| CTRI Number |
CTRI/2021/11/038318 [Registered on: 29/11/2021] Trial Registered Prospectively |
| Last Modified On: |
26/11/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Chnages in the placenta due to COVID 19 infection during pregnancy |
|
Scientific Title of Study
|
Placental changes in relation to SARS-Cov2 infection in pregnancy |
| Trial Acronym |
PRSAP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anu Anna George |
| Designation |
Assistant Professor |
| Affiliation |
MOSC Medical College Hospital |
| Address |
Dept. Of Obstetrics and Gynecology
Ernakulam
KERALA
682311
India |
| Phone |
09539748095 |
| Fax |
|
| Email |
annamed013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anu Anna George |
| Designation |
Assistant Professor |
| Affiliation |
MOSC Medical College Hospital |
| Address |
Dept. Obstetrics and Gynecology
Ernakulam
KERALA
682311
India |
| Phone |
09539748095 |
| Fax |
|
| Email |
annamed013@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anu Anna George |
| Designation |
Assistant Professor |
| Affiliation |
MOSC Medical College Hospital |
| Address |
Dept. Of Obstetrics and Gynecology
Ernakulam
KERALA
682311
India |
| Phone |
09539748095 |
| Fax |
|
| Email |
annamed013@gmail.com |
|
|
Source of Monetary or Material Support
|
| MOSC Medical College Hospital
Kolenchery 682311
Ernakulam Kerala |
|
|
Primary Sponsor
|
| Name |
MOSC Medical College |
| Address |
Kolenchery
682311 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Anu Anna George |
MOSC Medical College Hospital |
Out patient unit and labour room in the Dept. of Obstetrics
HPE room in the Dept of Pathology
Ernakulam
KERALA |
04847155555
annamed013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, (2) ICD-10 Condition: U071||COVID 19 virus identified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. All mothers who were found to be Covid positive anytime during pregnancy
2. Mothers consenting to send their placenta for histopathological examination |
|
| ExclusionCriteria |
| Details |
1. History of other viral infections during pregnancy
2. Mothers diagnosed with preeclampsia or gestational hypertension or IUGR before the COVID infection
3. Those with pregestational diabetes, chronic hypertension and a history of thrombophilia.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
presence of maternal fetal vascular malperfusion in the placenta
|
at delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| maternal complications |
21 days of infection
at delivery |
| Neonatal complications |
7 days of age |
|
|
Target Sample Size
|
Total Sample Size="118"
Sample Size from India="118"
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)
|
13/12/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
With the COVID-19 pandemic at hand and with more
pregnant women being infected with the SARS CoV2 virus, the potential of
vertical transmission is still debatable.
We propose to conduct a study to analyse the pathological changes in the
placenta as a result of infection during pregnancy in comparison to Covid Negative mothers. We also aim to develop a profile of changes in
the placenta when affected by the disease. We will be conducting a
retrospective study and collecting data from the COVID positive mothers that have
delivered at our institute from October 2020. All cases of
SARS CoV2 infection will be analysed over the period of one year and cases
satisfying the selection criteria will have their pathological findings
compared with findings in normal placentas. We have estimated a sample size of
59 in a group using data from a previous study on the prevalence of
chorangiosis in COVID positive placentas. At the end of the study, we hope to
ascertain the changes in the placenta due to COVID 19 infection which in turn could
help in the obstetric management of these patients. |