| CTRI Number |
CTRI/2024/11/076429 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
28/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
observational prospective study |
| Study Design |
Other |
|
Public Title of Study
|
STUDY OF PRIMARY CESAREAN DELIVERIES IN SINGLETON PREGNANCIES:MOTHER AND NEWBORN OUTCOME |
|
Scientific Title of Study
|
COMPREHENSIVE STUDY OF PRIMARY CESAREAN DELIVERIES IN SINGLETON PREGNANCIES AND ITS MATERNAL AND NEONATAL OUTCOME.
|
| Trial Acronym |
PRIMCO(primary cesarean outcomes) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R SARITHA |
| Designation |
DNB 1ST YEAR |
| Affiliation |
DR TMA PAI HOSPITAL UDUPI |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNEACOLOGY,
DR TMA PAI HOSPITAL
,NEAR COURT ROAD ,OPP TO SMART BAZAR ,UDUPI
DEPARTMENT OF OBSTETRICS AND GYNEACOLOGY,
DR TMA PAI HOSPITAL
,NEAR COURT ROAD ,OPP TO SMART BAZAR ,UDUPI
Udupi
KARNATAKA
576101
India |
| Phone |
6301398669 |
| Fax |
|
| Email |
saritharaase.26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VINUTHA |
| Designation |
Associate Professor |
| Affiliation |
DR TMA PAI HOSPITAL UDUPI |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNEACOLOGY,
DR TMA PAI HOSPITAL
,NEAR COURT ROAD ,OPP TO SMART BAZAR ,UDUPI
DEPARTMENT OF OBSTETRICS AND GYNEACOLOGY,
DR TMA PAI HOSPITAL
,NEAR COURT ROAD ,OPP TO SMART BAZAR ,UDUPI
Udupi
KARNATAKA
576101
India |
| Phone |
9739317650 |
| Fax |
|
| Email |
vinuthakvinod@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
R SARITHA |
| Designation |
DNB 1ST YEAR |
| Affiliation |
DR TMA PAI HOSPITAL UDUPI |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNEACOLOGY,
DR TMA PAI HOSPITAL
,NEAR COURT ROAD ,OPP TO SMART BAZAR ,UDUPI
DEPARTMENT OF OBSTETRICS AND GYNEACOLOGY,
DR TMA PAI HOSPITAL
,NEAR COURT ROAD ,OPP TO SMART BAZAR ,UDUPI
Udupi
KARNATAKA
576101
India |
| Phone |
6301398669 |
| Fax |
|
| Email |
saritharaase.26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Data collected from Department of obstetrics and gynecology
DR TMA PAI HOSPITAL,near court road old taluk office , udupi , karnataka 576101
India
No monetory support needed for this study |
|
|
Primary Sponsor
|
| Name |
DR R SARITHA |
| Address |
DEPARTMENT OF OBSTETRICS AND GYNEACOLOGY ,
DR TMA PAI HOSPITAL ,
UDUPI. |
| 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 R SARITHA |
DR TMA PAI HOSPITAL |
Ostetrics and Gyneacology department ,1st floor
near court road old taluk office ,oppt to smart bazar
Udupi
KARNATAKA |
6301398669
saritharaase.26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITTEE-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
pregnant women |
|
|
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 |
1.Primigravida
2.Multigravida with previous normal vaginal delivery
3.singleton pregnancies
4.patients who are delivering in DR TMA PAI Hospital udupi
5.Gestational age beyond 28 weeks
6.live births
7.consent for participation whoever is given
8.previous scar pregnancy |
|
| ExclusionCriteria |
| Details |
1.multigravida with previous cesarean section
2.multifetal pregnancies
3.fetal anomalies
4. still birth
5.lack of consent for participation
6.insufficient data |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| BY KNOWING RESULT IN THAT SAMPLE SIZE SO THAT WE CAN KNOW IN HOW MANY OF THE PATIENTS CESAREAN DELIVERY IS CAUSING COMPLICATIONS AND NICU ADMISSIONS.MY SAMPLE SIZE IS 175 |
3DAYS FROM POINT OF DELIVERY TO STAY OF MOTHER AND BABY IN THE HOSPITAL |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| we observe fetal outcome by observing the samples whether baby is getting admitted for any complications |
for 3 days after delivery we observe whether baby had any complications or not |
|
|
Target Sample Size
|
Total Sample Size="175"
Sample Size from India="175"
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)
|
10/11/2024 |
| 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="0"
Months="6"
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
|
Patients who are admitted for delivery will be followed up, patient details will be collected from anc file, mode of primary cesarean delivery will be noted, Post-delivery complications in mother and neonatal outcome will be noted by observing mother’s vitals and parameters after delivery and neonate condition in NICU.This study will help in knowing the caesarean delivery rate, indications of caesarean deliveries, maternal and fetal outcome, long term maternal and child health care utilization, analyzing quality of care indicators trends and predictional factors influencing decision making in temporal trends in cesarean section rates. |