| CTRI Number |
CTRI/2025/10/096010 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
13/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Mothers in Crisis: A Year of Intensive Care for Pregnancy-Related Complications |
|
Scientific Title of Study
|
Maternal outcomes of antenatal and postpartum women admitted to an Intensive Care Unit a one year cross sectional tertiary care hospital based 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 |
Varsha Prabhu |
| Designation |
MBBS, Postgraduate in Obstetrics and Gynecology |
| Affiliation |
Jawaharlal Medical College , Belagavi |
| Address |
G-1 Labour room
Department of Obstetrics and Gynecology
KLEs Dr Prabhakar Kore Hospital and Medical Research centre, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7022924724 |
| Fax |
|
| Email |
varshaprabhu100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kamal Patil |
| Designation |
Professor Obstetrics and Gynecology , JNMC |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi |
| Address |
GURUPRIYA, 2nd main, 2nd cross, Sadashiv Nagar
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7022924724 |
| Fax |
|
| Email |
kamalpatil1967@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Varsha Prabhu |
| Designation |
MBBS, Postgraduate in Obstetrics and Gynecology |
| Affiliation |
Jawaharlal Medical College , Belagavi |
| Address |
G-1 Labour room
Department of Obstetrics and Gynecology
KLEs Dr Prabhakar Kore Hospital and Medical Research centre, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7022924724 |
| Fax |
|
| Email |
varshaprabhu100@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. KLEs Prabhakar Kore Hospital
Belagavi - 590010
Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Varsha Prabhu |
| Address |
Jawaharlal Nehru Medical College, Belagavi-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 Varsha Prabhu |
KLE Dr. Prabhakar Kore Hospital and Medical Research centre, JNMC Belagavi |
G-1 Labour room
Department of Obstetrics and Gynecology
KLEs Dr Prabhakar Kore Hospital and Medical Research centre, Belagavi
Belgaum
KARNATAKA |
07022924724
varshaprabhu100@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: O098||Supervision of other high risk pregnancies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
All Obstetric patients both antenatal and postnatal admitted to the Intensive Care Unit ICU (Cardiac, Medical, Surgical, Liver)
During pregnancy
During delivery
Within 42 days postpartum
|
|
| ExclusionCriteria |
| Details |
Obstetric Patients who are
Vitally stable
Admitted to high dependency unit (HDU)
Admitted to the labour room
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Objective - To study the maternal morbidity and mortality of antenatal and postpartum women admitted to the Intensive Care Unit (ICU)
|
6 weeks of gestation till 42 days postpartum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Objective - To analyse the relationship of the level of delay, indications of ICU admissions, interventions done and fetal outcome with the maternal outcomes.
|
6 weeks of gestation till 42 days postpartum. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
24/10/2025 |
| 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
|
Introduction :Maternal mortality remains a
pressing global public health challenge.
Identifying
women at risk is of paramount importance
Severe Acute Maternal
Morbidity
(SAMM) or Near-miss mortality is more common than maternal
mortality and is defined as a woman who nearly died but survived a
complication
that occurred during pregnancy or within 42 days postpartum International targets under
the Sustainable Development
Goals aim to reduce the global maternal mortality ratio to less than 70
per 100,000 live births
by
2030 Need for the study: Early
recognition of
high-risk obstetric patients is crucial for timely intervention, and
effective ICU management
which can significantly reduce adverse outcomes.
Its a growing need to analyse and
understand the reasons for ICU admissions in obstetric populations to
improve clinical
decision-making, allocate resources effectively and implement
strategies for early risk
identification. Data
collection procedure:
After admission to the ICU, a
detailed history has to be taken from relatives of the patient and also details
extracted from available medical records.
Basic demographic details of patients, like age,
parity, literacy level, socioeconomic status, and level of delay of the patient,
are recorded.
Labour details such as gestational
age, obstetric score, Booked or unbooked case, ANC visits, cause of ICU
admission, duration of ICU Stay, vaginal delivery or cesarean section or any
instrumental delivery, antepartum/intrapartum/postpartum complication leading
to ICU Admissions will be noted
|