| CTRI Number |
CTRI/2023/05/053267 [Registered on: 30/05/2023] Trial Registered Prospectively |
| Last Modified On: |
24/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Outcome of obstetric patients admitted in surgical ICU |
|
Scientific Title of Study
|
A STUDY OF CLINICAL CHARACTERISTICS, PREVALENCE AND OUTCOME OF OBSTETRIC PATIENTS ADMITTED TO SURGICAL INTENSIVE CARE UNIT OF TERTIARY REFERRAL CENTER |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SHIVANI THAKUR |
| Designation |
Junior Resident |
| Affiliation |
Govt. Medical College, Aurangabad |
| Address |
Department of Anesthesiology Govt. Medical College and Hospital, Aurangabad.
Panchakki Road, Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
6267731299 |
| Fax |
-- |
| Email |
shivanidsthakur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHIVANI THAKUR |
| Designation |
Junior Resident |
| Affiliation |
Govt. Medical College, Aurangabad |
| Address |
Department of Anesthesiology Govt. Medical College and Hospital, Aurangabad.
Panchakki Road, Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
6267731299 |
| Fax |
-- |
| Email |
shivanidsthakur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHIVANI THAKUR |
| Designation |
Junior Resident |
| Affiliation |
Govt. Medical College, Aurangabad |
| Address |
Department of Anesthesiology Govt. Medical College and Hospital, Aurangabad.
Panchakki Road, Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
6267731299 |
| Fax |
-- |
| Email |
shivanidsthakur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dean, Govt. Medical College and Hospital, Panchakki road, Jubili Park, Aurangabad (Maharashtra) |
|
|
Primary Sponsor
|
| Name |
Dean GMCHA |
| Address |
Govt. Medical College and Hospital, Panchakki Road, Aurangabad. |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr G V Tadwalker |
Professor & HOD, Anesthesiology GMCHA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR JOSHI S A |
Govt. Medical College and Hospital, Aurangabad. |
Dept. of Anaesthesiology, Surgical ICU
Aurangabad
MAHARASHTRA |
9422777903
--
suchita_khadke@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GMCA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, (2) ICD-10 Condition: O268||Other specified pregnancy relatedconditions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NOT APPLICABLE |
NOT APPLICABLE |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Obstetric patients admitted to surgical ICU |
|
| ExclusionCriteria |
| Details |
1.Pts developing complications before & after vaginal delivery.
2.Obstetric pts with medical complications managed at medical ICU.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The prevalence pattern, clinical characteristics and reasons for the admission of obstetric patients to the ICU |
ICU DAY 1, 2, 3, 4, 5
DISCHARGE FROM ICU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.The appropriate interventions required in ICU with their subsequent outcomes.
2.To calculate APACHE SCORE II at the time of admission |
ICU DAY 1, 2, 3, 4, 5
DISCHARGE FROM ICU |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
16/06/2023 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
The study will be published in indexed medical journal after completion |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Obstetric
admission to the ICU is an indirect indicator of maternal morbidity and
mortality. The admission rate is less
than 1% in high- income countries whereas it is as high
as 7% in India. This prospective observational study is planned to estimate the prevalence pattern,
clinical characteristics and reasons for the admission
of obstetric patients to the ICU of a tertiary
referral hospital.
Records
will be collected from case file after ICU admission & studied in detail
for demographic profile, clinical characteristics, operative notes for indications, intraopertive
findings, duration of surgery and blood loss, anaesthesia records and postoperative events. Final outcomes of the patients
will be monitor.
Data recorded in MS excel &presented as Mean (SD) or
percentage. Statistical analysis
will be done with Parametric test for continuous variable & Chi square test
for categorical data. P<0.05 considered as
statistically significant. |