| CTRI Number |
CTRI/2024/03/064328 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
14/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study association of decreased fetal movement at term with fetomaternal outcome |
|
Scientific Title of Study
|
Decreased fetal movement at term as a predictor of perinatal outcome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gauri Myne |
| Designation |
first year post graduate student |
| Affiliation |
Guru Gobind Singh Indraprastha University Sector - 16C, Dwarka, New Delhi - 110078 (India) |
| Address |
Department of obstetrics and gynaecology , Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9810319306 |
| Fax |
|
| Email |
gggaurimyne@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kamna Datta |
| Designation |
Associate Professor |
| Affiliation |
Guru Gobind Singh Indraprastha University Sector - 16C, Dwarka, New Delhi - 110078 (India) |
| Address |
Department of Obstetrics and Gynecology
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
|
| Fax |
|
| Email |
kamnadatta29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gauri Myne |
| Designation |
first year post graduate student |
| Affiliation |
Guru Gobind Singh Indraprastha University Sector - 16C, Dwarka, New Delhi - 110078 (India) |
| Address |
Department of Obstetrics & Gynecology Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital, New Delhi
New Delhi
DELHI
110001
India |
| Phone |
9810319306 |
| Fax |
|
| Email |
gggaurimyne@gmail.com |
|
|
Source of Monetary or Material Support
|
| Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
Department of Obstetrics and Gynecology |
| Address |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital, New 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 GAURI MYNE |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital, New Delh |
Obstetrics and Gynecology OPD (room no 10 and 15),
obstetrics and gynecology emergency in Department of Obstetrics and Gynecology
New Delhi
DELHI |
9810319306
gggaurimyne@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE , ABVIMS , Dr . RML Hospital , New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
All pregnant females admitted in hospital or coming to opd or emergency with complaint of
decrease fetal movement at term |
|
| ExclusionCriteria |
| Details |
1 Multifetal pregnancy
2 Pregnant females with psychiatric disorders
3 Intra uterine death
4 Previous cesarean section
5 Fetal congenital anomaly |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| NICU STAY ( whether the baby will have neonatal ICU admission , if yes then how many days the baby stayed in NICU |
AFTER DELIVERY ( after 37 weeks of gestation ) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Color of Liquor ,
Mode of delivery ,
Cord blood pH ,
APGAR Score ,
Birth weight |
During & after delivery |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
25/03/2024 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A Cohort study will be conducted on pregnant woman at term with a complaint of decrease
fetal movement.
The detailed history and examination will be conducted regarding decreased fetal movement
(at least for 1 day ) which will be followed by examination ,non stress test ,Biophysical score
and estimation of cerebroplacental ratio . Decision will be taken regarding termination of
pregnancy as per the hospital protocol . Mode of delivery along with the following will be noted – color of liquor , cord blood pH ,
APGAR score at 1 min and 5 min , birth weight , NICU stay .
Umblical cord will be clamped using 3 cord clamps , 2 clamps will go towards baby and 1
clamp will go towards placenta . Blood will be taken from in between the cord clamps which
are toward the fetal side. Umblical cord blood will be taken and approximately 0.5 to 1 ml
blood is taken for ph.
APGAR score will be calculated based on the following parameters - color of the baby , heart
rate , reflex irritability , muscle tone and respiration . Each parameter will get a score of 0 , 1
or 2
The neonate shall be followed till discharge.
If admitted in NICU following shall be recorded.
1. Diagnosis
2. Length of stay
3. Outcome – discharge / death
|