| CTRI Number |
CTRI/2024/01/061858 [Registered on: 25/01/2024] Trial Registered Prospectively |
| Last Modified On: |
23/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate association of insulin resistance, inflammatory markers in recurrent pregnancy loss- A case control study |
|
Scientific Title of Study
|
Assessment of Insulin Resistance, Inflammatory and Oxidative stress markers in women with 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 |
DR RESHMA NAKKA |
| Designation |
Junior resident obstetrics and gynecology |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Jawaharlal institute of postgraduate medical education and research
Dhanvantri nagar
Pudhucherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8919733069 |
| Fax |
|
| Email |
reshmanakka97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR CHITRA T |
| Designation |
Professor obstetrics and gynecology |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Jawaharlal institute of postgraduate medical education and research
Dhanvantri nagar
Pudhucherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9488818644 |
| Fax |
|
| Email |
drchitra@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR CHITRA T |
| Designation |
Professor obstetrics and gynecology |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Jawaharlal institute of postgraduate medical education and research
Dhanvantri nagar
Pudhucherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9488818644 |
| Fax |
|
| Email |
drchitra@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of postgraduate medical education and research DHANAVANTRINAGAR PONDICHERRY PIN-605006
|
|
|
Primary Sponsor
|
| Name |
INSTITUTE INTRAMURAL FUND |
| Address |
Jawaharlal Institute of postgraduate medical education and research DHANAVANTRINAGAR PONDICHERRY PIN-605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 RESHMA NAKKA |
Jawaharlal institute of postgraduate medical education and research |
Department of obstetrics and gynaecology, Women and children’s hospital, Jawaharlal institute of postgraduate medical education and research, Dhanvanthri nagar
Pondicherry
Pondicherry
PONDICHERRY |
8919733069
reshmanakka97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for observational studies DHR reg.no. EC/NEW/INST/2020/331 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
recurrent pregnancy loss |
| Patients |
(1) ICD-10 Condition: O039||Complete or unspecified spontaneous abortion without complication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
CASE-
1. AGE MORE THAN 18
2. 2 OR MORE THAN 2 RECURRENT PREGNANCY LOSS BEFORE 24 WEEKS
3. NO PREGNANCY BEYOND 24 WEEKS
4. 6 WEEKS POSTPARTUM
CONTROL
1. AGE MORE THAN 18
2. BMI MATCHED
3. ATLEAST 1 LIVING CHILD
4. 6 WEEKS POSTPARTUM |
|
| ExclusionCriteria |
| Details |
FOR CASE AND CONTROL
1. DIABTES
2. PCOS
3. ECTOPIC OR MOLAR PREGNANCY |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO FIND ASSOCIATION BETWEEN RECURRENT PREGNANCY LOSS AND INSULIN RESISTANCE |
6 WEEKS POST PARTUM AND POST ABORTION |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO FIND ASSOCIATION BETWEEN RECURRENT PREGNANCY LOSS AND OXIDATIVE, INFLAMMATORY STRESS MARKERS |
6 WEEKS POST PARTUM AND POST ABORTION |
|
|
Target Sample Size
|
Total Sample Size="158"
Sample Size from India="158"
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)
|
05/02/2024 |
| 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="2"
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
|
Our study aims to find relation between insulin resistance,
inflammatory markers and oxidative stress in women with recurrent pregnancy loss. If at all
association exists then we can formulate an early surveillance policy for insulin resistance and its management which can help in improving the prognosis of future
pregnancy with better outcome |