| CTRI Number |
CTRI/2024/04/066386 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A one year study of a biochemical marker in patients with increased BP readings and reduced growth of the baby and outcomes of mother and baby. |
|
Scientific Title of Study
|
Association of serum placental growth factor in pre-eclampsia and FGR with maternal and perinatal outcomes-A one year cross sectional study |
| 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 Sudhanshu Gan |
| Designation |
M.S. Obstetrics and Gynecology |
| Affiliation |
KAHERs Jawaharlal Nehru Medical College |
| Address |
Department of Obstetrics and Gynecology
Jawaharlal Nehru Medical College,
Belagavi-590010.
Belgaum
KARNATAKA
590010
India |
| Phone |
9481433874 |
| Fax |
|
| Email |
sudhanshugan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yeshita V Pujar |
| Designation |
Professor and HOD |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Obstetrics and Gynecology
Jawaharlal Nehru Medical College,
Belagavi-590010.
Belgaum
KARNATAKA
590010
India |
| Phone |
9448142988 |
| Fax |
|
| Email |
yvpujar@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yeshita V Pujar |
| Designation |
Professor and HOD |
| Affiliation |
KAHERs Jawaharlal Nehru Medical College |
| Address |
Department of Obstetrics and Gynecology
Jawaharlal Nehru Medical College,
Belagavi-590010.
Belgaum
KARNATAKA
590010
India |
| Phone |
9448142988 |
| Fax |
|
| Email |
yvpujar@hotmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs Dr Prabhakar Kore hospital and Medical Research Centre |
|
|
Primary Sponsor
|
| Name |
Dr Sudhanshu Gan |
| Address |
Jawaharlal Nehru Medical College,
Belagavi-590010
|
| 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 Sudhanshu Gan |
KLEs Dr .Prabhakar Kore Hospital and Medical Research Centre |
Department Of Obstetrics And Gynaecology
Jawaharlal Nehru Medical College, BELAGAVI- 590010
Belgaum
KARNATAKA |
9481433874
sudhanshugan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O140||Mild to moderate pre-eclampsia, |
|
|
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 with singleton pregnancy with more than 20 weeks period of gestation with a dating scan for conformation having pre eclampsia or fetal growth restriction will be included |
|
| ExclusionCriteria |
| Details |
Multiple pregnancy
Other hypertensive disorders
Renal dysfunctions
Non consenting women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the association of serum PLGF level in pregnant women with pre-eclampsia and FGR with maternal and new born outcomes |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate the PlGF level with severity of pre eclampsia & FGR |
one year |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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)
|
06/05/2024 |
| 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="0"
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
|
To study
the association of serum Placental Growth Factor level in pregnant women with pre-eclampsia and
FGR with maternal and new born outcomes and also to
correlate the Placental Growth Factor level with severity of pre-eclampsia and FGR. for this study we will include pregnant women beyond 20 weeks of gestation with confirmed dates and and having pre eclampsia or foetal growth restriction the Placental Growth Factor levels will be correlated with maternal and foetal outcomes |