| CTRI Number |
CTRI/2022/02/040021 [Registered on: 04/02/2022] Trial Registered Prospectively |
| Last Modified On: |
04/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Observational study of cardiac evaluation in normal Pregnancy. |
|
Scientific Title of Study
|
Normal Pregnancy And Cardiac Evaluation (N-PACE) Study |
| Trial Acronym |
N-PACE Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Justin Paul G |
| Designation |
Professor of Cardiology |
| Affiliation |
Madras Medical College |
| Address |
Madras Medical College,
EVR Salai, Park Town, Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
91-9840071558 |
| Fax |
|
| Email |
drjpheart@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Justin Paul G |
| Designation |
Professor of Cardiology |
| Affiliation |
Madras Medical College |
| Address |
Madras Medical College,
EVR Salai, Park Town, Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
91-9840071558 |
| Fax |
|
| Email |
drjpheart@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Justin Paul G |
| Designation |
Professor of Cardiology |
| Affiliation |
Madras Medical College |
| Address |
Madras Medical College,
EVR Salai, Park Town, Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
91-9840071558 |
| Fax |
|
| Email |
drjpheart@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madras Medical College, EVR Salai, Park Town, Chennai-600002 |
|
|
Primary Sponsor
|
| Name |
Madras Medical College |
| Address |
EVR Salai, Park Town, Chennai-600002 |
| Type of Sponsor |
Government 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 |
| Dr G Justin Paul |
Madras Medical College |
First Floor, State Program Management Unit, Institute of Cardiology, Rajiv Gandhi Government General Hospital, EVR Salai, Park Town
Chennai-600002
Chennai
TAMIL NADU |
91-9840071558
drjpheart@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy pregnant women and Healthy non pregnant women |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant Participants: Pregnant woman who comes for routine cardiac evaluation and is having an echocardiogram done as a part of routine evaluation any time from pregnancy diagnosis till hospitalisation for delivery.
2. Non Pregnant Participants: Women of child bearing age, who are referred for a cardiac evaluation who are matched in age will also be enrolled as controls
3. Willingness to the partake in the study.
|
|
| ExclusionCriteria |
| Details |
1. Those with any form of structural heart disease
2. Women with cardiac arrhythmia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cardiac Chamber size,
Ventricular Function |
at first trimester, at second trimester and third trimester |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="1500"
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)
|
10/02/2022 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drjpheart@gmail.com].
- For how long will this data be available start date provided 01-01-2024 and end date provided 01-09-2024?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Data on cardiac symptoms (shortness of breath, palpiations etc) experiecned by a pregnanct women with out heart disease in India is scarce Data on normal dimensions of the heart in Indian women during pregnancyis scarcee
This study seeks to fill the gap in the literature, by assessing these outcomes.
|