| CTRI Number |
CTRI/2025/06/088855 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
13/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Anemia During Pregnancy and Its Effects on Mothers and Babies: A One-Year Study |
|
Scientific Title of Study
|
ANAEMIA IN PREGNANCY AND ITS MATERNAL AND PERINATAL OUTCOMES
A ONE YEAR CROSS-SECTIONAL STUDY |
| Trial Acronym |
Effects of Anaemia in pregnancy on mother and baby |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mouna Ravi |
| Designation |
MS post graduate |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, NEHRU NAGAR BELAGAVI
Belgaum
KARNATAKA
590010
India |
| Phone |
9100335325 |
| Fax |
|
| Email |
mounaravi98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M C Metgud |
| Designation |
Professor |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY,NEHRU NAGAR BELAGAVI
Belgaum
KARNATAKA
590010
India |
| Phone |
9164693333 |
| Fax |
|
| Email |
metm@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M C Metgud |
| Designation |
Professor |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, NEHRU NAGAR BELAGAVI
Belgaum
KARNATAKA
590010
India |
| Phone |
9164693333 |
| Fax |
|
| Email |
metm@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi |
|
|
Primary Sponsor
|
| Name |
Dr Mouna Ravi |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, JAWAHARLAL NEHRU MEDICAL COLLEGE, BELAGAVI, KARNATAKA- 590010 |
| 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 |
| Dr Mouna Ravi |
KAHERs Dr. Prabhakar Kore Hospital and Medical Research Centre |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, OPD NO 10, KAHERs Dr. Prabhakar Kore hospital and Medical Research Centre, Nehru nagar, BELAGAVI, Belgaum
KARNATAKA- 590010
Belgaum
KARNATAKA |
9100335325
mounaravi98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O268||Other specified pregnancy relatedconditions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.All pregnant anaemic women in the labour rooms of KAHER;s Dr. Prabhkar Kore Hospital and Medical Research Centre, Belagavi
2. Singleton pregnancy |
|
| ExclusionCriteria |
| Details |
1. Multiple gestation
2. Patients with chronic anaemias like sickle cell disease, thalassemia, or any immunological disorders
3.Patients with chronic disorders like chronic hypertension, overt diabetes, renal disorders, cardiac disorders
4. Previous baby with genetic disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the maternal outcomes associated with anaemia in pregnancy |
During pregnancy, at delivery and postpartum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the perinatal outcomes associated with anaemia in pregnancy |
Peripartum & postpartum |
|
|
Target Sample Size
|
Total Sample Size="251"
Sample Size from India="251"
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)
|
24/06/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The demand for iron for both mother and the fetus considerably increases during pregnancy. Normally pregnancy is associated with significant drop in haemoglobin levels due to plasma volume expansion. Therefore, maternal anaemia is one of the most common disorders in pregnancy and it can cause various adverse maternal and perinatal outcomes. So early detection and treatment of anaemia in pregnancy can lead to decrease in various maternal and perinatal outcomes associated with it.
This study aims at seeing various maternal and perinatal outcomes associated with anaemia in pregnancy and preventing them by regular antenatal checkups and timely interventions.
It is a cross- sectional observational study for all the pregnant women delivering in KAHER’s Dr.Prabhakar Kore Hospital and Medical Research Center, Belagavi for a study period of one year. It does not require randomisation and followup. |