| CTRI Number |
CTRI/2026/02/104627 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A Observational Study to Understand How Meconium-Stained Amniotic Fluid Affects Mothers and Babies During Delivery |
|
Scientific Title of Study
|
A single centre prospective observational study aimed at evaluating fetomaternal outcome in meconium stained liquor and identifying maternal factors associated with meconium stained liquor |
| 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 YOGINI PATIL |
| Designation |
Head of Obsterics and Gynaecology Department |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
Opd no 3, Ground floor, Dept of Obs and Gynae, Bhaktivedanta Swami Marg , Sector 6 , Shristi Complex, Mira road east, Thane, Maharashtra
Thane
MAHARASHTRA
401107
India |
| Phone |
9322498480 |
| Fax |
|
| Email |
dryoginippatil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR YOGINI PATIL |
| Designation |
HEAD OF OBSTETRICS AND GYNAECOLOGY DEPARTMENT |
| Affiliation |
BHAKTIVEDANTA HOSPITAL AND RESEARCH INSTITUDE |
| Address |
Opd no 3, Ground floor, Dept of Obs and Gynae, Bhaktivedanta Swami Marg , Sector 6 , Shristi Complex, Mira road east, Thane, Maharashtra
Opd no 3, Ground floor, Dept of Obs and Gynae, Bhaktivedanta Swami Marg , Sector 6 , Shristi Complex, Mira road east, Thane, Maharashtra
Thane
MAHARASHTRA
401107
India |
| Phone |
9322498480 |
| Fax |
|
| Email |
dryoginippatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR YOGINI PATIL |
| Designation |
Head of Obstetrics and Gynacology Department |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
Opd no 3, Ground floor, Dept of Obs and Gynae, Bhaktivedanta Swami Marg , Sector 6 , Shristi Complex, Mira road east, Thane, Maharashtra
Thane
MAHARASHTRA
401107
India |
| Phone |
9322498480 |
| Fax |
|
| Email |
dryoginippatil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhaktivedanta hospital and Research institute,Shristi complex, Bhaktivedanta Swami marg, Mira road east, Thane-401107 |
|
|
Primary Sponsor
|
| Name |
Bhaktivedanta hospital and Research institute |
| Address |
Shristi complex, Bhaktivedanta Swami marg, Mira road east, Thane-401107 |
| 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 Aleena Ahmad |
Bhaktivedanta hospital and Research institute |
Opd no 3, Ground floor, Dept of Obs and Gynae, Bhaktivedanta Swami Marg , Sector 6 , Shristi Complex, Mira road east, Thane, Maharashtra
Thane
MAHARASHTRA |
7715870125
draleenaahmad98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhaktivedanta Hospital Ethics Committee for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Pregnant women at term with spontaneous or induced labour
2. Presence of meconium stained amniotic fluid noted during labour or at rupture of membranes
3. Singleton pregnancy with cephalic presentation
4.Willingness to give informed written consent |
|
| ExclusionCriteria |
| Details |
1. Multiple pregnancies
2. Congenital anomalies detected antenatally or at birth
3. Intrauterine fetal demise
4. Women not consenting to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of neonatal outcome
1. meconium aspiration syndrome
2. birth asphyxia
3. NICU admissions
4. Neontal mortality
Maternal outcome such as-puerperal complications |
Patients will be monitored during the process of labour.
They will be monitored at admission in labour- if membranes have ruptured.
if membranes are intact-they will be reassessed when membranes rupture-spontaneously or artificially.
Routine check-on subsequent PV examinations- every 4 hourly in active labour or early if indicated.
Fetal outcome-will be monitored at birth, first hour post delivery, first 24 hours to check for respiratory distress and finally before discharge. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Identification of maternal factors associated with MSL
1. Maternal age
2. Parity
3. Gestational age at delivery
4 Duration of labour
5. Postdatism
6. Oligohydramnios
7. IUGR
8. Induction of labour
|
these factors will be assessed antenatally-noted 1 hour after admission. |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
10/03/2026 |
| 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="2"
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
|
All pregnant women admitted to the labour room of the Department of the Obstetrics and Gynaecology at bhaktivedanta hospital, mumbai during the study period will be screened for eligibility. Those found to have meconium stained amniotic fluid , eithe on spontaneous or artificial rupture of membranes will be enrolled after informed written consent. For each participant , relevant maternal details including age, parity, gestational age and obstetric history will be recorded. The consistency of meconium will be noted and classified as thin or thick. Progress of labour, mode of delivery and any intrapartum interventions or complications will be documented. After delivery , the newborn will be assessed for APGAR scores at 1 and 5 minutes, need for resuscitation, development of meconium aspiration syndrome, NICU admissions and development of perinatal mortality. maternal outcomes such as duration of hospital say, post partum hemorrhage, infections and need for ICU care will be rcorded.All data will be systematically entered into structured case record form. |