| CTRI Number |
CTRI/2023/02/049588 [Registered on: 09/02/2023] Trial Registered Prospectively |
| Last Modified On: |
26/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A study of women developing anaemia after delivery and measures used to correct deficiency |
|
Scientific Title of Study
|
A Prospective study of Postpartum Anaemia- incidence and interventions |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shaik Rifaat Sultana |
| Designation |
Post Graduate |
| Affiliation |
Jawaharlal Nehru Medical College, KLE |
| Address |
Department of Obstetrics and Gynaecology, JNMC college building, Floor-2, Jawaharlal Nehru Medical College, KLE Dr. Prabhakar Kore Hospital, Shivabasvanagar Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9618798170 |
| Fax |
|
| Email |
rifaatshaik16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MC Metgud |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College, KLE |
| Address |
Department of Obstetrics and Gynaecology, JNMC college building, Floor-2, Jawaharlal Nehru Medical College, KLE Dr. Prabhakar Kore Hospital, Shivabasvanagar Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9618798170 |
| Fax |
|
| Email |
Metm67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MC Metgud |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College, KLE |
| Address |
Department of Obstetrics and Gynaecology, JNMC college building, Floor-2, Jawaharlal Nehru Medical College, KLE Dr. Prabhakar Kore Hospital, Shivabasvanagar Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9618798170 |
| Fax |
|
| Email |
Metm67@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Obstetrics and Gynaecology,Jawaharlal Nehru Medical College, KLE Dr. Prabhakar Kore Hospital, Shivabasvanagar Belagavi, Karnataka |
|
|
Primary Sponsor
|
| Name |
Shaik Rifaat Sultana |
| Address |
Department of Obstetrics and Gynaecology, Jawaharlal Nehru Medical College, KLE Dr. Prabhakar Kore Hospital, Shivabasvanagar, Belagavi, Karnataka |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Shaik Rifaat Sultana |
Jawaharlal Nehru Medical College, KLE |
Department of Obstetrics and Gynaecology, JNMC college building, Floor-2, KLE Dr. Prabhakar Kore Hospital, Shivabasvanagar, Belagavi, Karnataka
Belgaum
KARNATAKA |
9618798170
rifaatshaik16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Instituitional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Women more than or equal to 18 years of age
Women undergoing vaginal or caesarean section deliveries at a gestational age of 28 weeks or more |
|
| ExclusionCriteria |
| Details |
Women less than 18 years of age
Women with pre eclampsia and eclampsia
Women not willing to give consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the incidence of Postpartum Anaemia |
Follow up needed 3 weeks post delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find out the various interventions done to correct anaemia
To compare the efficacy of different modes of interventions |
3 weeks |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A Prospective Study of Postpartum Anemia- incidence and interventions
Introduction and Need for study-
Postpartum Anaemia is a common problem throughout the world and is highest among developing countries like India and can lead to maternal mortality and morbidity. It is estimated that 20% of maternal deaths are due to peripartum haemorrhage and anaemia. This arises the need for prevention of iron deficiency anaemia during pregnancy and thereby reducing the incidence of postpartum anaemias.
Study Protocol- After taking informed consent of the patient, haemoglobin levels of all pregnant women being admitted to KLES Dr Prabhakar Kore Hospital fulfilling the inclusion criteria will be recorded and compared to their respective haemoglobin levels at 24 hrs post delivery to assess the incidence of postpartum anaemia. The different modes of interventions done to correct anaemia will be monitored and recorded, and their efficacy noted. These patients will be asked to follow up after 3 weeks of treatment to document the improvement in their iron reserves.
|