| CTRI Number |
CTRI/2024/10/076049 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
27/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To study relationship of serum LDH levels with mother and baby outcome in preeclampsia eclampsia patients |
|
Scientific Title of Study
|
A Study of relationship of serum lactate dehydrogenase levels with maternal and perinatal outcome in preeclampsia eclampsia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muskan |
| Designation |
Junior resident |
| Affiliation |
Guru Gobind Singh medical college and hospital Faridkot, punjab, india |
| Address |
Department of Obstetrics and Gynaecology Guru Gobind Singh Medical College, Faridkot, Punjab
151203
India
Faridkot
PUNJAB
151203
India |
| Phone |
9416153126 |
| Fax |
|
| Email |
Muskangarg858@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Seema Grover |
| Designation |
Professor and Head of department |
| Affiliation |
Guru Gobind Singh Medical College and Hospital Faridkot |
| Address |
Department of Obstetrics and Gynaecology Guru Gobind Singh Medical College, Faridkot, Punjab
Faridkot
PUNJAB
151203
India |
| Phone |
9417974348 |
| Fax |
|
| Email |
Groverseema@ggsmch.org |
|
Details of Contact Person
Public Query
|
| Name |
Seema Grover |
| Designation |
Professor and Head of department |
| Affiliation |
Guru Gobind Singh Medical College and Hospital Faridkot |
| Address |
Department of Obstetrics and Gynaecology Guru Gobind Singh Medical College, Faridkot, Punjab
Faridkot
PUNJAB
151203
India |
| Phone |
9417974348 |
| Fax |
|
| Email |
Groverseema@ggsmch.org |
|
|
Source of Monetary or Material Support
|
| Guru Gobind Singh Medical college Hospital, faridkot, Punjab , India
Pincode- 151203 |
|
|
Primary Sponsor
|
| Name |
Guru Gobind Singh Medical College Hospital |
| Address |
Department of Obstetrics and Gynaecology, Guru Gobind Singh Medical College Hospital, Faridkot , Punjab, India
Pincode- 151203 |
| 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 Muskan |
Guru Gobind Singh Medical College Hospital |
Department of Obstetrics and Gynaecology, Guru Gobind Singh Medical College Hospital
Faridkot
PUNJAB |
9416153126
Muskangarg858@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Guru Gobind Singh Medical College |
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 |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Antenatal preeclamptic and eclamptic women with singleton pregnancy and gestational age more than 28weeks |
|
| ExclusionCriteria |
| Details |
Antenatal women with pre pregnancy hypertension and taking hepatotoxic drugs
Antenatal women with hemolytic anemia, liver disease, malignancy and coronary artery disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To establish a relationship of serum lactate dehydogenase levels with maternal and perinatal outcome in patients of peeclampsia eclampsia |
outcome will be assessed at the end of one and half year of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To establish a relationship of serum lactate dehydrogenase levels with severity of disease in patients of preeclampsia eclampsia |
outcome will be assessed at the end of one and half year of study |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/11/2024 |
| 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="6"
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
|
Preeclampsia is one of the commonest and most dreaded compilcations of pregnancy. It is third most common cause of maternal mortality. LDH is an intracellular cytoplasmic enzyme and levels of LDH increase in preeclampsia due to cellular death and hemolysis. So, it is a useful biochemical marker to evaluate severity of preeclampsia . The analysis of LDH may enrich the ability to predict and prevent preeclampsia in near future. This can further help in making decision regarding the management strategies to improve maternal and fetal outcome in preeclampsia. Aims and objectives : To measure serum LDH levels in patients of preeclampsia and to establish a relationship of serum LDH with fetomaternal outcome and severity of disease.
A prospective study will be conducted in GGS medical college and hospital , faridkot on 90 preeclamptic and eclamptic antenatal women with gestational age 28 weeks onwards with singleton pregnancy who will be admitted and delivered in our institute.
Detailed history of patients, symptoms and complications of preeclampsia will be analyzed. Serum LDH levels will be estimated. All maternal complications, fetal outcome, gestational age at birth, APGAR score, birth weight and requirement of NICU admission will be analysed. |