| CTRI Number |
CTRI/2024/01/062111 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Conventional |
| Study Design |
Other |
|
Public Title of Study
|
Association of lateral location of placenta with development of high blood pressure in pregnancy |
|
Scientific Title of Study
|
Association of lateral location of placenta with development of pre-eflampsia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushmitha |
| Designation |
First year pg resident |
| Affiliation |
Government medical College Bhavnagar |
| Address |
Gopnath maternal home, sir t hospital, Bhavnagar, gujrat
Gopnath maternity home, sir t hospital BHAVNAGAR, gujrat
Bhavnagar
GUJARAT
364001
India |
| Phone |
9663760429 |
| Fax |
|
| Email |
sushmithahavaldar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajni Parikh |
| Designation |
Associate professor |
| Affiliation |
Associate professor |
| Address |
Gopnath maternity home,
Sir T Hospital,
Bhavnagar
Gopnath maternity home,
Sir T Hospital,
Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9408967969 |
| Fax |
|
| Email |
rajnimaulik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sushmitha |
| Designation |
First year pg resident |
| Affiliation |
Government medical College Bhavnagar |
| Address |
Gopnath maternity home,
Sir T Hospital,
Bhavnagar
Gopnath maternity home,
Sir T Hospital,
Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9663760429 |
| Fax |
|
| Email |
sushmithahavaldar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gopnath maternity home,
Sir T Hospital,
Bhavnagar |
|
|
Primary Sponsor
|
| Name |
self |
| Address |
room no;201
pg3 building
sir t campus, Bhavnagar |
| Type of Sponsor |
Other [self sponsor] |
|
|
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 |
| SUSHMITHA |
GOPNATH MATERNITY HOME |
Department of obstetrics and gynaecology unit 3and 4 Gopnath maternity home
GOVERNMENT MEDICAL COLLEGE, BHAVNAGAR
Bhavnagar
GUJARAT |
9663760429
sushmithahavaldar@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: O149||Unspecified pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Antenatal women belonging to 18-24 weeks of gestation with singleton pregnancy will be included in the study
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria
Women with chronic hypertension,
k/c/oDiabetes mellitus,
k/c/o Renal disease,
Severe anaemia,
k/c/oThyrotoxicosis,Gestational diabetes mellitus
Rh negative pregnancy
k/c/oImmunoinflammatory disease
k/c/o vascular disease
Patients with hemorrhagic disorders
k/c/o TORCH infections
Low-lying placenta |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess association of lateral location of placenta with development of pre-eclampsia |
At the end of 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO ASSESS ANY OBSTETRICS COMPLICATION ASSOCIATED WITH DEVELOPMENT OF PRE-ECLAMPSIA |
AT END OF 18 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "130"
Final Enrollment numbers achieved (India)="130" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pre-eclampsia is thought to be a major cause of maternal and perinatal morbidity and mortality. The majority of deaths related to pre-eclampsia can be prevented by providing timely and effective care to pregnant women presenting with such complications.Worldwide about 76,000 pregnant women die each year from pre-eclampsia and its complication. This study may help to predict development of Pre-eclampsia in those with lateral placenta if any association is found relating to this. |