| CTRI Number |
CTRI/2024/06/068493 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Fetal and maternal outcome in abruptio placenta |
|
Scientific Title of Study
|
A prospective observational study of fetomaternal outcome of abruptio placenta |
| 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. Lirisha Vinodkumar Saxena |
| Designation |
1st year resident |
| Affiliation |
|
| Address |
Gopnath maternity home,Sir t hospital,Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
7265086621 |
| Fax |
|
| Email |
lirishavs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Dipti C. Parmar |
| Designation |
Associate professor |
| Affiliation |
|
| Address |
Gopnath maternity home,sir t hospital,Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9925021608 |
| Fax |
|
| Email |
kda2308@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Dipti C. Parmar |
| Designation |
Associate professor |
| Affiliation |
|
| Address |
Gopnath maternity home,sir t hospital,Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9925021608 |
| Fax |
|
| Email |
kda2308@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Gopnath maternity home,sir t hospital,Bhavnagar |
|
|
Primary Sponsor
|
| Name |
Dr Lirisha Vinodkumar Saxena |
| Address |
Gopnath maternity home
sir t hospital
Bhavnagar |
| 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 Lirisha Vinodkumar Saxena |
Sir t hospital,Bhavnagar |
Obstetrics and Gynaecology department,Gopnath maternity home
Bhavnagar
GUJARAT |
7265086621
lirishavs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
All pregnant women diagnosed to have abruptio placenta from 28 weeks of gestation.
|
|
| ExclusionCriteria |
| Details |
All pregnant women over 28 weeks of gestation who were admitted with
Placenta previa,
genital tract trauma,
lesion of genital tract
Vasa previa
Uterine rupture
Cervicitis
Carcinoma
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess maternal and perinatal outcome in the form of morbidity and mortality |
15 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate possible etiological factors of abruptio placenta
|
15 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
16/06/2024 |
| 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="3"
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
|
1st step: permission will be taken from ethical committee. 2nd step: patient presented to LR with placental abruption will be considered. 3rd step: detailed demographic,menstrual,obstetrics history taken and general,per abdominal,per speculum examination done. Reports – cbc, rbs s creat , liver function test,electrolite,PT-INR,urine routine micro,LDH ,D-Dimer,FDP,Fibrinogen will be done. 4th step: appropriate data will be taken of the cases. 5th step: appropriate test will be applied and data analysis will be done |