| CTRI Number |
CTRI/2024/05/067242 [Registered on: 13/05/2024] Trial Registered Prospectively |
| Last Modified On: |
17/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of two methods in assessing maternal outcomes among high risk pregnant women |
|
Scientific Title of Study
|
A Prospective observational study to compare the maternal outcomes between Modified Early Obstetrics Warning System (MEOWS) and Standard of care groups among high risk pregnant women |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Taiyaba Fatma |
| Designation |
Post Graduate |
| Affiliation |
Jawaharlal Nehru Medical College, KLE |
| Address |
Department of Obstetrics and Gynaecology,Jawaharlal Nehru Medical College, KLE Dr. Prabhakar Kore Hospital, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9873275080 |
| Fax |
|
| Email |
taiyaba.fatma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamal Patil |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College, KLE |
| Address |
Department of Obstetrics and Gynaecology,Jawaharlal Nehru Medical College, KLE Dr. Prabhakar Kore Hospital, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9845565454 |
| Fax |
|
| Email |
kamalpatil1967@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamal Patil |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College, KLE |
| Address |
Department of Obstetrics and Gynaecology,Jawaharlal Nehru Medical College, KLE Dr. Prabhakar Kore Hospital, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9845565454 |
| Fax |
|
| Email |
kamalpatil1967@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Taiyaba Fatma, Department of Obstetrics and Gynaecology, Dr Prabhakar Kore Hospital, Belgaum |
|
Primary Sponsor
Modification(s)
|
| Name |
Taiyaba Fatma |
| Address |
Jawaharlal Nehru Medical College, KLE Dr Prabhakar Kore Hospital, Belgaum, Karnataka 590010 |
| 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 |
| DrTaiyaba Fatma |
KLE’s Dr Prabhakar Kore Hospital, Belagavi |
Department for Obstetrics and Gynaecology, Jawaharlal Nehru Medical College, KLE Hospital, Nehru Nagar , Belagavi , Karnataka
Belgaum
KARNATAKA |
9873275080
taiyaba.fatma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee , Jawaharlal Nehru Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.High risk pregnant women admitted in labour room
2.Antepartum women after 28 weeks of gestational age
3.High risk postpartum women upto 42 days |
|
| ExclusionCriteria |
| Details |
1. Women in active labour
2.Women who had uncomplicated normal delivery and cesarean section
3.Women who will be admitted directly to ICU
4.Non consenting women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the adverse maternal outcome between Modified Early Obstetrics Warning System (MEOWS) and Standard of care groups among high risk pregnant women |
The study will be conducted over a span of one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To estimate the prevalence of high risk pregnant women in this facility. |
The study will be conducted over a span of one year. |
|
|
Target Sample Size
|
Total Sample Size="642"
Sample Size from India="642"
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)
|
20/05/2024 |
| 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
|
Maternal mortality is still a major concern for health system worldwide.
Analyses of maternal deaths have consistently revealed that delay in the recognition of pregnancy complications are associated with higher mortality. Therefore, Early warning system was proposed to reduce maternal mortality and morbidity.
MEOWS involve the routine monitoring and recording of vital signs or clinical observations on specifically designed charts with linked escalation protocols. They list criteria for abnormal physiological parameters that trigger a colour coded or weighted scoring system aimed to guide the frequency of monitoring, need for, and urgency of clinical review.
The study aims at evaluating the use of MEOWS score as a simple bedside tool and establish its use in predicting maternal mortality and morbidity. It emphasises the importance of early recognition of deterioration of apparently sick patients, ensures better communication within members of multidisciplinary team, and providing prompt attention to the unwell women.
This study aims at comparing the maternal outcomes between two groups- First group include those women who will be monitored using MEOWS chart and the others monitored as a routine monitoring system. |