| 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
|
|
|
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
|
|
|
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%),
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. |