| CTRI Number |
CTRI/2024/04/066185 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
19/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Looking at factors that might increase the chances of having a baby born too early and having problems during childbirth and afterwards. |
|
Scientific Title of Study
|
Risk Factors Associated with Preterm Delivery and Adverse Perinatal Outcome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditi R |
| Designation |
POST GRADUATE |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Dept of OBG, Kasturba Medical College, Manipal, MAHE, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
7411811010 |
| Fax |
|
| Email |
aditiragha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aditi R |
| Designation |
POST GRADUATE |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Dept of OBG, Kasturba Medical College, Manipal, MAHE, Udupi
KARNATAKA
576104
India |
| Phone |
7411811010 |
| Fax |
|
| Email |
aditiragha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditi R |
| Designation |
POST GRADUATE |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Dept of OBG, Kasturba Medical College, Manipal, MAHE, Udupi
KARNATAKA
576104
India |
| Phone |
7411811010 |
| Fax |
|
| Email |
aditiragha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of OBG, Kasturba hospital, KMC Manipal, Udupi, Karnataka |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NA |
| Type of Sponsor |
Other [NIL] |
|
|
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 Akhila Vasudeva |
Kasturba Hospital, KMC Manipal |
Dept of OBG, KMC Manipal, Udupi, Karnataka
Udupi
KARNATAKA |
9591614792
akhila.vasudeva@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O601||Preterm labor with preterm delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
We are recruiting women who have delivered preterm so that a pre-determined set of risk factors can be acquired from their obstetric history. Appropriate number of women who have delivered term are also recruited so that the same set of risk factors are collected from them. Thus, studying their association with preterm delivery. |
|
| ExclusionCriteria |
| Details |
Those women who do not have their obstetric history available and those who are unwilling to reveal their obstetric data.Postpartum Women admitted to HDU/ICU due to critical obstetric/non-obstetric problem. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To collect comprehensive clinical data of preterm and term delivery and to correlate risk factors of preterm labor and adverse perinatal outcome |
To collect comprehensive clinical data of preterm and term delivery and to correlate risk factors of preterm labor and adverse perinatal outcome |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
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)
|
02/05/2024 |
| 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="2"
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
|
Research on preterm deliveries is crucial for several reasons. Firstly, it helps identify risk factors, allowing for early interventions to reduce the incidence of preterm births. Additionally, studying preterm deliveries contributes to advancements in medical understanding, leading to improved prenatal care and neonatal outcomes. This research also aids in developing targeted interventions for high-risk populations, ultimately enhancing maternal and child health. This study by proving the strength of association between risk factors and preterm delivery, will help in focusing interventions on specific high-risk populations, thus improving perinatal outcome. |