| CTRI Number |
CTRI/2024/04/065086 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
28/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Hs CRP level in pre eclampsia |
|
Scientific Title of Study
|
STUDY OF HIGH SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) LEVELS IN EARLY AND LATE ONSET PRE ECLAMPSIA IN A TERTIARY CARE HOSPITAL - ONE YEAR CROSS SECTIONAL 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 |
CHINTAKINDI Preethi |
| Designation |
PG Resident |
| Affiliation |
JNMC, KLE University. |
| Address |
KLE University, Jawaharlal Nehru Medical College, Nehru nagar.
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8978462698 |
| Fax |
|
| Email |
preethi.chintakindi273@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahadevi Savanur |
| Designation |
Assistant Professor, Obstetrics and Gynaecology |
| Affiliation |
JNMC, KLE University |
| Address |
KLE University, Jawaharlal Nehru Medical College, Nehru nagar.
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9880515045 |
| Fax |
|
| Email |
drdevim30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chintakindi Preethi |
| Designation |
PG Resident |
| Affiliation |
JMNC, KLE University |
| Address |
KLE University, Jawaharlal Nehru Medical College, Nehru nagar
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8978462698 |
| Fax |
|
| Email |
preethi.chintakindi273@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEH, Dr Prabhakar kore hospital, JNMC, Belagavi |
|
|
Primary Sponsor
|
| Name |
Chintakindi Preethi |
| Address |
Room no. 212; New PG Ladies hostel, JNMC Campus, KLE University, Belagavi, Karnataka. India, Pin code- 590010 |
| 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 |
| Chintakindi Preethi |
Jawarharlal Nehru Medical College, KLEH, BELAGAVI |
G-1, OBGYN Labour room,KLE Dr Prabhakar Kore Hospital, Nehru Nagar, Belagaum, Karnataka
Belgaum
KARNATAKA |
8978462698
preethi.chintakindi273@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O140||Mild to moderate pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. All preeclamptic pregnant women who are admitted in antenatal ward or labour room
2. Singleton pregnancy
3. Pre eclamptic women willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1. Preeclamptic women with history of fever or recent infections or who are receiving antibiotic treatment or steroids.
2. Preeclamptic women in labour or presenting with PROM or clinical chorioamnionitis.
3. Preeclamptic women with chronic inflammatory disorders like arthritis, inflammatory bowel disorders, SLE etc.
4. Preeclamptic women with medical disorders (Diabetes mellitus, hepatic disorders, renal disorders)
5. Pregnant women whose BMI > 25kg/m2 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study high sensitive c reactive protein levels in early onset pre ecclampsia and late onset pre ecclampsia in pregnancy |
20 weeks - 40 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fetomaternal outcome in raised hsCRP Levels |
1 month |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
15/04/2024 |
| 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
|
Need for the study There are no studies regarding hs CRP levels in early onset and late onset preeclampsia. This study aims to assess the significance of hs CRP levels in early and late onset preeclampsia and its clinical significance in maternal and fetaloutcome. If proved significant hs CRP can be used as a prognostic indicator in severe pre eclampsia in low resource settings as it is more economical compared to other placental biomarkers like PlGF and Sflt1in preeclampsia.
Study Protocol All antenatal women diagnosed with pre eclampsia beyond 20 weeks of period of gestation admitted in antenatal ward or labour room at KLE Dr Prabhakar kore hospital and medical research centre associated to KAHER’s Jawaharlal Nehru Medical College, Belagavi will be recruited in this study. They will be asked to sign the informed consent and enrolled for the study The patients who satisfy the inclusion criteria and do not fall under exclusion criteria are recruited in the study. Venous blood sample will be taken from antenatal women diagnosed with preeclampsia beyond 20 weeks of gestation and sent for investigation along with other biochemical parameters. The sample will be centrifuged and hsCRP level will be measured by immunoturbidimetry method. The final diagnosis will be made after noting the investigations and the patient will be categorized into early onset preeclampsia and late onset preeclampsia according to their definitions |