Clinical trial to determine the efficacy and tolerability of oral iron preparations in iron deficiency aneamia in pregnancy
- Conditions
- Health Condition 1: D50-D89- Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism
- Registration Number
- CTRI/2021/07/035277
- Lead Sponsor
- GC Chemie Pharmie Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 4
Age � 18 years at recruitment.
Pregnant women between 16 and 28 weeks of gestation diagnosed with Iron deficiency Anemia
Haemoglobin between 7 to 9gm%
Treatment New Patients
Singleton Pregnancy
Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures.
Within two months of starting iron therapy.
Multiple pregnancy
History of previous or repeated blood transfusion.
History of haematological disease.
Hemodynamic instability or clinically perceived or anticipated need of blood transfusion
Risk of preterm labour.
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.
Treatment with any other investigational drug in the last 1 month before study entry
Current usage of iron supplement
High risk pregnancy.
Women who are unable to give informed consent. Women who have intolerant to iron derivatives,
Patients suffering from any bleeding disorder like bleeding piles or active peptic ulcer.
Women with antepartum haemorrhage and those who delivered
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method