| CTRI Number |
CTRI/2022/03/041132 [Registered on: 16/03/2022] Trial Registered Prospectively |
| Last Modified On: |
21/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
UMBILICAL (nabhi) CORD LENGTH EFFECT ON BABY HEALTH |
|
Scientific Title of Study
|
A study on The effect of umbilical cord length on perinatal outcome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ASHIKA HAPPY |
| Designation |
POSTGRADUATE |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
Department of obstetrics and gynaecology,lok nayak hospital,new delhi
Department of obstetrics and gynaecology,lok nayak hospital,new delhi
West
DELHI
110002
India |
| Phone |
9953458692 |
| Fax |
|
| Email |
ashikamehta1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrDevender kumar |
| Designation |
consultant |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
Department of obstetrics and gynaecology,lok nayak hospital,new delhi
Department of obstetrics and gynaecology,lok nayak hospital,new delhi
West
DELHI
110002
India |
| Phone |
9953458692 |
| Fax |
|
| Email |
devendermamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ASHIKA HAPPY |
| Designation |
POSTGRADUATE |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
Department of obstetrics and gynaecology,lok nayak hospital,new delhi
Department of obstetrics and gynaecology,lok nayak hospital,new delhi
West
DELHI
110002
India |
| Phone |
9953458692 |
| Fax |
|
| Email |
ashikamehta1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of obstetrics and gynaecology,lok nayak hospital,new delhi |
|
|
Primary Sponsor
|
| Name |
MAULANA AZAD MEDICAL COLLEGELOK NAYAK HOSPITALNEW DELHI |
| Address |
Department of obstetrics and gynaecology,lok nayak 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 |
| ASHIKA HAPPY |
LOK NAYAK HOSPITAL,MAULANA AZAD MEDICAL COLLEGE,NEW DELHI |
Department of obstetrics and gynaecology,lok nayak hospital,new delhi
New Delhi
DELHI |
9953458692
ashikamehta1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,MAULANA AZAD MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PREGNANT WOMAN
|
| Patients |
(1) ICD-10 Condition: O693||Labor and delivery complicated byshort cord, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Singleton pregnancy for vaginal or cesarean delivery at 37 weeks or more. |
|
| ExclusionCriteria |
| Details |
1)Multiple gestation
2)Intrauterine fetal death
3)Lethal congenital malformation
4)Chorioamnionities
5)Preterm labor |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association of umbilical cord length(short, average or long)with fetal outcome and mode of delivery |
Association of umbilical cord length(short, average or long)with fetal outcome and mode of delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Malpresentation
2)Abruptio placenta |
1 YEAR |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
17/03/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/03/2022 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
A study on The effect of umbilical cord length on perinatal outcome |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The umbilical cord is a conduit between the fetus and placenta that delivers oxygen rich blood through umbilical vein to fetus and deoxygenated blood away from the fetus through the umbilical artery. The length and position of the umbilical cord are associated with a wide range of unfavourable perinatal outcomes. Hence this study is being done to know the effect of cord length on perinatal outcomes. This study will be conducted in deptartment of obstetrics and gynaecology , Lok NAYAK hospital, New Delhi . Study period will be 1 year .Sample size will be 300. Study population will include singleton pregnancy for vaginal or cesarean section at 37 weeks or more. Multiple gestations, intrauterine death, lethal congenital malformation, chorioamnionitis, preterm labor will be excluded. Association of umbilical cord length with fetal outcomes(live birth, birth weight, meconium stained liquor, apgar at 0,1,5 min, admission and duration in NICU) and maternal outcomes(mode of delivery) will be studied. |