al. International Journal of Clinical Obstetrics and Gynaecology 2020; 4(3):
148-152
7. Patel A et al. Int J Reprod Contracept Obstet Gynecol. 2020 Jun;9(6):2437-2441
29. Inclusion Criteria Intervention Parameters
RCT
100 Pregnant women
diagnosed with moderate to
severe IDA
FCM (n=50): Dose as per
calculated iron requirement
Iron Sucrose (ISC) (n=50):
Dose as per calculated iron
requirement
Rise in Hb from baseline after
12 weeks
Jose et al. BMC Pregnancy and Childbirth (2019) 19:54
Indian RCT from AIIMS, New Delhi
30. Rise in hemoglobin at 12 weeks from baseline
Jose et al. BMC Pregnancy and Childbirth (2019) 19:54
• Treatment with FCM resulted in rapid replenishment of iron stores with significantly
higher Hb rise over a 12 week period.
• Convenient dosing with lesser number of total doses to complete the treatment will
lead to better compliance
Indian RCT from AIIMS, New Delhi: Results
The mean rise in Hb at 12 weeks
was significantly higher in FCM
group than Iron Sucrose group
(29 g/L vs 22 g/L; p < 0.001)
31. Insights from Indian Real World Evidence
50 pregnant women in 2nd and 3rd trimester received a single IV infusion of FCM 1000 mg over 15 minutes
Significant increase in Hb of 2.24
g/dl over 4 weeks
Significant improvement in fatigue
score at 4 weeks
International Journal of Reproduction, Contraception, Obstetrics and Gynecology. 2021 Dec 1;10(12):4402-7.
32. Insights from Largest Indian Real World Evidence
Indian real world evidence of 271 pregnant women receiving FCM of ~1000 mg
Gupte et al, J Obstet Gynaecol Res. 2021 Oct;47(10):3464-3470.
33. • 271 pregnant women in 2nd and 3rd trimester
of pregnancy received FCM (Mean dose
∼1000 mg)
• Significant increase in Hb was noted in just
20 days!
• Significant increase in Hb of 4.23 g/dL was
noted in Severe Anemia
Gupte et al, J Obstet Gynaecol Res. 2021 Oct;47(10):3464-3470.
Insights from Largest Indian Real World Evidence: Efficacy
Single large dose administration of FCM led to rapid rise of Hb in moderate-to-severe anemia
during pregnancy in a real-life scenario.
34. Insights from Largest Indian Real World Evidence: Safety
• Adverse events reported in just 4% of pregnant women! (Most common – rash
and itching)
• No hypersensitivity reactions observed in any pregnant women
• Continuous monitoring of vitals and oxygen saturation up to 45 min did not
report any negative safety signals
Absence of any hypersensitivity reactions and no negative safety signal in vital
parameters observed during continuous monitoring supports excellent safety
of FCM in moderate-to-severe anemia during pregnancy in a real-life scenario
Gupte et al, J Obstet Gynaecol Res. 2021 Oct;47(10):3464-3470.
35. • Data of 162 newborns born to mothers who had received FCM in
pregnancy was analyzed in terms of:
• Mean gestational age at delivery
• Mean birth weight
• Apgar score
• Stillbirth, perinatal, and early neonatal mortality rates
• Requirement of hospitalization
No adverse effects in terms of perinatal and neonatal outcomes were observed
in newborns of women who received FCM during pregnancy
Insights from Largest Indian Real World Evidence: Neonatal Outcomes
Gupte et al, J Obstet Gynaecol Res. 2021 Oct;47(10):3464-3470.
36. Global Clinical Studies: FCM and Neonatal Outcomes
Christoph et al. Journal of perinatal medicine. 2012 Sep 1;40(5):469-74
• 206 pregnant women: Treated either with
FCM or iron sucrose
• Among women treated with FCM, no signs of
negative effects of the FCM treatment were
detected on the fetus or newborn babies.
• 95 pregnant women: Treated with FCM; 83
women among them received single dose of
FCM 1000mg
• Neonatal outcomes (week of pregnancy at
delivery, Apgar scores, and birth weight) were
NOT adversely affected due to FCM
Aporta Rodriguez et al. Obstetrics and gynecology international. 2016 Jan 1;2016
37. Global Clinical Studies: Neonatal Outcomes
Breymann et al. Journal of perinatal medicine. 2017;45(4):443-53
• 126 pregnant women: Treated with FCM
(1000 – 1500 mg)
• No complications associated with FCM
treatment of the mothers were evident in the
newborns
• 83 pregnant women: Treated with FCM (1000
mg single dose)
• FCM administered to pregnant women did
not affect fetal outcomes (Apgar scores,
weight, length or head circumference of the
baby, neonatal resuscitation or
complications)
Khalafallah A et al. InSeminars in hematology. 2018; 55(4):223-234
38. Mild anemia (Hb 10-10.9g/dL) & Moderate anemia ( 7-9.9 g/dL)
First level of treatment
Two tablets of iron and folic acid tablet (100 mg elemental
iron and 500 mcg folic acid) daily for 6 months
Parental iron (IV Iron Sucrose or FCM) may be considered as
the first line of management in pregnant women who are
detected to be anemic late in pregnancy or in whom
compliance is likely to be low (high chance of lost to follow-
up).
If no improvement,
after first level of
treatment
• Referral to higher health facility
• The case may be managed with IV Iron Sucrose/Ferric
Carboxymaltose
Anemia Mukt Bharat Guidelines 2018
Anemia management protocol for Pregnant women
39. Severe anemia (Hb 5-6.9 g/dL)
First level of
treatment
Immediate hospitalization if it is the third
trimester of pregnancy where round-the-clock
specialist care is available
The treatment will be done using IV Iron
Sucrose/Ferric Carboxymaltose by the medical
officer.
Anemia Mukt Bharat Guidelines 2018
Anemia management protocol for Pregnant women
40. FCM in Management of IDA in Pregnancy: Conclusion
• FCM is superior to oral iron and other IV irons in terms of speed and absolute extent of rise
in hemoglobin and replenishment of iron stores
• FCM administration does not require test dose; not associated with dextran-induced
hypersensitivity; can be administered safely in a higher dose in short duration
• FCM infusion during pregnancy is not associated with severe hypersensitivity reactions and
negative safety signals in vital parameters
• Substantial Global and Indian evidence encompassing 3821 pregnant women with maximum
Hb rise of 5.5 g/dL and ferritin rise of 180 µg/L
• FCM administered to pregnant women for treatment of IDA did not adversely affect
neonatal outcomes (Apgar score, birth weight, mortality rates, hospitalization rates, etc.)
Editor's Notes
FOGSI General Clinical Practice Recommendations.Management of Iron Deficiency Anemia in Pregnancy.India;2017
These requirements are unlikely to be met by the diet alone because of poor accessibility, availability, and affordability of diversified food. Hence, regular iron supplementation is necessary for pregnant women to prevent IDA
Currently available formulations are iron-carbohydrate complexes or colloids based on small spheroidal particles, each consisting of a core of iron surrounded by a carbohydrate shell; the latter stabilizes the molecule and slows the release of elemental iron