| CTRI Number |
CTRI/2026/01/100752 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Maternal complications in high BMI pregnant women |
|
Scientific Title of Study
|
A prospective comparitive study on association of maternal body mass index with
haemodynamic and vascular alterations at 35-37 weeks of gestation |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Likhitha R Gowda |
| Designation |
Junior resident |
| Affiliation |
BLDE, SRI BM PATIL MEDICAL COLLEGE |
| Address |
NRI house, 6th cross,Indranagar, Hassan
Indranagar,
Hassan
KARNATAKA
573201
India |
| Phone |
07760579950 |
| Fax |
|
| Email |
likhithagowda64687@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shobha shiragur |
| Designation |
Professor |
| Affiliation |
BLDE, SRI BM PATIL MEDICAL COLLEGE |
| Address |
BM patil medical college and research centre
Bijapur
KARNATAKA
586103
India |
| Phone |
9663330846 |
| Fax |
|
| Email |
shobha.shiragur@bldedu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Likhitha R Gowda |
| Designation |
Junior resident |
| Affiliation |
BLDE, SRI BM PATIL MEDICAL COLLEGE |
| Address |
NRI house, 6th cross,Indranagar, Hassan
Indranagar,
Hassan
KARNATAKA
573201
India |
| Phone |
07760579950 |
| Fax |
|
| Email |
likhithagowda64687@gmail.com |
|
|
Source of Monetary or Material Support
|
| SHRI BM PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, VIJAYAPUR, Karnataka, India 586103 |
|
|
Primary Sponsor
|
| Name |
Dr Shobha shiragur |
| Address |
SHRI BM PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, BIJAPUR, Karnataka, India 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 Likhitha R Gowda |
SHRI B M PATIL MEDICAL COLLEGE,HOSPITAL AND RESEARCH CENTRE |
Department of OBG,OPDno 2 Bangaramma Sajjan Campus B M patil Road, Vijayapura- 586103
Bijapur
KARNATAKA |
7760579950
likhithagowda64687@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Women with singleton pregnancy delivering a non malformed liveborn neonate |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To asses the cardiac output, uterine artery pulsatality index ans other hemodynamic indeces in obese pregnant women |
35 to 37 weeks of gestation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To asses the perinatal outcome associated with BMI |
35- 37 weeks of gestation |
|
|
Target Sample Size
|
Total Sample Size="262"
Sample Size from India="262"
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)
|
12/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/01/2026 |
| 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)
|
Open to Recruitment |
| 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
|
The study aims to evaluate the body mass index (BMI) at 11to 13 weeks and assess maternal hemodynamic and vascular parameters at 35 to 37 weeks of pregnancy. It will also investigate how increased maternal BMI and gestational weight gain affect these parameters and examine pregnancy outcomes associated with obesity.
|