Trial on oral iron preparation in iron deficiency anaemia in pregnancy
- Conditions
- Health Condition 1: O098- Supervision of other high risk pregnancies
- Registration Number
- CTRI/2019/08/020863
- Lead Sponsor
- il
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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 <7 g% & 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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