| CTRI Number |
CTRI/2024/09/073762 [Registered on: 11/09/2024] Trial Registered Prospectively |
| Last Modified On: |
10/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of inflammation in repeated pregnancy loss |
|
Scientific Title of Study
|
Role of inflammatory markers (serum ferritin, C-reactive protein, interleukin 6) in recurrent pregnancy loss |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shami Aara |
| Designation |
Post graduate resident in obstetrics and gynaecology |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Obstetrics and Gynaecology,
Maulana Azad Medical College,
New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9836116156 |
| Fax |
|
| Email |
shamiaara@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Y M Mala |
| Designation |
Head of the department |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Obstetrics and Gynaecology,
Maulana Azad Medical College,
New Delhi.
New Delhi
DELHI
110002
India |
| Phone |
01123235824 |
| Fax |
|
| Email |
ym_mala@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Shami Aara |
| Designation |
Post graduate resident in obstetrics and gynaecology |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Obstetrics and Gynaecology,
Maulana Azad Medical College,
New Delhi.
New Delhi
DELHI
110002
India |
| Phone |
09836116156 |
| Fax |
|
| Email |
shamiaara@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of obstetrics and gynaecology, Lok Nayak Hospital,Maulana Azad Medical College, New Delhi |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Other [None] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Y M Mala |
Department of Obstetrics and Gynaecology, Maulana Azad Medical College, New Delhi-110002 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shami Aara |
Lok Nayak Hospital |
Department of Obstetrics and Gynaecology, Maulana Azad Medical College
New Delhi
DELHI |
9836116156
shamiaara@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O039||Complete or unspecified spontaneous abortion without complication, |
|
|
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 |
FOR CASES: Pregnant women with two consecutive miscarriages.
FOR CONTROLS: Pregnant women without history of any miscarriage and with period of gestation and body mass index matched to that of study group |
|
| ExclusionCriteria |
| Details |
Pregnant woman with-
1.Known uterine anomalies
2.Chronic inflammatory diseases
3.Any acute illness in last 3 months
HIV, Hepatitis B, Hepatitis C, VDRL infections
4.Any intramuscular injection in last 3 weeks
5.Steroids or immunomodulator therapy
6.Moderate to severe anemia
7.Diabetes and thyroid dysfunction
8.Diagnosed autoimmune disorders
9.Toxoplasmosis
10.Diagnosed fetal anomalies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Association of inflammatory markers with recurrent pregnancy loss
|
1yr
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Difference in the level of inflammatory markers between women with recurrent pregnancy loss & normal pregnant women
|
1yr |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
21/09/2024 |
| 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
|
This is a case-control study and will be conducted on patients attending the antenatal OPD/IPD/casualty at Lok Nayak Hospital for a period of one year. A total number of 100 patients will be recruited in the study. Out of which 50 patients will be cases (with history of two pregnancy losses), 50 women with normal pregnancy and no history of miscarriages with matched period of gestation & BMI will be taken as controls. A written informed consent to participate in the study will be taken from both cases and controls. A predesigned structured proforma will be used to record the information about patient’s demography, socioeconomic status and complete obstetric history including previous antenatal records if present. All the patients will undergo clinical examination and routine laboratory tests. 3 ml of venous blood sample will be taken in plain vial from both study and control groups to assess the levels of serum ferritin, CRP and IL6 levels. Patients will be managed as per the hospital protocols. |