| CTRI Number |
CTRI/2023/07/054602 [Registered on: 03/07/2023] Trial Registered Prospectively |
| Last Modified On: |
30/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Analysis of Hypertensive Disorders of Pregnancy in ICU |
|
Scientific Title of Study
|
Prospective Observational study of morbidity and mortality in post caesarean operated obstetric patients admitted in ICU with or without Hypertensive disorders of pregnancy |
| 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 SANJANA PATIL |
| Designation |
JUNIOR RESIDENT DOCTOR |
| Affiliation |
Lokmanya tilak municipal medical college and general hospital , Sion, |
| Address |
Department of Anaesthesiology,4th floor , room no 3, college building,
Lokmanya tilak municipal medical college and general hospital , Sion,
Mumbai 400022
Department of Anaesthesiology,4th floor , room no 3, college building,
Lokmanya tilak municipal medical college and general hospital , Sion,
Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9167398352 |
| Fax |
|
| Email |
sanjanapatil616@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr JYOTI MAGAR |
| Designation |
PROFESSOR IN DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
Lokmanya tilak municipal medical college, Sion |
| Address |
Department of anaesthesiology ,room no 3,college building, Lokmanya tilak municipal medical college, SION,Mumbai 400022
Department of anaesthesiology ,room no 3,college building, Lokmanya tilak municipal medical college, SION,Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9833706466 |
| Fax |
|
| Email |
jyotimagar2110@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SANJANA PATIL |
| Designation |
JUNIOR RESIDENT DOCTOR |
| Affiliation |
Lokmanya tilak municipal medical college,Sion |
| Address |
Department of Anaesthesiology, room no 3,college building ,Lokmanya tilak municipal medical college,Sion mumbai 400022
Department of Anaesthesiology, room no 3,college building ,Lokmanya tilak municipal medical college,Sion mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9167398352 |
| Fax |
|
| Email |
sanjanapatil616@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lokmanya Tilak Municipal College and Hospital sion west Mumbai 400022 |
|
|
Primary Sponsor
|
| Name |
Lokmanya Tilak Municipal College and Hospital sion west Mumbai 400022 |
| Address |
Lokmanya Tilak Municipal College and Hospital sion west Mumbai 400022 |
| 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 Sanjana Patil |
Lokmanya Tilak Municipal College |
Department of Anaesthesiology, Lokmanya Tilak Municipal College and Hospital sion west Mumbai 400022
Mumbai
MAHARASHTRA |
9167398352
sanjanapatil616@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE HUMAN RESEARCH LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL |
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, (2) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, (3) ICD-10 Condition: O099||Supervision of high risk pregnancy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
All caesarean operated obstetric patients admitted in ICU postoperative within 6 weeks of termination of pregnancy will be enrolled in the study |
|
| ExclusionCriteria |
| Details |
Any Obstetric patients who did not undergo cesarean delivery or not admitted to ICU will not be included in this study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary objectives: Comparison of post caesarean operated obstetric patients with & without Hypertensive disorders of pregnancy with respect to :
1.Indication of admission to ICU
2.Morbidity with respect to organ dysfunction
3.Morbidity with respect to critical intervention
4.Mortality |
Upto 6 weeks post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Objective: To find association of factors in post caesarean operated patients admitted to ICU with Hypertensive disorders of pregnancy with 1. Maternal morbidity,
2. Maternal mortality |
42 day post caesarean section |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/07/2023 |
| 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
|
Despite advances in obstetric care, Hypertensive disorders of pregnancy (HDP), particularly preeclampsia/ eclampsia , remains one of the leading causes of maternal morbidity and mortality worldwide. HDP occur in 5 - 10 % of pregnancies account for nearly 18% of all maternal deaths worldwide. The World Health Organization estimates that at least one woman dies every 7 min from the complications of Hypertensive disorder of pregnancy. In India, HDP accounts for the third most important cause of maternal mortality. The pregnant woman is usually young and in good health before she becomes critically ill; hence, her prognosis will be better if she receives timely intensive care intervention. Quite often, the Intensive Care Unit (ICU) intervention becomes necessary for the treatment of hypertensive disorder of pregnancy particularly, preeclampsia/eclampsia for the management of associated complications but even then HDP is the leading cause maternal death in developed but more so developing country. Primary prevention of HDP and its complications is not always possible. Many a times delivery is only option to reduce maternal as well as perinatal morbidity and mortality .Caesarean section is preferred mode of delivery. Thus anesthetist plays a major role not only in perioperative management of HDP women coming Caesarean section but also in their critical care in postoperative ICU as delivery only initiates the recovery but it is not a cure . The rising incidence of HDP-related deaths makes it necessary to identify the causes of such mortalities and provide this information to healthcare providers to protect these mothers from death in an intensive care unit. However, there are very few data specifically concerning HDP patients transferred to intensive care unit. Thus we decided undertake this study to compare Caesarean operated obstetric patients admitted in ICU with and without HDP with respect to morbidity and mortality and to compare factors to identify predictors of maternal morbidity & mortality in HDP |