Efficacy and Saftey of Intravenous Versus Oral Iron Therapy in Postpartum Anemia - A Randomised Controlled Trial

Phase 4

Not yet recruiting

Conditions: Postpartum females whos hemoglobin value 36-48 hour after delivery falls between 8-10 mg/dl

Registration Number: CTRI/2020/02/023125

Lead Sponsor: Department of Obstetrics And Gynecology

Brief Summary: Postpartum anemia is a common problem throughout the world. Prevalance of anemia in Indian mother is 80-90%. 50% of pregnant woman is affected by anemia globally. There are many treatment options for iron deficiency anemia ; Oral iron therapy is most commonly used, but due to its side effects and patients noncompliance, parenteral iron is also used nowadays.

A single center, open label,randomized , controlled , parallel group phase 4 study will be conducted in women with postpartum anemia in the department of Obstetrics and Gynecology, Rajagiri Hospital,Aluva,Kerala, which is a tertiary care centre .Our aim is to compare the efficacy and saftey of intravenous and oral iron in treatment of iron deficiency anemia during postpartum period. 80 woman with hemoglobin level between 8-10 mg/dl 36-48 hours after delivery will be included in the study. Study popullation will be allocated in to two groups , Group A and Group B by computer based simple randomization .Group A will be treated with intravenous ferric carboxy maltose and Group B will be treated witrh ferrous fumarate 152mg twice daily for 6 weeks. side effects will be monitored, hemoglobin level estimated 2 weeks and 6 weeks after delivery. The outcome of the two groups will be compared, statistically analysed and documented.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 80

Inclusion Criteria

Patients with Hemoglobin between 8-10gm/dl, 36-48 hours after delivery.
Group A will be treated with Intravenous Iron .
Group B will be treated with Tablet Iron.

Exclusion Criteria

Peripartum Blood Transfusion Intolerance To Iron Derivatives Clotting disorders Patients with Anemia other than that caused by blood loss secondary to delivery and iron deficiency anemia.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To identify the efficacy of Intravenous Iron therapy compared with Oral Iron for treating Postpartum anemia	36-48 Hours after delivery \| 2 Weeks and 6 Weeks Postpartum period

Secondary Outcome Measures

Name	Time	Method
To find out if there are adverse drug reaction to Intravenous Ferric carboxy maltose as treatment for Postpartum anemia	To find out the acceptability of intravenous iron ( ferric carboxy maltose) therapy for postpartum anemia

Trial Locations

Locations (1): Department of Obstetrics And Gynecology
🇮🇳
Ernakulam, KERALA, India
Department of Obstetrics And Gynecology
🇮🇳Ernakulam, KERALA, India
Dr V P PAILY
Principal investigator
9447633707
vppaily@gmail.com