| CTRI Number |
CTRI/2021/07/035271 [Registered on: 29/07/2021] Trial Registered Prospectively |
| Last Modified On: |
27/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Daily vs alternate oral iron therapy in pregnant women in iron deficiency anaemia |
|
Scientific Title of Study
|
Daily versus intermittent oral iron therapy in pregnant women with iron deficiency anaemia: A single centre, open label, non-randomized control trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyotsna Pathak |
| Designation |
Assistant Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences,Patna,Bihar,India |
| Address |
Deptt. of OBGYN,IGIMS,Sheikhpura,Patna,Bihar
Deptt. of OBGYN,IGIMS,Sheikhpura,Patna,Bihar
Patna
BIHAR
800014
India |
| Phone |
7004128759 |
| Fax |
|
| Email |
jyotsnapathak2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jyotsna Pathak |
| Designation |
Assistant Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences,Patna,Bihar,India |
| Address |
Deptt. of OBGYN,IGIMS,Sheikhpura,Patna,Bihar
Deptt. of OBGYN,IGIMS,Sheikhpura,Patna,Bihar
Patna
BIHAR
800014
India |
| Phone |
7004128759 |
| Fax |
|
| Email |
jyotsnapathak2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jyotsna Pathak |
| Designation |
Assistant Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences,Patna,Bihar,India |
| Address |
Deptt. of OBGYN,IGIMS,Sheikhpura,Patna,Bihar
Deptt. of OBGYN,IGIMS,Sheikhpura,Patna,Bihar
Patna
BIHAR
800014
India |
| Phone |
7004128759 |
| Fax |
|
| Email |
jyotsnapathak2010@gmail.com |
|
|
Source of Monetary or Material Support
|
| None,Govt Medical College |
|
|
Primary Sponsor
|
| Name |
Government Medical College |
| Address |
Department of OBGYN,Indira Gandhi Institute of Medical Sciences,Sheikhpura,Patna-14 |
| Type of Sponsor |
Government medical college |
|
|
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 Jyotsna Pathak |
Indira Gandhi Institute of Medical Sciences |
Department of OBGYN,Indira Gandhi Institute of Medical Sciences,Sheikhpura,Patna-14
Patna
BIHAR |
7004128759
jyotsnapathak2010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee-IGIMS,Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O280||Abnormal hematological finding onantenatal screening of mother, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1-(twice daily arm) |
Tablet ferrous fumarate 1 tablet containing 50 mg elemental iron twice-daily per oral in empty stomach will be given as standard therapy for 6 weeks |
| Comparator Agent |
Group 2-(alternate day arm) |
Tablet ferrous fumarate 2 tablets each containing 50mg of elemental iron per oral in empty stomach on alternate days will be given for 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women with haemoglobin concentration less than 11 g/dL and haematocrit less than 33% with singleton pregnancy between 16-28 weeks of gestation, irrespective of parity will be taken |
|
| ExclusionCriteria |
| Details |
• Multiple pregnancy
• underweight (BMI < 18.5 kg/m2) or obese(>30kg/m2)
• Severe anemia with maternal hemoglobin levels less than 7 g/dL
• Hypertensive disorders of pregnancy
• Diabetes mellitus (gestational /overt ) not controlled on diet
• Anaemia of chronic disease
• History of gastrointestinal bleeding
• Haemoglobinopathies
• Megaloblastic anaemia
• HIV, HBsAg, HCV, Covid-19 positive
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
response to therapy
Following blood tests will be done as baseline ,3-week ,6 week interval
• Complete blood count
• Total iron study
|
response to therapy
Following blood tests will be done as baseline ,3-week ,6 week interval
• Complete blood count
• Total iron study
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Side effects,compliance |
3 week,6 week |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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 2 |
|
Date of First Enrollment (India)
|
02/08/2021 |
| 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="1"
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)?
Response - NO
|
|
Brief Summary
|
Daily versus alternate day therapy of oral iron in the treatment of iron deficiency anaemia is done to see and comp[are the efficacy , compliance and side effects . It may have implications in the treatment of iron deficiency of iron deficiency anaemia in pregnancy |