| CTRI Number |
CTRI/2025/11/097515 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparision of the risk factors which will cause high BP readings and complications of high BP readings in pregnancy between normal BP pregnant lady and the high BP pregnant lady |
|
Scientific Title of Study
|
Correlation of onset of preeclampsia in hypertensive disorders in pregnancy, admitted for delivery by FOGSI HDP-Gestosis score in a tertiary care hospital: a case control 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 |
Manoj TP |
| Designation |
MBBS, Post Graduate in MS Obstetrics and Gynaecology |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi |
| Address |
TARUR AT POST, SIRA TALUK,
TUMAKURU DISTRICT
Department of Obstetrics and Gynaecology,
KLES Dr Prabhakar Kore Hospital and Medical Research Centre,
JNMC, Belagavi
Belgaum
KARNATAKA
572125
India |
| Phone |
9663998447 |
| Fax |
|
| Email |
manoj2000manu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shruthi Andola |
| Designation |
Associate professor |
| Affiliation |
KLES Dr Prabhakar Kore Hospital and Medical Research Centre, JNMC, Belagavi |
| Address |
Department of Obstetrics and Gynaecology,
KLES Dr Prabhakar Kore Hospital and Medical Research Centre,
JNMC, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7760710689 |
| Fax |
|
| Email |
shrutiandola@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruthi Andola |
| Designation |
Associate professor |
| Affiliation |
KLES Dr Prabhakar Kore Hospital and Medical Research Centre, JNMC, Belagavi |
| Address |
Department of Obstetrics and Gynaecology,
KLES Dr Prabhakar Kore Hospital and Medical Research Centre,
JNMC, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7760710689 |
| Fax |
|
| Email |
shrutiandola@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manoj TP |
| Address |
Jawaharlal Nehru Medical College, Belagavi- 590010, Karnataka |
| 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 |
| Manoj TP |
KLES Dr Prabhakar Kore Hospital and Medical Research Centre, JNMC Belagavi |
G-1 floor, Labour room
Department of Obstetrics and Gynaecology,
JNMC, Nehru Nagar, Belagavi-590010
KLES Dr Prabhakar Kore Hospital and Medical Research Centre,
JNMC, Belagavi
Belgaum
KARNATAKA |
09663998447
manoj2000manu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Comittee |
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
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Antenatal women diagnosed with hypertensive disorders in pregnancy whether presenting with blood pressure readings more than or equal to 140 by 90 mmHg at the time of admission for delivery or those already on antihypertensive medications with controlled blood pressure less than 140 by 90 mmHg will be included as cases upon admission to the labor room
Antenatal women with normal Blood Pressure admitted for delivery will be taken as controls
Patients who are willing to give consents will be included
|
|
| ExclusionCriteria |
| Details |
• Any women admitted for delivery in the labor room and are not willing to give consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • To assess the correlation using FOGSI[Federation of Obstetrics and Gynecological societies of India] HDP-Gestosis score for development of preeclampsia in patients with hypertensive disorders in pregnancy versus normotensive women. |
28 weeks to 42 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To evaluate the feto-maternal outcomes in Hypertensive diseases in pregnancy (HDP). |
28 weeks to 42 weeks |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
30/11/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
HDPGestosis score is a simplified dynamic feasible quantification of
maternal clinical risk factors for effective screening of Hypertensive
Disorders in Pregnancy HDP gestosis score is a high risk scoring system score 1 to 3 for the development of preeclampsia
Hypertensive disorders in pregnancy are
the spectrum of disorders ranging from already existing chronic hypertension in
the index pregnancy to complex multisystem disorder like preeclampsia leading
to the complications like eclampsia HELLP syndrome Acute renal failure Pulmonary edema Stroke and Left ventricular failure Severe preeclampsia and
these complications are the major causes of maternal and perinatal morbidity
and mortality Among all maternal deaths 19 percent of deaths are due to hypertension in
pregnancy despite the phenomenal numbers of patients seeking
hospital based delivery care substantial gap is identified in the quality of
care executed
Primary objective
To assess the
correlation using FOGSI Federation of Obstetrics and Gynecological societies of
India HDP Gestosis score for
development of preeclampsia in patients with hypertensive disorders in
pregnancy versus normotensive women
Secondary objective To evaluate
the fetomaternal outcomes in Hypertensive diseases in pregnancy HDP Inclusion Criteria ·
Antenatal women presenting with hypertensive disorders in pregnancy
with blood pressure recordings more than or equal to 140 by 90 mmHg at the time of admission for
delivery or those already on antihypertensive medications with or without controlled
blood pressure 140 by 90 mmHg will be included as cases upon admission ·
At the same time antenatal women
with normal Blood Pressure admitted for delivery will be taken as controls ·
Patients who are willing to give
consents will be included Exclusion Criteria ·
Any women admitted for delivery in
the labor room and are not willing to give consent Data collection procedure ·
Permission from the institutional
ethics committee and the university clearance will be taken ·
Meeting and the rapport building
with the study participants ·
200 women with Hypertensive
disorders in pregnancy whose BP readings are more than or equal to 140 by 90 mmHg admitted in labor
room for delivery will be enrolled as cases into the study and 200 women
admitting and delivering during same period and found to have normal BP
readings will be enrolled as controls ·
The patients are provided with the
study information sheet and consent form and will be explained about the
relevant details about the study in a language best understood by them ·
Informed written consent will be
obtained after explaining about the purpose nature and process of the study
and then data collection will be started ·
The detailed history and through
physical and obstetric examination along with the relevant investigations will
be done risk factors if any will be noted ·
The information pertaining to the
study such as age parity gravida residence family history and BMI details will
be obtained from the patients ·
Routine antenatal investigations
will be collected from the patients by their case records Apart from the
routine antenatal investigations this study necessitates serum lipid profile
for scoring hence the sample for the lipid profile will be collected ·
History of pre gestational and
gestational diabetes mellitus chronic hypertension mental disease chronic
kidney disease history of HDP in previous pregnancy and history of diagnosed
autoimmune disease like SLE or APLA syndrome MAP thrombophilia will be
collected during their admission to the labor room for delivery ·
Antenatal and intranatal details
will be noted ·
Maternal and fetal monitoring will
be performed as per standard guidelines
Maternal and fetal outcomes in terms of
morbidity and mortality will be noted
|