| CTRI Number |
CTRI/2024/07/070249 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [labor monitoring using 2 different labor monitoring tool. ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Labor monitoring tools, WHOs Labor care guide the next generation partograph (2020) is comapred with modified WHOs partograph (2000) .Fetomaternal outcome and cesarean delivery rate in singleton pregnancy in both the groups are assessed. |
|
Scientific Title of Study
|
To compare the WHOs Labor care guide ,the next generation partograph (2020) versus modified WHOs partograph (2000) in improving overall fetomaternal outcome and reducing cesarean delivery rate in singleton pregnancy: an open labelled 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 |
Aishwarya Honwad |
| Designation |
junior resident , obstetrics and gynaecology |
| Affiliation |
ALL INDIA INSTITUE OF MEDICAL SCIENCE , RAIPUR |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY , AIIMS RAIPUR . CHATTISGARH.
Raipur
CHHATTISGARH
492099
India |
| Phone |
7204681464 |
| Fax |
|
| Email |
aishwaryahonwad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandrashekhar Shrivastav |
| Designation |
Associate professor |
| Affiliation |
ALL INDIA INSTITUE OF MEDICAL SCIENCE , RAIPUR .TATIBANDH 492099. CHATTISGARH |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY .
ALL INDIA INSTITUE OF MEDICAL SCIENCE , RAIPUR
Raipur
CHHATTISGARH
492099.
India |
| Phone |
7000599101 |
| Fax |
|
| Email |
chandan_1708@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandrashekhar Shrivastav |
| Designation |
Associate professor |
| Affiliation |
ALL INDIA INSTITUE OF MEDICAL SCIENCE , RAIPUR .TATIBANDH 492099. CHATTISGARH |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY .
ALL INDIA INSTITUE OF MEDICAL SCIENCE , RAIPUR .
Raipur
CHHATTISGARH
492099.
India |
| Phone |
7000599101 |
| Fax |
|
| Email |
chandan_1708@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUE OF MEDICAL SCIENCE, RAIPUR.TATIBANDH
492099.CHATTISGARH. INDIA . |
|
|
Primary Sponsor
|
| Name |
AISHWARYA HONWAD |
| Address |
Dept of OBSTETRICS AND GYNAECOLOGY. AIIMS RAIPUR.
492099
CHATTISGARH.INDIA |
| Type of Sponsor |
Other [SELF ] |
|
|
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 AISHWARYA HONWAD |
AIIMS RAIPUR , |
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY ,LABOR ROOM,A-BLOCK 1ST FLOOR.
Raipur
CHHATTISGARH |
7204681464
aishwaryahonwad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institute ethics committe , AIIMS RAIPUR . |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O30-O48||Maternal care related to the fetus and amniotic cavity and possible delivery problems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
WHOs labor care guide |
labor monitoring , mode of delivery , cesarean delivery rate & fetomaternal outcome. pt is monitored from active stage of labor till delivery of baby & discharged from the hospital . & follow up after 6 weeks of delivery . |
| Comparator Agent |
WHOs modified partograph. |
labor monitoring , mode of delivery , cesarean delivery rate & fetomaternal outcome. pt is monitored from active stage of labor till delivery of baby & discharged from the hospital . & follow up after 6 weeks of delivery . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
all antenatal women between 37-40 wks .
singleton ,cephalic presentation. |
|
| ExclusionCriteria |
| Details |
multiple gestation
preterm /post dated
malpresentation
obstetric complications.
on epidural analgesia ,
women wih preeclamsia with severe features.
medical diorders - cardiac disease . pulmonary , renal disease . |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
RATE OF CESAEREAN DLIVERY
|
AT DELIVERY . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of fetal distress
Incidence of MSL/MAS
Incidence of birth asphyxia
Incidence if NICU admission
Birth weight,
Respiratory distress in newborn
Level of care required in NICU
|
Apgar score at birth
FOLLOW UP AT 6 WEEKS
- |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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 3 |
|
Date of First Enrollment (India)
|
30/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/06/2024 |
| 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)
|
Not Applicable |
| 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
|
Rapidly increasing global caesarean section rates without clear evidence of positive impact on maternal or neonatal morbidity or mortality has raised significant concern over caesarean section rates. WHO introduced the WHO Labour Care Guide, the next-generation partograph to provide respectful and supportive maternal care by documentation of numeric figures for parameters being monitored and precise threshold limits to trigger intervention after maternofetal assessment. There are not many studies done to evaluate the effect of the WHO LCG on reducing caesarean delivery rates and overall maternofetal outcomes. In light of rising caeserian section rate , this study will be done to determine the effect of WHO’s LCG on reducing caesarean delivery rates and improving overall maternofetal outcomes by comparing it with the existing WHO- modified partograph. |