| CTRI Number |
CTRI/2020/02/023125 [Registered on: 05/02/2020] Trial Registered Prospectively |
| Last Modified On: |
31/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy and Saftey of Intravenous Versus Oral Iron Therapy in Postpartum Anemia - A Randomised Controlled Trial |
|
Scientific Title of Study
|
Efficacy, Safety and Acceptability of Intravenous Versus Oral Iron Therapy in Postpartum Anemia - A Randomised Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajitha Kumari Sudhamma |
| Designation |
Senior Consultant |
| Affiliation |
rajagiri hospital |
| Address |
Department Of Obstetrics And Gynecology
Rajagiri Hospital
Chunangamvely
Aluva, Ernakulam
Ernakulam
KERALA
683112
India |
| Phone |
9447185392 |
| Fax |
|
| Email |
ajithasudhamma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VPPaily |
| Designation |
Head Of The Department |
| Affiliation |
rajagirihospital |
| Address |
Department OF Obstetrics And Gynecology
Rajagiri Hospital
Chunangamvely
Aluva, Ernakulam
Ernakulam
KERALA
683112
India |
| Phone |
9447633707 |
| Fax |
|
| Email |
vppaily@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VPPaily |
| Designation |
Head Of The Department |
| Affiliation |
rajagirihospital |
| Address |
Department OF Obstetrics And Gynecology
Rajagiri Hospital
Chunangamvely
Aluva, Ernakulam
Ernakulam
KERALA
683112
India |
| Phone |
9447633707 |
| Fax |
|
| Email |
vppaily@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department OF Obstetrics And Gynecology
Rajagiri Hospital
Chunangamvely
Aluva, Ernakulam |
|
|
Primary Sponsor
|
| Name |
Department of Obstetrics And Gynecology |
| Address |
Department Of Obstetrics And Gynecology
Rajagiri Hospital
Chunangamvely
Aluva, Ernakulam
pin 683112 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr V P PAILY |
Department of Obstetrics And Gynecology |
Department Of Obstetrics And Gynecology
Rajagiri Hospital
Chunangamvely
Aluva, Ernakulam
Ernakulam
KERALA |
9447633707
vppaily@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajagiri hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Postpartum females whos hemoglobin value 36-48 hour after delivery falls between 8-10 mg/dl |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous Iron And Oral Iron |
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. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
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 |
36-48 Hours after delivery
2 Weeks and 6 Weeks Postpartum period |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/02/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |