| CTRI Number |
CTRI/2025/05/086134 [Registered on: 01/05/2025] Trial Registered Prospectively |
| Last Modified On: |
27/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An observational study on serum lactate dehydrogenase and uric acid levels in hypertensive disorders of pregnancy and prediction of fetomaternal outcome |
|
Scientific Title of Study
|
A PROSPECTIVE OBSERVATIONAL STUDY ON SERUM LDH AND URIC ACID LEVELS IN HYPERTENSIVE DISORDERS OF PREGNANCY AND PREDICTION OF FETOMATERNAL OUTCOME |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KAVYA BASANAGOUDA NAGANAGOUDAR |
| Designation |
POST GRADUATE |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
OPD NO 2
DEPARTMENT OF OBG
BLDE SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE SOLAPUR ROAD VIJAYAPURA
OPD NO 2 DEPARTMENT OF OBG
BLDE SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE SOLAPUR ROAD VIJAYAPURA
Bijapur
KARNATAKA
586103
India |
| Phone |
09482235039 |
| Fax |
|
| Email |
k.naganagoudar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR S R MUDANUR |
| Designation |
PROFESSOR |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
OBG OPD NO 2
DEPARTMENT OF OBG
BLDE SHRI B.M.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE SOLAPUR ROAD VIJAYAPUR
OBG OPD NO 2
DEPARTMENT OF OBG
BLDE SHRI B.M.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE SOLAPUR ROAD VIJAYAPUR
Bijapur
KARNATAKA
586103
India |
| Phone |
09448820961 |
| Fax |
|
| Email |
drmudanurs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KAVYA BASANAGOUDA NAGANAGOUDAR |
| Designation |
POST GRADUATE |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
OBG OPD NO 2
DEPARTMENT OF OBG
BLDE SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE SOLAPUR ROAD VIJAYAPURA
OBG OPD NO 2
DEPARTMENT OF OBG
BLDE SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE SOLAPUR ROAD VIJAYAPURA
Bijapur
KARNATAKA
586103
India |
| Phone |
09482235039 |
| Fax |
|
| Email |
k.naganagoudar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Kavya Basanagouda Naganagoudar - OBG OPD NO 2
Department of obstetrics and gynaecology
BLDEs Shri B M Patil Medical College and hospital and research centre, Solapur road , Vijayapura |
|
|
Primary Sponsor
|
| Name |
BLDEs Shri B M Patil Medical College and hospital and research centre Solapur road Vijayapura |
| Address |
OBG OPD NO 2
Department of obstetrics and gynaecology
BLDEs Shri B M Patil Medical College and hospital and research centre, Solapur road , Vijayapura |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kavya Basanagouda Naganagoudar |
BLDE SHRI B M PATIL MEDICAL COLLEGE AND HOSPITAL RESEARCH CENTRE BIJAPUR |
OBG OPD NO 2
Department of obstetrics and gynaecology
BLDEs Shri B M Patil Medical College and hospital and research centre, Solapur road , Vijayapura
Bijapur
KARNATAKA |
9482235039
k.naganagoudar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONALETHICALCLEARANCECOMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women with period of gestational age 20 weeks with singleton pregnancy with hypertensive disorders of pregnancy
|
|
| ExclusionCriteria |
| Details |
History of medical disorders like cardiac, renal, hemolytic and liver diseases hyperurecimia and gout
Patients who refused to take part as per our protocol
Any medical or surgical disorders with deranged RFT & LFT
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To predict the feto - maternal outcome in relation to abnormal serum levels of LDH and URIC ACID in pregnant woman with hypertensive disorders of pregnancy, outcomes post delivery such as morbidity , mode of delivery , nice admission of the baby and over all well being and early discharge from the hospital
|
48 hours post delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Preventative care & prophylactic treatment can be given to patients in her better results in future pregnancy |
2 days after delivery |
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165"
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)
|
05/05/2025 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Pregnancy-related
hypertensive disorders occur in 3-5% of pregnancies significantly contributing
to maternal morbidity and mortality
·Assessing
a range of biochemical and biophysical
indicators in the initial stages of pregnancy plays a crucial role in
anticipating the occurrence of adverse outcome. Efforts have been undertaken to
co-relate these early markers with hypertensive disorders of pregnancy
associated colmplications
and flawed placentation, compromised blood flow, and dysfunction of endothelial
cells.
·Elevated
uric acid levels is an early marker associated with
hypertensive disorders of pregnancy and is detected as early as 10 weeks of
gestation •Increased
levels of uric acid suggests serious impending damage to kidney function. While
elevated concentrations of these markers are not uniformly seen in every woman
with preeclampsia, they do appear toidentify a subset of preeclamptic women
who are at greater risk for maternal and fetal morbidities, thereby suggesting
diagnostic and also prognostic significance. •Lactate
dehydrogenase (LDH) is an intracellular enzyme; thus, elevated levels are
indicative of cellular dysfunction, hemolysis,
and cell death.Hypoxia
in preeclampsia increases both glycolysis and LDH activity, resulting in higher
lactate production
Studies have shown an increased serum levels
of LDH as a predictive factor in the onset of hemolysis, elevated liver enzyme
levels, and low platelet levels (HELLP syndrome) and small for gestational age
babies NEED FOR THE STUDY: •Maternal mortality is global indicator of
National health index.
•Early detection and timely intervention
in cases of hypertensive disorders of pregnancy can decrease maternal mortality
significantly which precisely is the main objective of the study
•Another objective being determining fetal
outcomes, the study helps in closely monitoring pregnant women which leads to
better fetal
outcomes, hence achieving safe confinement.
•There are no ethical issues associated
with the study
|