| CTRI Number |
CTRI/2025/04/085062 [Registered on: 17/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Labour Outcome using WHO Labour Care Guide Versus WHO Modified Partograph by Comparative Observational Study |
|
Scientific Title of Study
|
A Comparative Observational study on WHO Labour Care Guide Versus WHO Modified Partograph on Labour Outcome
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kurukuntla Vishnupriya |
| Designation |
Junior Resident(POST GRADUATE) |
| Affiliation |
Shri B.M Patil Medical College Hospital and Research Centre |
| Address |
OBG Opd No.2, Department of OBG, Shri B.M Patil Medical College Hospital and Research Centre, Bangaramma Sajjan campus, Solapur road, Vijayapura, 586103, Bijapur, Karnataka, India.
Bijapur
KARNATAKA
586103
India |
| Phone |
9441485273 |
| Fax |
|
| Email |
vishnupriya231998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shreedevi Kori |
| Designation |
Associate Professor |
| Affiliation |
Shri B.M Patil Medical College Hospital and Research Centre |
| Address |
OBG Opd No.2, Department of OBG, Shri B.M Patil Medical College Hospital and Research Centre, Bangaramma Sajjan campus, Solapur road, Vijayapura, 586103, Bijapur, Karnataka, India.
Bijapur
KARNATAKA
586103
India |
| Phone |
9538846839 |
| Fax |
|
| Email |
shree_kori@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Kurukuntla Vishnupriya |
| Designation |
Junior Resident(POST GRADUATE) |
| Affiliation |
Shri B.M Patil Medical College Hospital and Research Centre |
| Address |
OBG Opd No.2, Department of OBG, Shri B.M Patil Medical College Hospital and Research Centre, Bangaramma Sajjan campus, Solapur road, Vijayapura, 586103, Bijapur, Karnataka, India.
Bijapur
KARNATAKA
586103
India |
| Phone |
9441485273 |
| Fax |
|
| Email |
vishnupriya231998@gmail.com |
|
|
Source of Monetary or Material Support
|
| OBG Opd No.2, Department of OBG, Shri B.M Patil Medical College Hospital and Research Centre, Bangaramma Sajjan campus, Solapur road, Vijayapura, 586103, Bijapur, Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
SHRI BM PATIL MEDICAL COLLEGE HOSPITAL RESEARCH CENTRE |
| Address |
OBG Opd No.2, Department of OBG, Shri B.M Patil Medical College Hospital and Research Centre, Bangaramma Sajjan campus, Solapur road, Vijayapura, 586103, Bijapur, Karnataka, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 VISHNUPRIYA |
Shri B.M Patil Medical College Hospital and Research Centre |
OBG Opd No.2, Department of OBG, Shri B.M Patil Medical College Hospital and Research Centre, Bangaramma Sajjan campus, Solapur road, Vijayapura, 586103, Karnataka, India.
Bijapur
KARNATAKA |
9441485273
vishnupriya231998@gmail.com |
|
|
Details of Ethics Committee
|
| 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: O679||Intrapartum hemorrhage, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
All Primigravida with Term Gestation With No Comorbidities With Cephalic Presentation. |
|
| ExclusionCriteria |
| Details |
Caesarean Section in Latent Phase of Labour, H/o Previous caesarean sections, H/o PIH, H/o Preterm Delivery, H/o Breech Presentation, H/o Prior Bad Obstetric History, H/o Gestational Diabetes Mellitus .
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mode Of Delivery and Neonatal Outcome |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time taken for Active Labour, Maternal Complications, Hospital Stay Duration,
APGAR Score. |
6 Weeks |
|
|
Target Sample Size
|
Total Sample Size="146"
Sample Size from India="146"
Final Enrollment numbers achieved (Total)= "146"
Final Enrollment numbers achieved (India)="146" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2025 |
| Date of Study Completion (India) |
30/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Labour is the most crucial part of every womens life. Successful delivery involves maternal efforts, uterine contractions, fetal characteristics and pelvic anatomy. Maternal mortality during labour is a disastrous incident. Maternal mortality results due to no timely interventions done during labour. To reduce these deaths early recognition by intense labour monitoring is required.(1) WHO Labour Care Guide(LCG) - a monitoring tool used during labour in known to decrease the complications during delivery and also decreasing caesarean sections.(2) WHO Labor care guide provide better health and wellbeing of women and the neonatal outcome by including parameters that are not present in WHO Modified Partograph.(3) Supportive care during labour and maternal wellbeing is considered in LCG to reduce of maternal, perinatal mortality and morbidity.(4) WHO modified partograph is an old tool used for plotting maternal and fetal condition during active stage of labour which doesnt include 2nd stage of labour and intensive maternal care. So in my study I want to compare WHO LCG versus WHO Modified Partograph to assess labour outcome and also to know the impact of these tools on caesarean delivery rates. PURPOSE : TO DECREASE THE MORTALITY AND MORBIDITY RATES OF NEONATES |