| CTRI Number |
CTRI/2024/03/064851 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
25/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Fetomaternal monitoring in latent and active phase of labor to detect adverse pregnancy outcomes |
|
Scientific Title of Study
|
Fetomaternal monitoring in latent and active phase of labor to detect adverse pregnancy outcome |
| Trial Acronym |
FMMLAPL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manisha Chandel |
| Designation |
Post graduate resident |
| Affiliation |
ATAL BIHARI VAJPAYEE INSTITUTE OF MEDICAL SCIENCES AND DR RML HOSPITAL |
| Address |
Department of Obstetrics and Gynaecology
Gynae office
Maternity nursing home
DR RML HOSPITAL
Baba Kharak Singh road
Type 3 President estate
Department of Obstetrics and Gynaecology
Gynae office
Maternity nursing home
DR RML HOSPITAL
Baba Kharak Singh road
Type 3 President estate
New Delhi 110001
Central
DELHI
110001
India |
| Phone |
8076305473 |
| Fax |
|
| Email |
manishachandel268@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Kumar |
| Designation |
Director Professor & Head of Department |
| Affiliation |
ATAL BIHARI VAJPAYEE INSTITUTE OF MEDICAL SCIENCES AND DR RML HOSPITAL |
| Address |
Department of Obstetrics and Gynaecology
Gynae office
Maternity nursing home
DR RML HOSPITAL
Baba Kharak Singh road
Type 3 President estate
New Delhi 110001
Central
DELHI
110001
India |
| Phone |
9968604346 |
| Fax |
|
| Email |
ash64kr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Kumar |
| Designation |
Head of the Department and Professor |
| Affiliation |
ATAL BIHARI VAJPAYEE INSTITUTE OF MEDICAL SCIENCES AND DR RML HOSPITAL |
| Address |
Department of Obstetrics and Gynaecology
Gynae office
Maternity nursing home
DR RML HOSPITAL
Baba Kharak Singh road
Type 3 President estate
New Delhi 110001
Central
DELHI
110001
India |
| Phone |
9968604346 |
| Fax |
|
| Email |
ash64kr@yahoo.com |
|
|
Source of Monetary or Material Support
|
| ATAL BIHARI VAJPAYEE INSTITUTE OF MEDICAL SCIENCE AND DR RML HOSPITAL
Baba Kharak Singh road
Type 3 President estate
New Delhi- 110001 |
|
|
Primary Sponsor
|
| Name |
Dr Manisha Chandel |
| Address |
Department of Obstetrics and Gynaecology
Gynae office
Maternity nursing home
Dr RML HOSPITAL
Baba Kharak Singh Road
Type 3 President Estate
New Delhi 110001 |
| Type of Sponsor |
Other [Self] |
|
|
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 Manisha Chandel |
RAM MANOHAR LOHIA HOSPITAL |
RAM MANOHAR LOHIA HOSPITAL
Baba Kharak Singh Road
Type 3 President estate
New Delhi
Central
DELHI |
8076305473
manishachandel268@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee ABVIMS and DR RML HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
pregnant women between 37-41 weeks of period of gestation
live singleton pregnancy
low risk pregnancy
planned for vaginal delivery
cephalic presentation |
|
| ExclusionCriteria |
| Details |
Pregnancy with anomalous fetus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mode of delivery (emergency caesarean/ vaginal delivery) |
Just before and after delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Maternal – 1) Antepartum hemorrhage
2) Duration of latent and active phase of labour
Fetal – 1) Fetal distress (bradycardia/ tachycardia)
2) Meconium stained liquor
3) APGAR at 1 , 5 and 10 minutes
4) Admission in NICU |
before and after delivery |
|
|
Target Sample Size
|
Total Sample Size="320"
Sample Size from India="320"
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)
|
04/04/2024 |
| 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="4"
Days="29" |
|
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
|
To study the role of fetomaternal monitoring in latent and active phase of labor to detect adverse pregnancy outcomes. In this study we aim to study all the possible adverse pregnancy outcome in latent and active phase of labour by fetal and maternal monitoring.
Research Hypothesis - Fetomaternal monitoring in latent phase detects adverse pregnancy outcome. |