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CTRI Number  CTRI/2025/04/085021 [Registered on: 17/04/2025] Trial Registered Prospectively
Last Modified On: 04/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Severe and very severe anaemia in pregnancy and its impact on mother and baby in last trimester of pregnancy 
Scientific Title of Study   Severe and very severe anaemia in pregnancy and fetomaternal outcome in third trimester: An Observational study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Wadaskar Apeksha Satish 
Designation  Junior Resident 
Affiliation  Rohilkhand Medical College and Hospital, Bareilly 
Address  Room no 2028, Department of Obstetrics and Gynaecology, Rohilkhand Medical College and Hospital,Pilibhit Bypass Road, Bareilly, Uttar Pradesh, India

Bareilly
UTTAR PRADESH
243006
India 
Phone  8104435675  
Fax    
Email  wadaskarapeksha11@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Wadaskar Apeksha Satish 
Designation  Junior Resident 
Affiliation  Rohilkhand Medical College and Hospital, Bareilly 
Address  Room no 2028, Department of Obstetrics and Gynaecology, Rohilkhand Medical College and Hospital,Pilibhit Bypass Road, Bareilly, Uttar Pradesh, India

Bareilly
UTTAR PRADESH
243006
India 
Phone  8104435675  
Fax    
Email  wadaskarapeksha11@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rashmi Prasad 
Designation  Associate Professor 
Affiliation  Rohilkhand Medical College and Hospital, Bareilly 
Address  Room no. 2028, Department of Obstetrics and Gynaecology, Rohilkhand Medical College and Hospital, Bareilly, Uttar Pradesh, India

Bareilly
UTTAR PRADESH
243006
India 
Phone  9321089998  
Fax    
Email  drrashmiprasad@gmail.com  
 
Source of Monetary or Material Support  
Rohilkhand Medical College and Hospital, Bareilly, Uttar Pradesh, India 243006 
 
Primary Sponsor  
Name  Rohilkhand Medical College and Hospital, Bareilly 
Address  Rohilkhand Medical College and Hospital, Pilibhit Bypass Road, Bareilly, Uttar Pradesh, India 243006 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Apeksha Wadaskar   Rohilkhand Medical College and Hospital, Bareilly  Department of Obstetrics and Gynaecology, Rohilkhand Medical College and Hospital, Bareilly, Uttar Pradesh, India 243006
Bareilly
UTTAR PRADESH 
8104435675

wadaskarapeksha11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, RMCH, Bareilly, UP  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O990||Anemia complicating pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Pregnant females with hemoglobin less than or equal to 7 g/dl and gestational age more than or equal to 28 weeks 
 
ExclusionCriteria 
Details  - Bleeding placenta previa
- Bleeding due to non obstructive causes like haemorrhoids. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
•To correlate the signs and symptoms of severe and very severe anaemia with laboratory findings.
•To detect the morphological and etiological types of severe and very severe anaemia in pregnant women.


 
Outcome will be assessed during anc visit , 1 week after intervention (if any) , during labour and one week postpartum

 
 
Secondary Outcome  
Outcome  TimePoints 
To assess maternal outcome in terms of maternal morbidity and mortality.
To assess fetal outcome in terms of APGAR score, low birth weight, IUGR and IUD. 
Outcome will be assessed during Intrapartum period and 1 week postpartum. 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
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)   30/04/2025 
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  

Pregnancy-related anaemia is a serious public health issue all over the world, but it is especially problematic in developing nations like India .WHO’s most recent study states that the prevalence of anaemia among females aged 15-49 who are pregnant and those who are not rose between 2012 & 2016 in majority of countries. One of the main variables affecting both the newborn’s health and the morbidity and mortality of the mother is anaemia. It is a worldwide health concern that over half of expectant mothers experience.

World health organization defines anaemia as haemoglobin less than 11gm/dl in first and third trimester and less than 10.5 gm/dl in second trimester. Anaemia is divided into three categories according to haemoglobin level: mild (9.1 to 11gm%), moderate (7.1 to 9 gm%), severe (4.1-7 gm%)[2], very severe ( <4 gm%).

Physiological anaemia is a common ailment during pregnancy. Erythroid hyperplasia of the marrow occurs during pregnancy and in a singleton pregnancy, the mass of RBCs increase by 15-20%. However 40-50% increase in plasma volume causes hemodilution also known as “pregnancy associated hydremia” which raises the need for iron. An average haematocrit drops from 38-45% in healthy non pregnant women to roughly 34% in singleton pregnancy and to 30% in multifetal pregnancy, indicating physiological anaemia. Throughout pregnancy oxygen carrying capacity is normal despite hemodilution. Due to fetal and placental growth and larger amount of circulatory blood there is increased demand for nutrients, especially iron and folic acid as their stores are already low. There are numerous causes of pathological anaemia in pregnancy. Mild anaemia is mostly due to nutritional deficiency i.e., dietary deficiency of iron, folic acid and vitamin B12 and presence of inhibitors of iron absorption. Moderate anaemia is due to hemoglobinopathies like Beta Thalassemia minor, Sickle cell trait, nutritional deficiency. Severe anaemia in pregnancy can occur due to infections (like Malaria, hook work infestation), chronic diseases like chronic kidney disease, heart failure, autoimmune diseases like Rheumatoid arthritis, vasculitis, Crohn’s disease and Ulcerative colitis. In patients with chronic blood loss, Beta Thalassemia major, Sickle cell disease also presents with severe anaemia. Due to recent advancement in medical sciences, and improvement in management of these haemoglobinopathies these patients can now experience uneventful pregnancy.

 The majority of the severely anaemic women belong to low socioeconomic status who are uneducated and are un booked pregnancies who have not taken iron and folic acid supplementation during pregnancy. Other risk factors include multiple pregnancies, teenage pregnancy, iron deficiency, lack of appropriate spacing between pregnancies, parasitic infestation (e.g. malaria, hookworm infestation), poor environmental and personal hygiene.

 Severe anaemia in pregnancy have adverse outcomes in mother and fetus leading to maternal and fetal morbidity and mortality. It is associated with multiple spontaneous abortions, pre-term labour, pre-eclampsia, recurrent infections, antepartum haemorrhage and postpartum haemorrhage in mother. It is important to timely diagnose the cause and to treat it to prevent the adverse effects on fetus such as intrauterine growth restriction, intrauterine fetal death, birth asphyxia, low birth weight babies.

 Anaemia being an important concern during pregnancy, the current study is aimed to find out various risk factors, causes , different pathological findings and management of severe anaemia. Inspite of all the Government policies implemented to decrease anaemia in pregnancy, the problem is still very much prevalent. At our region, it has been noticed that the number of patient affected by severe and very severe anaemia are more. Also the number of studies on severe anaemia and very severe anaemia are less, hence the need of study.

 
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