| CTRI Number |
CTRI/2023/10/059019 [Registered on: 23/10/2023] Trial Registered Prospectively |
| Last Modified On: |
24/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of miRNA -210 as prognostic marker of pre-eclampsia |
Scientific Title of Study
Modification(s)
|
EVALUATION OF miRNA - 210 AS PROGNOSTIC BIOMARKER OF PRE-ECLAMPSIA - A CASE CONTROL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KOTA SAI MEGHANA |
| Designation |
PG STUDENT |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
OPD NO 2 SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
SHRI BANGARAMMA SAJJAN CAMPUS
VIJAYAPURA
OPD NO 2 SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE SHRI BANGARAMMA SAJJAN CAMPUS
VIJAYAPURA
586103
Bijapur
KARNATAKA
586103
India |
| Phone |
7032974806 |
| Fax |
|
| Email |
kotameghana7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAJASRI G YALIWAL |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
OPD NO 2 SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
SHRI BANGARAMMA SAJJAN CAMPUS
VIJAYAPURA
OPD NO 2 SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
SHRI BANGARAMMA SAJJAN CAMPUS
VIJAYAPURA
Bijapur
KARNATAKA
586103
India |
| Phone |
9845152240 |
| Fax |
|
| Email |
ryaliwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
K SAI MEGHANA |
| Designation |
PG STUDENT |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
OPD NO 2 SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
SHRI BANGARAMMA SAJJAN CAMPUS
VIJAYAPURA
OPD NO 2 SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
SHRI BANGARAMMA SAJJAN CAMPUS
VIJAYAPURA
Bijapur
KARNATAKA
586103
India |
| Phone |
7032974806 |
| Fax |
|
| Email |
kotameghana7@gmail.com |
|
|
Source of Monetary or Material Support
|
| SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
|
|
Primary Sponsor
|
| Name |
DR KOTA SAI MEGHANA |
| Address |
OPD NO 2 SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
SHRI BANGARAMMA SAJJAN CAMPUS
VIJAYAPURA 586103 |
| 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 |
| KOTA SAI MEGHANA |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
OPD NO 2 SHRI BANGARAMMA SAJJAN CAMPUS, ASHRAM ROAD
Bijapur
KARNATAKA |
7032974806
kotameghana7@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Evaluating miRNA 210 in non pre-eclampsia women |
Evaluating miRNA 210 in non pre-eclampsia women by genetic analyis- Serum isolation is obtained by centrifugation at 1600 rpm for 15 minutes. The samples were recentrifuged at 14,000 rpm for 10 min to precipitate cell debris, and the supernatants were kept at 80 °C until the extraction of RNA. The concerned primer is tagged. Further, RT-PCR analysis is done and the expression level will be determined using 2-ΔΔ Ct and normalized to βactin and represented as fold change. |
| Intervention |
Evaluating miRNA 210 in pre eclampsia women as prognostic marker |
Evaluating miRNA 210 in pre eclampsia women by genetic analyis- Serum isolation is obtained by centrifugation at 1600 rpm for 15 minutes. The samples were recentrifuged at 14,000 rpm for 10 min to precipitate cell debris, and the supernatants were kept at 80 °C until the extraction of RNA.The concerned primer is tagged. Further, RT-PCR analysis is done and the expression level will be determined using 2-ΔΔ Ct and normalized to βactin and represented as fold change. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1 Any pregnant woman with BP more than or equal to 140/90mmhg with two readings measured 6 hours apart with significant proteinuria (more than or equal to 300 mg of protein in a 24hr urine specimen or more than or equal to 1+ by dipstick) following 20 weeks of gestation in a previously normotensive woman
2 Pregnant women age more than or equal to 18
3 Singleton pregnancy
4 Prenatal care at BLDE
|
|
| ExclusionCriteria |
| Details |
1 Any congenital fetal malformations or chromosomal abnormalities
2 Chronic Hypertension
3 Twins with pre eclampsia
4 Renal disease with pre eclampsia
5 Cardiac disease with pre eclampsia
6 Recent infection
7 APLA Syndrome |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the upregulation of miRNA 210 gene in pre-eclamptic women compared to normal healthy pregnant women |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To correlate the severity of pre-eclampsia in pregnant women with the gene expression.
To correlate the fetal outcome with respect to fetal growth restriction, oligohydramnios, low birth weight, neonatal asphyxia, NICU admission.
|
2 years |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
30/10/2023 |
| 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="6"
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 case-control study will be done in the Department of Obstetrics and Gynaecology B.L.D.E (DEEMED TO BE UNIVERSITY) SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, VIJAYAPURA, KARNATAKA, INDIA, Any pregnant woman with BP >=140/90mmhg with two readings measured 6 hours apart, with significant proteinuria (≥300 mg of protein in a 24-h urine specimen or ≥1+ by dipstick) following 20 weeks of gestation in a previously normotensive woman will be considered in this study as GROUP 1.
GROUP 2 - considered are the normotensive pregnant women.
The Non- hypertensive pregnant women of the same gestational age are matched with pregnant women of the same gestational age and followed up till delivery. Age shall be matched with +/- 2 years, and gestational age shall be matched with +/-1 week. Adverse outcomes if any, in the mother and fetus shall be recorded.
The primary outcome is to determine the upregulation of miRNA 210 gene expression in pre-eclamptic women compared to normal healthy pregnant women. To correlate the severity of pre-eclampsia in
pregnant women with gene expression. |