| CTRI Number |
CTRI/2024/02/062746 [Registered on: 16/02/2024] Trial Registered Prospectively |
| Last Modified On: |
14/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Neonatal Outcome In Meconium Stained Amniotic Fluid A Cross sectional Study |
|
Scientific Title of Study
|
Perinatal Outcome In Meconium Stained Liquor A Cross Sectional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tulika Prasad |
| Designation |
Junior resident |
| Affiliation |
Rohilkhand Medical College Hospital |
| Address |
OBGY Department Rohilkhand Medical College Hospital Pilibhit Bypass Road Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9608040155 |
| Fax |
|
| Email |
tulikaprasad8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tripti Gupta |
| Designation |
Professor |
| Affiliation |
Rohilkhand Medical College Hospital |
| Address |
OBGY Department Rohilkhand Medical College Hospital Pilibhit Bypass Road Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8433288211 |
| Fax |
|
| Email |
dr.triptigupta@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tripti Gupta |
| Designation |
Professor |
| Affiliation |
Rohilkhand Medical College Hospital |
| Address |
OBGY Department Rohilkhand Medical College Hospital Pilibhit Bypass Road Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8433288211 |
| Fax |
|
| Email |
dr.triptigupta@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand Medical college,bareilly |
|
|
Primary Sponsor
|
| Name |
ROHILKHAND MEDICAL COLLEGE HOSPITAL |
| Address |
Rohilkhand Medical College and Hospital, Pilibhit Bypass Road Suresh Sharma Nagar Bareily |
| Type of Sponsor |
Private 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 TULIKA PRASAD |
Labour room,RMCH |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL,PILIBHIT BYPASS ROAD BAREILLY
Bareilly
UTTAR PRADESH |
9608040155
dr.tulikaprasad8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, RMCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O419||Disorder of amniotic fluid and membranes, unspecified, (2) ICD-10 Condition: O419||Disorder of amniotic fluid and membranes, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
All pregnant females with term pregnancies, cephalic presentation and singleton pregnancy |
|
| ExclusionCriteria |
| Details |
Congenital malformation
Intrauterine fetal death
Breech presentation
Oligphydroamnios |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess maternal and perinatal outcome in patients with meconium stained liquor during labour |
To assess maternal and perinatal outcome in patients with meconium stained liquor during labour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the association of meconium stained amniotic
fluid with abnormal CTG during labour |
37-42 weeks |
|
|
Target Sample Size
|
Total Sample Size="155"
Sample Size from India="155"
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)
|
24/02/2024 |
| 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="1"
Months="0"
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
|
Study subjects will be recruited in the study after approval of study with institutional ethics committee RMCH, Bareilly. Informed written consent will be obtained from participants. Patients of spontaneous or induced labour who will have meconium stained amniotic fluid at any point of time in labourwill be involved in study & will be kept on continous CTG monitoring. Immediate perinatal outcome will be seen ,APGAR Scorewill be calculated, presence of respiratory distress syndrome on basis of downe"s score will be calculated. |