| CTRI Number |
CTRI/2024/07/070180 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
07/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Detecting congenital anomalies that are missed in 5th month anomaly scan |
|
Scientific Title of Study
|
Prevalence Of Congenital Fetal Anomalies Detected On Third Trimester
Ultrasound And At Birth - A Cross Sectional 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 |
Mahasweta Das |
| Designation |
Post Graduate in MS Obstetrics and Gynaecology |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi |
| Address |
OPD -10
Department of OBG
KLE University, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8431229969 |
| Fax |
|
| Email |
mahasweta29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MB Bellad |
| Designation |
Professor, Department Of Obstetrics and Gynaecology, JNMC, Belagavi |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi |
| Address |
G-1 Floor, Labour Room, Department Of Obstetrics And Gynaecology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, JNMC, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9448124893 |
| Fax |
|
| Email |
mbbellad@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MB Bellad |
| Designation |
Professor, Department Of Obstetrics and Gynaecology, JNMC, Belagavi |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi |
| Address |
G-1 Floor, Labour Room, Department Of Obstetrics And Gynaecology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, JNMC, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9448124893 |
| Fax |
|
| Email |
mbbellad@hotmail.com |
|
|
Source of Monetary or Material Support
|
| KLES Dr Prabhakar Kore Hospital and Medical Research Centre, JNMC , Belagavi - 590010
India |
|
|
Primary Sponsor
|
| Name |
Mahasweta Das |
| Address |
Jawaharlal Nehru Medical College, Belagavi- 590010, Karnataka |
| 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 Mahasweta Das |
KLES Dr Prabhakar Kore Hospital and Medical Research Centre, JNMC |
G-1 Floor, Labour Room, Department Of Obstetrics And Gynaecology, KLES Dr Prabhakar Kore Hospital and Medical Research Centre, JNMC, Belagavi
Belgaum
KARNATAKA |
8431229969
mahasweta29@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: Q89||Other congenital malformations, not elsewhere classified, |
|
|
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 |
1. All pregnant women with more than 28weeks period of gestation who come for third
trimester growth scan to KAHER’S Dr. Prabhakar Kore Hospital.
2. Pregnancies resulting in live birth or still birth at KAHER’S Dr. Prabhakar Kore Hospital |
|
| ExclusionCriteria |
| Details |
1. Those with known structural/chromosomal abnormality detected on previous anomaly scan |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find out the prevalence of evolving fetal congenital anomalies detected on third
trimester ultrasound and at birth. |
28 weeks to 42 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
22/07/2024 |
| 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 Yet Recruiting |
| 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 Congenital anomalies are a major public health problem. As per the World Health Organization (WHO) congenital anomalies are defined as structural or functional anomalies,including metabolic disorders, present at the time of birth.Congenital anomalies occur during intrauterine life which can be detected prenatally, at birth or in later stages of life. Congenital anomalies can be subdivided into- minor and major anomalies. Minor anomalies are structural abnormality present at birth whereas, major congenital anomalies are severe enough to reduce life expectancy or may lead to difficulty in survival or result in still birth/infant death.(2) Congenital anomalies have been a major cause of neonatal and infant morbidity and mortality.As per World Health Organization, an estimate of 2,40,000 newborns die worldwide within 4 weeks of life every year due to congenital disorders.According to findings from different reviewed literature, the prevalence of congenital anomalies vary from country to country. Its is reported as 3% in the United States, 2.5% in Egypt, 2.5% in India, 2-3 % in United Kingdoms,1.07% in Japan and 4.3% in Taiwan.(7)
Need for the study Fetal anomalies can be incidentally found at a third trimester ultrasound.This scenario can occur either because it was undiagnosed during the previous scans or the phenotypic expression of the abnormality becomes apparent only after 20 weeks, such as short limbs in the case of achondroplasia, dilated bowel in the case of bowel atresia or abnormal shape of the head in the case of craniosynostosis or the abnormality develops only in the third trimester, such as ovarian cyst in response to maternal estrogenic stimulation or ventriculomegaly following fetal brain hemorrhage or maternal infection. In many setting, third trimester ultrasound is not done and these abnormalities can remain undetected till birth. Many a times even after ultrasound being done at all three trimesters, some congenital anomalies remain undetected until birth and presents for the first time at birth. The need for the study is to find out the prevalence of evolving congenital anomalies detected for the first time on third trimester ultrasound and at birth
Study protocol: All pregnant women who are more than 28 weeks coming to KAHER’S Dr. Prabhakar Kore Hospital for third trimester ultrasound or those delivering babies at KAHER’S Dr. Prabhakar Kore Hospital will be included in the study. After obtaining the approval from the Ethical committee and a waiver of consent, subjects will be recruited according to the inclusion and exclusion criteria. The patients who satisfy the inclusion criteria and do not fall under the exclusion criteria will be recruited in the study.
Data collection procedure: All the pregnant women who are more than 28 weeks coming to KAHER’S Dr. Prabhakar Kore Hospital for third trimester ultrasound and those delivering babies at KAHER’S Dr. Prabhakar Kore Hospital will be included in the study. After obtaining the approval from the Ethical committee and a waiver of consent, subjects will be recruited according to the inclusion and exclusion criteria. Screening of all the women > 28 weeks who come for antenatal check up to KAHER’S Dr. Prabhakar Kore Hospital and women coming to deliver at KAHER’S Dr. Prabhakar Kore Hospital will be done from the medical records. The women with congenital anomalies detected for the first time in a third trimester ultrasound and women delivering neonates with congenital anomalies detected for the first time at birth, their detailed relevant history and data will be collected from the medical records |