| CTRI Number |
CTRI/2021/05/033458 [Registered on: 07/05/2021] Trial Registered Prospectively |
| Last Modified On: |
06/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective |
| Study Design |
Other |
|
Public Title of Study
|
Correlation between ultrasound scan findings and abnormalities of placenta in high risk pregnancy |
|
Scientific Title of Study
|
Correlation of Biophysical and Histopathological findings of placenta in high risk
pregnancy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pranavi Dasari |
| Designation |
|
| Affiliation |
Kmc manipal |
| Address |
Ground floor ,Room No 1,OBGYN department,kasturba Hospital Manipal udupi
Udupi
KARNATAKA
576104
India |
| Phone |
09491624540 |
| Fax |
|
| Email |
pranavi.1dasari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pranavi Dasari |
| Designation |
|
| Affiliation |
Kmc manipal |
| Address |
Room no 1,Ground floor,OBGYN department,Kasturba Hospital,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9491624540 |
| Fax |
|
| Email |
pranavi.1dasari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pranavi Dasari |
| Designation |
|
| Affiliation |
Kmc manipal |
| Address |
Room no 1,Ground floor,OBGYN department ,Kasturba Hospital Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09491624540 |
| Fax |
|
| Email |
pranavi.1dasari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital,Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
KMC Manipal,Udupi,Hebri road,576104 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pranavi |
Kasturba hospital Manipal |
OBGYN department,OPD block,ground floor,Room no 1
Udupi
KARNATAKA |
09491624540
pranavi.1dasari@gmail.com |
|
|
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: O099||Supervision of high risk pregnancy, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Women with the below mentioned criteria
1)Hypertensive disorders of pregnancy
2)chronic Hypertension
3)Gestational Diabetes Mellitus and Pre existing Diabetes Mellitus
4)Intra uterine Growth Restriction
5)Antepartum hemorrhage
6)Recurrent pregnancy loss
7)Abnormal placenta
8)Still birth
9)2nd time preterm premature rupture of membranes
10)In vitro fertilization pregnancies with complications
|
|
| ExclusionCriteria |
| Details |
1)Multifetal gestations
2)singleton pregnancies with no associated co morbidities
3)High risk pregnancies with gestational age <28 weeks
4)Those who refuse the placental examination
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perinatal outcomes like type of delivery,Birth weight of baby,Still birth,Intra uterine Death,APGAR score |
High risk pregnancies more than 28 weeks until postpartum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Histopathological changes of placenta |
High risk pregnancies more than 28 weeks until post partum |
|
|
Target Sample Size
|
Total Sample Size="145"
Sample Size from India="145"
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)
|
14/05/2021 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Informed consent will be obtained from all the participants The study will recruit 145 pregnant women with gestational age > 28 weeks who fit into high risk pregnancy category(as mentioned under inclusion criteria). Demographic details of the patient like maternal age, gestational age, parity will be taken Ultrasound with color doppler done between 28-36 weeks period of Gestation will be noted with focus on Middle Cerebral Artery and Umbilical Artery Immediately after delivery,the placenta will be sent to the Department of Pathology for gross and histopathological examination (as per consultant’s recommendation) Mode of delivery,Delivery outcomes and baby’s health condition will be noted. The Ultrasound changes in placenta will be studied and correlated with the histopathological changes in placenta and the perinatal outcomes.
|