Iron deficiency anaemia in pregnancy
Conditions
Interventions
1. Settings
Obstetric unit of Dr. M Dissanayake at Teaching hospital, Kalutara
Professorial Obstetric unit at Teaching hospital, Peradeniya
Professorial Obstetric unit at Teaching hospital, Batticaloa
Sponsors
Zydus Lifesciences Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pregnant female (gestational age 14 to 24 weeks). 2. Aged 18 years and above. 3. Hemoglobin levels 7 g/dl and serum ferritin < 30 µg/dl. 4. A diagnosis of iron deficiency anaemia based on the blood picture.
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to iron supplements 2. Reported intolerance to iron supplements in the past 3. Severe anemia requiring parentral transfusion or transfusion of blood products 4. Known diagnosis of anemia related to causes other than iron deficiency (thalassemia, chronic disease, sickle cell, sideroblastic anaemia etc.) 5. Hemochromatosis or iron overload 6. Malabsorptive, ulcerative or inflammatory gastro-intestinal disease 7. History of serious progressive or chronic inflammatory disease (cardiac, renal, hepatic, oncological, autoimmune or any other systemic disease) 8. Undergone surgery in one month before enrolment or planned to undergo surgery during the course of study 9. Subject simultaneously participating in any other clinical studies or having participated in any other clinical trial in the past 3 months. OR 10. History or other evidence of severe illness or any other conditions that would make the patient, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease, bariatric or bowel surgery, HIV infection, or severe coronary artery disease).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of women who achieve a Hb>11 g/dl. [Baseline and every 4 weeks till end point or Hb at admission for delivery] The duration of therapy required to achieve a Hb =11 g/dl in each group. [Baseline and every 4 weeks till end point or Hb at admission for delivery] | — |
Secondary
| Measure | Time frame |
|---|---|
| The mean serum ferritin levels in each group [At recruitment and when primary endpoint of Hb>11g/L is reached or at delivery] The change (end point – starting point) in serum ferritin levels among the three groups [At recruitment and when primary endpoint of Hb>11g/L is reached or at delivery] The change (end point – starting point) in Hb levels among the three groups [ At recruitment and when primary endpoint of Hb>11g/L is reached or at delivery] The change (end point – starting point) in serum ferritin levels among the three groups [At recruitment and when primary endpoint of Hb>11g/L is reached or at delivery] A subgroup analysis for groups; Hb 7-9 g/dl and 9-11 g/dl analysing the change in Hb and serum ferritin levels. [ At recruitment and when primary endpoint of Hb>11g/L is reached or at delivery] GI tolerability (Frequency of GI adverse events - Nausea, Vomiting, GI irritation, Diarrhea, Constipation, Abdominal Pain) • Birth weight • Adverse events reported during the study will be captured in Council for International Organizations of Medical Sciences (CIOMS) format12 [Every 4 weeks ] Birth weight [ Delivery] Adverse events reported during the study will be captured in Council for International Organizations of Medical Sciences (CIOMS) format12. [Every 4 weeks] | — |
Countries
Sri Lanka
Contacts
Public ContactDr. CD Ekanayake
Senior Lecturer
Outcome results
None listed