| CTRI Number |
CTRI/2023/05/053172 [Registered on: 26/05/2023] Trial Registered Prospectively |
| Last Modified On: |
25/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing WHO Labour Care Guide with WHO Modified Partograph and its effect on reduction of caesarean section rate |
|
Scientific Title of Study
|
Comparing WHO Labour Care Guide with WHO Modified Partograph and its effect on reduction of caesarean section rate in an apex healthcare institute: an open-label randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jasmina Begum |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Obstetrics and Gynaecology,AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9443392737 |
| Fax |
|
| Email |
jasminaaly@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jasmina Begum |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Obstetrics and Gynaecology,AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9443392737 |
| Fax |
|
| Email |
jasminaaly@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Laveti Sai Sarvazna |
| Designation |
Post Graduate |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Obstetrics and Gynaecology,AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9848198680 |
| Fax |
|
| Email |
sslaveti7@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Bhubanesdwar |
| Address |
AIIMS Bhubaneswar, Sijua, Patrapada, Bhubaneswar |
| 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 Jasmina Begum |
All India Institute of Medical Sciences, Bhubaneswar |
Labour Room, Department of Obstetrics And Gynaecology
Khordha
ORISSA |
09443392737
jasminaaly@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS BBSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
WHO Labour Care Guide |
The total Duration of the intervention will be 18 hours.
As it is a labour monitoring tool. Frequency, route of administration, dose is not applicable.
|
| Comparator Agent |
WHO Modified Partograph |
The total duration of the intervention will be 18 hours.
As it is a labour monitoring tool.
Frequency, route of administration, dose is not applicable. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Nulliparous and multiparous women with singleton pregnancy
with cephalic presentation
with more than or equal to 37 weeks of gestation
in spontaneous labour or induced labour
|
|
| ExclusionCriteria |
| Details |
1) Nulliparous or multiparous pregnant women with previous CS
2) Nulliparous or multiparous women with malpresentations
3) Nulliparous or multiparous women with multiple pregnancies
4) Nulliparous or multiparous women with IUFD
5) Nulliparous or multiparous women with APH
6) Nulliparous or multiparous women with pregnancy less than 37 weeks gestation
7)Pregnant women with mental illness
8) Pregnant women with a fetal anomaly
9) Patient not giving consent for study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mode of delivery |
14 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fetomaternal outcomes, maternal childbirth satisfaction and physicians satisfaction with Labour Care Guide |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
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)
|
07/06/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/06/2023 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study aims to compare the WHO Labour Care Guide with the existing WHO Modified Partograph on reducing caesarean section rate in pregnant women and will compare the overall maternal and neonatal outcomes with the existing WHO modified partograph. The study has aimed to determine the health care providers feedback on the difficulty, acceptability, satisfaction and utility levels of the LCG. This study will be the first to compare the maternal childbirth satisfaction rate by using Mackey Childbirth Satisfaction rating scale which is a 34 items questionnaire which measures mother satisfaction with the labour and childbirth experience in both the groups and will assess its relationship with the different stages of labour. |