CTRI Number |
CTRI/2021/10/037302 [Registered on: 13/10/2021] Trial Registered Prospectively |
Last Modified On: |
26/03/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Process of Care Changes |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
To study the effect on cesarean section rate by monitoring the labor progression with the use of 2 different partographs |
Scientific Title of Study
|
To compare the rate of cesarean section with the use of new WHO partograph and the old WHO partograph - A randomized controlled trial |
Secondary IDs if Any
Modification(s)
|
Secondary ID |
Registry |
Nil |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
Name |
Dr Sonal Agarwal |
Address |
AIIMS, Jodhpur, Basni Industrial Area, MIA 2nd Phase, Basni, Jodhpur, Rajasthan
Jodhpur RAJASTHAN 342005 India |
Phone |
9511563850 |
Fax |
|
Email |
drsonalagarwal501@gmail.com |
|
Details Contact Person Scientific Query
Modification(s)
|
Name |
Dr Pratibha Singh |
Address |
AIIMS, Jodhpur, Basni Industrial Area, MIA 2nd Phase, Basni, Jodhpur, Rajasthan
Jodhpur RAJASTHAN 342005 India |
Phone |
8003996941 |
Fax |
|
Email |
drpratibha69@hotmail.com |
|
Details Contact Person Public Query
Modification(s)
|
Name |
Dr Pratibha Singh |
Address |
AIIMS, Jodhpur, Basni Industrial Area, MIA 2nd Phase, Basni, Jodhpur, Rajasthan
Jodhpur RAJASTHAN 342005 India |
Phone |
8003996941 |
Fax |
|
Email |
drpratibha69@hotmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
AIIMS Jodhpur |
Address |
AIIMS Jodhpur |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 1 |
Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Sonal Agarwal |
All India Institute Of Medical Sciences, Jodhpur |
Department of Obstetrics and Gynaecology, D&T block, second floor, Labor Room Jodhpur |
9511563850
drsonalagarwal501@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committe, AIIMS Jodhpur |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Encounter for full-term uncomplicated delivery |
|
Intervention / Comparator Agent
Modification(s)
|
Type |
Name |
Details |
Comparator Agent |
Old WHO Partograph |
labour progression in the control group will be monitored via the old WHO Partograph, from onset of active phase of first stage of labour |
Intervention |
WHO Labour Care Guide (new WHO Partograph) |
labour progression in the intervention group will be monitored via the WHO Labour Care Guide which is the new WHO Partograph, from onset of active phase of first stage of labour till second stage of labour |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Female |
Details |
All pregnant women (both primigravida and multigravida) with singleton pregnancy at >36 weeks gestation admitted for vaginal delivery. |
|
ExclusionCriteria |
Details |
1. Women admitted for elective LSCS.
2. Women with multifetal pregnancy.
3. Women with malpresentation.
4. Women with h/o uterine surgery eg: cesarean section, myomectomy etc.
5. Women with contracted pelvis or cephalopelvic disproportion.
6. Patients not giving consent
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To Compare the rate of cesarean section with the use of New WHO Partograph And The Old WHO Partograph in labouring antenatal females. |
from onset of active phase of first stage of labour till second stage of labour |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. To compare the duration of labour with the use of new WHO partograph and the old WHO partograph.
2. To assess ease of use, acceptability and feasibility of the new WHO partograph among health care practitioners (Doctors and Nurses) in the labour room.
3. To compare neonatal outcome with the use of the new WHO partograph and the old WHO partograph.
4. To assess patient satisfaction.
|
during labour and immediate postnatal period |
|
Target Sample Size
|
Total Sample Size="570" Sample Size from India="570" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
18/10/2021 |
Date of First Enrollment (Global) |
No Date Specified |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
Brief Summary
|
In November
2020, the WHO introduced the new WHO partograph based on WHO’s latest
intrapartum care recommendations which include updated definitions for first
and second stage of labour, based on evidence from systematic review.
To the best of our
knowledge this is the first study to compare the new WHO partograph and the old
WHO partograph. The cesarean delivery rates in India over the past years show a
rising trend, exceeding the WHO recommended rate of 10-15%. We
hereby aim to
compare the new WHO partograph
and the old
WHO partograph to reduce cesarean
section rate.
Our primary
objective is to compare the rate of cesarean section with the use of the new
WHO partograph and the old WHO partograph. Our secondary objectives are to:
(a) (a)
compare duration of labour,
(b)
to compare neonatal outcome,
(c)
to assess ease of use, acceptability
and feasibility of the new WHO partograph, and
(d)
to assess patient satisfaction.
All the women at period of gestation >36 weeks,
admitted for vaginal delivery and fulfilling inclusion criteria will be
recruited for the study. Subjects will be allocated into intervention and
control group on the basis of randomization. Simple randomization with 1:1 allocation will be
followed. Computer generated Random sequences will be generated by online
software (https://www.sealedenvelope.com/simple-randomiser/v1/lists)
by an individual not involved in enrollment, treatment and follow up of study.
Random sequences will be used to make
identical, opaque, sealed envelopes with Unique random number written over the envelope. These
envelopes will be made by a person not involved
in enrollment, treatment and follow up of study. These envelopes will be
kept in the Department office for safe-keeping.Every time, the eligible patient gives
consent for the study, one Random closed envelop will be picked by person not
involved in the study. It will be handed over to the investigator. According to
the code written in the letter, Patient will be allocated in group A
(intervention group) or group B (control group).
Progression of
labour will be monitored in intervention (group A) and control group (group B)
with the help of the new and the old WHO partograph respectively. If the
outcomes with the use of the new WHO partograph are favourable as compared to
the old WHO partograph, it will be a valuable tool for achieving reduction in
cesarean section rate.
|