| CTRI Number |
CTRI/2025/04/085421 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Labour Outcomes using two different standard guidelines for labour monitoring |
|
Scientific Title of Study
|
Labour Outcomes in WHO Modified Partogram and Labour Care Guide in a Tertiary Care Hospital in South India: A Randomized Control Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Madhu Swetha Sharma |
| Designation |
Assistant Professor |
| Affiliation |
St John’s Medical College Hospital |
| Address |
St John’s Medical college hospital
Sarjapur Road
Koramangala
Bangalore
KARNATAKA
560034
India |
| Phone |
7001995865 |
| Fax |
|
| Email |
madhuswethasharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Madhu Swetha Sharma |
| Designation |
Assistant Professor |
| Affiliation |
St John’s Medical College Hospital |
| Address |
St John’s medical college hospital
Sarjapur Road
Koramangala Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
7001995865 |
| Fax |
|
| Email |
madhuswethasharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Madhu Swetha Sharma |
| Designation |
Assistant Professor |
| Affiliation |
St John’s Medical College Hospital |
| Address |
St John’s medical college hospital
Sarjapur Road
Koramangala Bangalore
Bangalore
KARNATAKA
560038
India |
| Phone |
7001995865 |
| Fax |
|
| Email |
madhuswethasharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| St John’s medical college hospital
Sarjapur Road
Koramangala Bangalore 560034 |
|
|
Primary Sponsor
|
| Name |
St Johns Medical college hospital |
| Address |
St John’s medical college hospital
Sarjapur Road
Koramangala Bangalore 560034 |
| 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 Madhu Swetha Sharma |
Department of Obstetrics and Gynecology, 1st floor labour ward, St John’s medical college hospital |
Sarjapur Road Bangalore 560034
Bangalore
KARNATAKA |
7001995865
madhuswethasharma@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 |
| Healthy Human Volunteers |
Pregnant women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Labour care guide |
In the intervention group we will use the labour care guide to monitor active phase of labour and identify poor labour progress and manage according to the guideline |
| Comparator Agent |
Modified WHO partogram |
In the control group we will monitor labour according to the standardised modified WHO partogram and manage the patient according to the guideline. This is what we are doing currently as part of the hospital protocol |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Singleton pregnancy
More than 34 weeks of gestation |
|
| ExclusionCriteria |
| Details |
Multiple pregnancy
Previous caesarean delivery
Non cephalic presentation
Medical comorbidities
Contracted pelvis
Estimated weight more than 4 kg |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mode of delivery |
10 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mode of delivery
Complications in labour |
3 months |
|
|
Target Sample Size
|
Total Sample Size="190"
Sample Size from India="190"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
05/05/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 WHO partogram has been used for many years to assess the progress of labour. WHO introduced the Labour care guide in 2020 to improve labour outcomes with better patient oriented labour monitoring. It follows the principles of respectful maternity care and provides a positive labour experience for the pregnant women. In this study we compare both types of labour monitoring to assess their impact on labour outcomes and Caesarean rates. |