Health Condition 1: O098- Supervision of other high risk pregnancies
Conditions
Interventions
Intervention1: ferrous fumarate: Ferrous fumarate (152 mg contains 50 mg elemental iron and 0.75 mg folic acid) to be prescribed 4 times daily
Intervention2: ferrous ascorbate: Ferrous ascorbate (100
Sponsors
Nil
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pregnant women with age between 20 and 40 years and period of gestation from 12 to 30 weeks. 2. Hemoglobin ranging from 7 to 10.5 g% at the start of the study 3. Treatment naïve patients 4. Singleton pregnancy 5. Patients willing to give written informed consent
Exclusion criteria
Exclusion criteria: 1. Pregnant women with any other types of anemia such as megaloblastic anemia, thalassemia, sickle cell anemia, anemia of chronic disease, hemolytic anemia and anemia due to chronic blood loss. 2. Pregnant women with Hb 10.5g% 3. Pregnant women with known hypersensitivity to iron preparations 4. Pregnant women with any other comorbidities such as renal or hepatic impairment, cardiovascular diseases, preeclampsia, GDM, thyroid disorders, acid peptic disease, esophagitis and malabsorption syndrome. 5. Treatment with any other investigational drug in the last 1 month before study entry 6. Multiple pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants becoming non-anemic [Hbâ?¥ 11g%] at the end of the studyTimepoint: Proportion of participants becoming non-anemic [Hbâ?¥ 11g%] at the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in hemoglobin levels based on the weeks of gestationTimepoint: 8 week;cost of individual drug therapyTimepoint: 8 week;incidence of any adverse eventsTimepoint: 8 week;proportion of participants achieving normal iron indices like serum iron, ferritin, TIBC, transferrin saturationTimepoint: 8 week;proportion of participants achieving normal RBC indices like PCV, MCV, MCH, MCHCTimepoint: 8 week | — |
Countries
India
Contacts
Public ContactDr Nanda Gamad
PGIMER
Outcome results
None listed