| CTRI Number |
CTRI/2024/05/067836 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prevalence of hypertension in pregnancy and its maternal and fetal outcomes |
|
Scientific Title of Study
|
Prevalence of hypertensive disorders in pregnancy and maternal and perinatal outcomes: an observational 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 Awindrila Pal |
| Designation |
PG Resident |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University |
| Address |
Department of Obstetrics and Gynaecology, 1st floor, Jawaharlal Nehru Medical College, KLE University, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
8597446503 |
| Fax |
|
| Email |
palawindrila@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yeshita Pujar |
| Designation |
Professor, Obstetrics and Gynaecology,JNMC,Belgaum |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University |
| Address |
Department of Obstetrics and Gynaecology, 1st floor, Jawaharlal Nehru Medical College, KLE University, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
9448142989 |
| Fax |
|
| Email |
yvpujar@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Awindrila Pal |
| Designation |
PG Resident |
| Affiliation |
Jawaharlal Nehru Medical College, KLE University |
| Address |
Department of Obstetrics and Gynaecology, 1st floor, Jawaharlal Nehru Medical College, KLE University, Belagavi.
Belgaum
KARNATAKA
590010
India |
| Phone |
8597446503 |
| Fax |
|
| Email |
palawindrila@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Dr Prabhakar Kore Hospital and Medical Research Center, Belagavi, Karnataka - 590010 , India |
|
|
Primary Sponsor
|
| Name |
Awindrila Pal |
| Address |
Room No. 311, New PG Ladies Hostel, JNMC Campus, KLE University, Nehru Nagar, Belagavi, Pin - 590010, Karnataka, India |
| 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 Awindrila Pal |
Dr Prabhakar Kore Hospital and Medical Research center, Belagavi |
G-1 floor, OBGYN Labour room,KLES Dr Prabakhar Kore Hospital,Nehru Nagar, Belgaum, Karnataka
Belgaum
KARNATAKA |
08597446503
palawindrila@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: O100||Pre-existing essential hypertension complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
All Pregnant women irrespective of gestational age with Blood Pressure more than 140/90 mmhg getting admitted to Labour room of KAHERs Dr Prabhakar Kore Hospital and Medical Research centre. |
|
| ExclusionCriteria |
| Details |
Patients who are a known case of epilepsy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of hypertensive disorders in pregnancy |
42 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Maternal and perinatal outcomes |
40 weeks of gestation |
|
|
Target Sample Size
|
Total Sample Size="215"
Sample Size from India="215"
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)
|
10/06/2024 |
| 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 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
|
All pregnant women irrespective of gestational age getting admitted to labour room of KAHER’S Dr Prabhakar Kore Hospital and Medical Research Centre, Belagavi who satisfy the inclusion criteria will be recruited in the study. With the approval of the Ethical committee written informed consent will be taken from all the participants enrolled for the study. Maternal and perinatal outcomes will be assessed for them. |