| CTRI Number |
CTRI/2024/05/068128 [Registered on: 30/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prediction of Severe Maternal Morbidity Using Obstetric Morbidity Index- A One-year cross sectional study |
|
Scientific Title of Study
|
Prediction of Severe Maternal Morbidity Using Obstetric Morbidity Index- A One-year cross sectional study at KAHER’s Dr Prabhakar Kore Hospital And Medical Research Centre,Belagavi |
| 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 Mansi Jain |
| Designation |
PG Resident |
| Affiliation |
Jawaharlal Nehru Medical College KLE University, Belagavi |
| Address |
Department of Obstetrics and Gynaecology
Jawaharlal Nehru Medical College
KLE University, Belagavi
Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
8105228432 |
| Fax |
|
| Email |
mansijain100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Dalal |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College KLE University, Belagavi |
| Address |
Department of Obstetrics and Gynaecology
Jawaharlal Nehru Medical College
KLE University, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9448140343 |
| Fax |
|
| Email |
anitamgan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mansi Jain |
| Designation |
PG Resident |
| Affiliation |
Jawaharlal Nehru Medical College KLE University, Belagavi |
| Address |
Department of Obstetrics and Gynaecology
Jawaharlal Nehru Medical College
KLE University, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8105228432 |
| Fax |
|
| Email |
mansijain100@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER’s Dr Prabhakar Kore Hospital and Medical Research Centre
Belagavi- 590010
Karnataka
India |
|
|
Primary Sponsor
|
| Name |
Dr Mansi Jain |
| Address |
Room No BLBR2,
Akkamahadevi Girls Hostel
JNMC campus
Nehru Nagar
Belagavi |
| 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 Mansi Jain |
Dr Prabhakar Kore Hospital and Medical Research Centre, Belagavi |
G-1 floor, Labour room
Department of obstetrics and gynaecology
Dr Prabhakar Kore hospital and medical research centre
Belgaum
KARNATAKA |
8105228432
mansijain100@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: O998||Other specified diseases and conditions complicating 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 |
45.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant woman who will come to the labour room at KAHER’S Dr Prabhakar Kore Hospital and Medical Research Centre, Nehru Nagar, Belagavi |
|
| ExclusionCriteria |
| Details |
Pregnant women who do not give consent.
Critically ill patients (Some cases of morbidity which reflect the underlying health of the women, therefore thus are unavoidable) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the predictive ability of obstetric morbidity index in identifying pregnant women with co-morbidities who will be at risk of severe maternal morbidity |
42 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="800"
Sample Size from India="800"
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)
|
15/06/2024 |
| 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
|
- Maternal mortality is a result of complications that occur during and following pregnancy and childbirth, most of which are preventable or treatable. The major complications that occur for nearly 75% of all maternal deaths are: Severe bleeding (mostly after childbirth), infections, preeclampsia and eclampsia, complications from delivery and unsafe abortion.
- To prevent these complications and focusing on mothers whose clinical comorbidities lead to Severe Maternal Morbidity (SMM), it is important to have a tool that summarizes the burden of maternal comorbidities into a single number and holds promise as a maternal risk assessment tool. Obstetric comorbidity index is one such scoring system that measures each comorbidity and distills it into a single score for analysis.
- Maternal and obstetric comorbidities are given points, which are added together to create a single numerical score.
- The need for this study is to identify females with co- morbidities and assigning them a comorbidity index score to predict the risk of severe maternal morbidity like an end organ damage and mortality, at labor or a delivery.‘The Obstetric comorbidity index’ can prospectively identify the women at risk of severe maternal Morbidity in a clinical setting as it can integrate multiple compounding comorbidities and can highlight the cumulative risk associated with patient’s conditions. Therefore, routinely using this score can potentially identify at risk women who require increased surveillance and targeted care to prevent adverse maternal outcomes.
STUDY PROTOCOL - After obtaining the approval from ethical committee and a written informed consent from all the study participants, Pregnant woman with gestation age equal to or more than 28 weeks coming to labor room and delivering at KAHERs Dr Prabhakar Kore Hospital and Medical Research Centre will be included in the study.
- A predesigned and structured questionnaire will be used to collect data. After an informed consent, Obstetric comorbidity index will be calculated for each patient based on their history, examination and investigation. Any severe maternal morbidity experienced by patients till the time of discharge will be recorded and immediate outcome of the baby will be recorded. The data will be entered into an MS Excel sheet- Master Chart will be prepared. Analysis will be done based on association between the Obstetric Morbidity index score and occurrence of Severe maternal morbidity.
|