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CTRI Number  CTRI/2024/06/069174 [Registered on: 19/06/2024] Trial Registered Prospectively
Last Modified On: 02/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Effects of air pollution exposure in pregnant females and its correlation with pregnancy and birth outcomes 
Scientific Title of Study   Impact of Air Pollution on Pregnancy Outcomes 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhoomika Patel 
Designation  Associate Professor and Associate Dean 
Affiliation  National Forensic Sciences University, Sector 9, Gandhinagar, Gujarat 
Address  Room No. 109, School of Medico-Legal Studies, National Forensic Sciences University, Sector 9, Gandhinagar, Gujarat

Gandhinagar
GUJARAT
382007
India 
Phone  9898308973  
Fax    
Email  bhoomika.patel@nfsu.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Garvita Parikh 
Designation  Ph.D. Scholar 
Affiliation  National Forensic Sciences University, Sector 9, Gandhinagar, Gujarat 
Address  Room No. 109, School of Medico-Legal Studies, National Forensic Sciences University, Sector 9, Gandhinagar, Gujarat

Gandhinagar
GUJARAT
382007
India 
Phone  7300486304  
Fax    
Email  garvita.parikh@nfsu.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Bhoomika Patel 
Designation  Associate Professor and Associate Dean 
Affiliation  National Forensic Sciences University, Sector 9, Gandhinagar, Gujarat 
Address  Room No. 109, School of Medico-Legal Studies, National Forensic Sciences University, Sector 9, Gandhinagar, Gujarat

Gandhinagar
GUJARAT
382007
India 
Phone  9898308973  
Fax    
Email  bhoomika.patel@nfsu.ac.in  
 
Source of Monetary or Material Support  
National Forensic Sciences University, Sector 9, Gandhinagar, Gujarat, 382007. 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr AU Mehta  B.J. Medical College and Civil Hospital  D- block, Labour room, Department of Obstetrics & Gynecology, B.J. Medical College and Civil Hospital, Ahmedabad, Gujarat
Ahmadabad
GUJARAT 		 9824219496

theamiya@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethics Committee, National Forensic Sciences University, Sector 9, Gandhinagar, Gujarat, 382007  Approved 
The Institutional Ethics Committee B.J. Medical College & Civil Hospital, Ahmedabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P046||Newborn affected by maternal exposure to environmental chemical substances,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1.Pregnant women from specific selected locations.
2.Patients willing to provide Informed consent.
 
 
ExclusionCriteria 
Details  1.Pregnant via assisted reproductive technology.
2.Pregnant women before pregnancy if diagnosed with any of the following pre-existing conditions diabetes, hypertension, or thyroid disorder etc.
3.Pregnant women with pre-existing tobacco, drug, alcohol, or smoking habits will be excluded.
4.Pregnant women opting for cord blood banking
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Pregnancy Outcomes: Placental Abnormities, Intrauterine Growth restriction etc.
2. Birth Outcomes: Preterm Birth, Still Birth, Low Birth Weight, and Small for gestational Age, Birth defects, Weight of baby, Head Circumference, Apgar Score etc.
 		 At the baseline.
 
 
Secondary Outcome  
Outcome  TimePoints 
Inflammatory and Molecular Markers as well as Heavy Metal Analysis.   At the baseline. 
 
Target Sample Size   Total Sample Size="1080"
Sample Size from India="1080" 
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)   29/06/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [bhoomika.patel@nfsu.ac.in].

  6. For how long will this data be available start date provided 01-06-2024 and end date provided 31-05-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This prospective cohort study endeavors to examine the association between maternal exposure to air pollution during the gestational period and the emergence of adverse pregnancy and birth outcomes. The study site will be B.J. Medical College & Civil hospital, Ahmedabad. Based on inclusion and exclusion criteria pregnant women in the advanced stage of their third trimester, coinciding with their delivery date will be enrolled. Informed consent will be obtained from them and baseline data will be collected. Simultaneously air pollution data of various selected locations will be procured from the Central Pollution Control Board. The participating women will be divided into two groups: controlled group and exposed group based on their area of residence. The area of residence will be categorized on the basis of acceptance limit of pollutant as per National Ambient Air Quality Standards. The samples of maternal blood/cord blood will be collected before/after delivery and small placental tissue will be collected after delivery. Inflammatory, and molecular marker as well as pollutant assessment will be carried out in the biological samples for understanding the physiological reactions to pollutant exposure and its related adverse outcomes.


 
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