| CTRI Number |
CTRI/2024/03/064820 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
03/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
MATERNAL SERUM C-REACTIVE PROTEIN LEVELS AS A MARKER OF PRETERM LABOUR |
|
Scientific Title of Study
|
ROLE OF MATERNAL SERUM C-REACTIVE PROTEIN LEVELS IN EARLY SECOND TRIMESTER AS A MARKER OF PRETERM LABOUR |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sravya Gudapati |
| Designation |
Junior resident |
| Affiliation |
Datta meghe institute of higher education and research |
| Address |
Obstetrics and Gynecology department,
Jawaharlal nehru medical college,
Sawangi Meghe,
Wardha
Maharashtra
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
09849319535 |
| Fax |
|
| Email |
sravyagudapati08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kamlesh Chaudhari |
| Designation |
Proffessor |
| Affiliation |
proffessor, DMIHER |
| Address |
Jawaharlal nehru medical college,
Sawangi Meghe,
Wardha
Maharashtra
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
|
| Fax |
|
| Email |
dr.kamleshchaudhari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kamlesh Chaudhari |
| Designation |
Proffessor |
| Affiliation |
proffessor, DMIHER |
| Address |
Jawaharlal nehru medical college,
Sawangi Meghe,
Wardha
Maharashtra
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
|
| Fax |
|
| Email |
dr.kamleshchaudhari@gmail.com |
|
|
Source of Monetary or Material Support
|
| DMIMHER,Sawangi Meghe,
Wardha |
|
|
Primary Sponsor
|
| Name |
JNMC |
| Address |
Sawangi Meghe,
Wardha |
| 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 |
| Sravya Gudapati |
DMIMHER |
Obstetrics and Gynaecology department, Sawangi Meghe, Wardha.
Wardha
MAHARASHTRA |
9849319535
sravyagudapati08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O20-O29||Other maternal disorders predominantly related to pregnancy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NONE |
NONE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.All cases of singleton gestation (confirmed by early second trimester ultrasound).
2.Gestational age between 14-20 weeks (by LMP and confirmed by ultrasound).
3.Intact amniotic membranes.
|
|
| ExclusionCriteria |
| Details |
1.Multiple gestation.
2.Gestational age less than 13 weeks or more than 20 completed weeks.
3.Patients with premature rupture of membranes.
4.Pregnancies complicated by Pre-eclampsia, Gestational diabetes mellitus, heart disease.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
•Preterm and full-term delivery
•Mode of delivery
|
early second trimester |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Fetal outcome will be assessed in terms of weight at the time of birth, APGAR score at one and five minutes, NICU admission, neonatal complications. |
7MONTHS |
|
|
Target Sample Size
|
Total Sample Size="113"
Sample Size from India="113"
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)
|
31/05/2024 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
ROLE OF MATERNAL SERUM C-REACTIVE PROTEIN LEVELS IN EARLY SECOND TRIMESTER AS A MARKER OF PRETERM LABOURTo study the role of maternal serum C- reactive protein levels in early second trimester as a marker of preterm labor. To compare between the women with preterm delivery with normal CRP levels and women with preterm delivery with altered CRP levels. |