| CTRI Number |
CTRI/2025/11/097493 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding placental blood flow patterns and its effect on birth outcomes . |
|
Scientific Title of Study
|
Role of cerebroplacental ratio for perinatal outcomes in low-risk, early term pregnancy |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohd Aftab |
| Designation |
PG Resident |
| Affiliation |
Dr RML Hospital |
| Address |
Department of Obstetrics and Gynaecology
Department of Obstetrics and Gynaecology
Central
DELHI
110001
India |
| Phone |
9596980054 |
| Fax |
|
| Email |
dr.aftabch62@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Kumar |
| Designation |
Director and Head |
| Affiliation |
Dr RML Hospital |
| Address |
MNH, Deptt. of Obstetrics and Gynaecology
Director office, Dr RML Hospital
Central
DELHI
110001
India |
| Phone |
9968604346 |
| Fax |
|
| Email |
ash64kr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamna Datta |
| Designation |
Professor |
| Affiliation |
Dr RML Hospital |
| Address |
MNH , Department of Obstetrics and Gynaecology
MNH
Central
DELHI
110001
India |
| Phone |
9891145329 |
| Fax |
|
| Email |
kamnadatta29@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Aftab |
| Address |
Dr RML Hospital
Deptt. of obstetrics and gynaecology |
| Type of Sponsor |
Other [Dr Aftab ] |
|
|
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 |
| Mohd Aftab |
Dr RML Hospital |
Department of obstetrics and gynaecology
Central
DELHI |
9596980054
dr.aftabch62@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No Complications |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Low risk primigravida with singleton live pregnancy between 37wks to 38+6weeks POG with appropriate for gestational age fetus. |
|
| ExclusionCriteria |
| Details |
Fetal anomalies
Maternal complications (e.g. hypertension in pregnancy , hyprerglycemia in pregnancy , Polyhydramnios , Oligohydramnios ,Anemia etc)
History of chronic diseases like chronic liver disease, chronic respiratory disease, chronic renal disease etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| FHR abnormality |
During Labour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
GESTATIONAL AGE AT THE TIME OF DELIVERY
MECONIUM STAINED LIQUOR
PLACENTAL ABRUPTION
MODE OF DELIVERY
APGAR
NICU ADMISSION
NEED FOR RESUSCITATION
OCCURRENCE OF RDS
PERINATAL MORTALITY AND
MORBIDITY |
At the time of delivery |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
25/11/2025 |
| 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="5"
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 consecutive pregnant women between 37 to 38+6 weeks with singleton live fetus will be evaluated by history taking and examination as per the attached proforma. The patients will be recruited according to the inclusion and exclusion criteria after obtaining their written consent regarding their willingness to be a part of the study.
Obstetrics ultrasound Doppler will be performed at the time of recruitment, including biometry, CPR, fetal weight and AFI to be measured. Patients will be categorized into SGA , AGA, and LGA. The pregnant women with AGA will be followed up till delivery. Intrapartum maternal and fetal monitoring will be done and the pregnancy outcomes will be recorded as follows :
Primary Outcomes – FHR abnormality
Secondary Outcomes – Meconium-stained liquor , Placental Abruption, Mode of delivery, Birth weight, APGAR, NICU admission (If yes- how many days), Need for Resuscitation, Occurrence of RDS, Perinatal mortality and morbidity, Gestational age at the time of delivery.
Role of cerebroplaental ratio for perinatal outcomes in low-risk, early term pregnancy will be analysed with statistical analysis.
|