| CTRI Number |
CTRI/2021/09/036189 [Registered on: 03/09/2021] Trial Registered Prospectively |
| Last Modified On: |
08/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of use of WHO Labor Care Guide. |
|
Scientific Title of Study
|
Impact of use of WHO Labor Care Guide at a tertiary centre: a randomized controlled study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Pandey |
| Designation |
Associate Professor |
| Affiliation |
VMMC and Safdarjung Hospital,Delhi. |
| Address |
Department of Obstetrics and Gynaecology,VMMC and Safdarjung Hospital,Delhi.
Department of Obstetrics and Gynaecology,VMMC and Safdarjung Hospital,Delhi.
South
DELHI
110029
India |
| Phone |
08860198440 |
| Fax |
|
| Email |
dr_devya1@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Divya Pandey |
| Designation |
Associate Professor |
| Affiliation |
VMMC and Safdarjung Hospital,Delhi. |
| Address |
Department of Obstetrics and Gynaecology,VMMC and Safdarjung Hospital,Delhi.
Department of Obstetrics and Gynaecology,VMMC and Safdarjung Hospital,Delhi.
South
DELHI
110029
India |
| Phone |
08860198440 |
| Fax |
|
| Email |
dr_devya1@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Divya Pandey |
| Designation |
Associate Professor |
| Affiliation |
VMMC and Safdarjung Hospital,Delhi. |
| Address |
Department of Obstetrics and Gynaecology,VMMC and Safdarjung Hospital,Delhi.
Department of Obstetrics and Gynaecology,VMMC and Safdarjung Hospital,Delhi.
South
DELHI
110029
India |
| Phone |
08860198440 |
| Fax |
|
| Email |
dr_devya1@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdarjung Hospital,Delhi. |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung Hospital Delhi |
| Address |
VMMC and Safdarjung Hospital,Delhi. |
| Type of Sponsor |
Government medical college |
|
|
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 divya pandey |
VMMC and Safdarjung hospital,New Delhi |
Department of Obstetrics and Gynaecology,VMMC and Safdarjung Hospital,Delhi.
New Delhi
DELHI |
08860198440
dr_devya1@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,VMMC and Safdarjung Hospital,Delhi. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, (2) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Use of Modified WHO partograph(2000)for labor monitoring in control group. |
Modified WHO Partograph(2000) will be used to monitor labor once woman in control group, is in active phase of labor. |
| Intervention |
Use of WHO Labor Care Guide(2020) for labor monitoring in study group. |
WHO Labor Caer Guide(2020) will be used to monitor labor once woman in study group is in active phase of labor. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant women with period of gestation 37-40 weeks with cephalic presentation in spontaneous labor. |
|
| ExclusionCriteria |
| Details |
1. Pregnant women with any medical co-morbidities like hypertension, Diabetes mellitus, Renal disease, pulmonary disease.
2. Pregnant women with any obstetric co-morbidities like pre-term, multiple gestation, breech, post-dated pregnancy,Bad Obstetric History .
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome
1.)Maternal outcome-
a. duration of active phase
b. mode of delivery
c. Duration of hospital stay
2) Fetal Outcome
a. Apgar Score(at 5 minutes)
b. NICU Admission.
|
during labor and till discharge from hospital. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome
1) Maternal complications: PPH/Hematoma/Infection/fever.
2) Feedback
a) Acceptability
b) Suggestions for improvement
|
during labor and till discharge from hospital. |
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/09/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Background WHO came up with, “Next-generation Partograph†i.e. The Labor Care Guide(LCG) in December,2020.This new partograph was designed with aim to promote individualised labor monitoring with woman-oriented care and to encourage critical decision making while labor monitoring.WHO has recommended implementation of new partograph (LCG) after evaluating its application for individual centres. Hence this project is aimed to evaluate the impact of WHO LCG for labor monitoring with respect to materno-fetal outcomes.
|