| CTRI Number |
CTRI/2025/08/093117 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of correlation of ductus venous doppler changes and fetal outcome in pregnant women with pre-ecclampsia |
|
Scientific Title of Study
|
A prospective observational study of correlation of ductus venous doppler and fetal outcome in Pre-ecclampsia |
| 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 Vinaya Patil |
| Designation |
Post Graduate |
| Affiliation |
Shri B. M. Patil medical college hospital and research centre |
| Address |
Shri B. M. Patil medical college hospital and research centre, OPD room no 2, Bangaramma Sajjan Campus, Solapur road, Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
7337812338 |
| Fax |
|
| Email |
vinayapatil786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailaja R Bidri |
| Designation |
Professor and HOD Department of OBG |
| Affiliation |
Shri B. M. Patil medical college hospital and research centre |
| Address |
Shri B. M. Patil medical college hospital and research centre, OPD room no 2, Bangaramma Sajjan Campus, Solapur road, Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9880162550 |
| Fax |
|
| Email |
drsrbidri1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinaya Patil |
| Designation |
Post Graduate |
| Affiliation |
Shri B. M. Patil medical college hospital and research centre |
| Address |
Shri B. M. Patil medical college hospital and research centre, OPD room no 2, Bangaramma Sajjan Campus, Solapur road, Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
7337812338 |
| Fax |
|
| Email |
vinayapatil786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri B M Patil medical college hospital and research centre, Vijaypura, Karnataka India 586103 |
|
|
Primary Sponsor
|
| Name |
Shri B M Patil medical college hospital and research centre Vijayapura |
| Address |
Shri B. M. Patil medical college hospital and research centre Vijayapura 586103 |
| 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 |
| Dr Vinaya Patil |
Shri B M Patil medical college hospital and research centre Vijayapura |
department of OBG
OPD no 2,
Shri B M Patil medical college and research centre ,Solapur road, shri Bangarama Sajjan campus, Vijayapura, 586103, Karnataka, India
Bijapur
KARNATAKA |
7337812338
vinayapatil786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, VIJAYAPURA BLDE (DU) IEC-SBPMC/063/2023-24 Institutional ethical 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 |
35.00 Year(s) |
| Gender |
Female |
| Details |
pregnant women with preeclampsia between 34-40 weeks period of gestation, singleton pregnancy, no underlying medical conditions |
|
| ExclusionCriteria |
| Details |
patients with fetal anomalies, patients with other medical conditions (dm, htn, respiratory, cardiac, renal, liver diseases), patients with chronic hypertension, gestational hypertension, multifetal pregnancy, uncertain gestational age, patients with preeclampsia who are prescribed low molecular weight heparin or aspirin |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess the association between ductus venous doppler changes and perinatal outcome |
on the day 1 of fetal life |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess the association between ductus venous doppler & maternal obstetric outcome |
on post operative day immediate |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
26/08/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vinayapatil786@gmail.com].
- For how long will this data be available start date provided 26-06-2024 and end date provided 26-06-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Pregnant women between 34 to 40 weeks period of gestation with preeclampsia will be selected for the study. Maternal data consisting of patient demographics, past obstetric history, comorbidities and medication use will be collected. Ductus venous doppler analysis will be done and appropriate obstetric care will be given. Patients will be followed up and details regarding the mode of delivery, gestational age at delivery, complications if any during delivery will be collected. Neonatal data including the birth weight, APGAR score, neonatal morbidities, NICU admission will be collected. Chi-square test will be used to determine the association between ductus venous doppler findings and perinatal outcome.
|