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CTRI Number  CTRI/2025/12/098537 [Registered on: 05/12/2025] Trial Registered Prospectively
Last Modified On: 04/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Other (Specify) [Genetic counselling in ANC]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Providing Clear Genetic Information to Expectant Mothers to Support Their Pregnancy Decisions 
Scientific Title of Study   Effectiveness of Structured Antenatal genetic counselling in promoting informed choices in Pregnancy:A Randomised Control Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vijay Lal Meena 
Designation  Junior resident, family Medicine 
Affiliation  AIIMS JODHPUR 
Address  Department of Paediatrics,All India Institute Of Medical Sciences Jodhpur,2nd Floor ,Administrative Block, Basni phase 2,Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  8905133462  
Fax    
Email  gojosaturo96412@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kuldeep Singh 
Designation  Professor and head,Department of Paediatrics  
Affiliation  AIIMS JODHPUR  
Address  Department of paediatrics,All India Institute of Medical Sciences,Jodhpur,Basni Phase 2,Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  8003996940  
Fax    
Email  kulpra@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kuldeep Singh 
Designation  Professor and head,Department of Paediatrics  
Affiliation  AIIMS JODHPUR  
Address  Department of paediatrics,All India Institute of Medical Sciences,Jodhpur,Basni Phase 2,Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  8003996940  
Fax    
Email  kulpra@gmail.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF MEDICAL SCIENCES,BASNI PHASE 2,JODHPUR,RAJASTHAN,INDIA, PIN CODE-342005  
 
Primary Sponsor  
Name  Dr Vijay Lal Meena 
Address  ALL INDIA INSTITUTE OF MEDICAL SCIENCES,BASNI PHASE 2,JODHPUR,RAJASTHAN,INDIA, PIN CODE-342005  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kuldeep Singh  AIIMS,Jodhpur,Genetics OPD  All India Institute Of Medical Sciences,Basni phase 2,Jodhpur,Rajasthan,India, PIN Code-342005
Jodhpur
RAJASTHAN 		 8003996940

kulpra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Clinical Trial)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Antenatal genetic counselling in Promoting informed choices in pregnancy  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Recieve Routine Genetic Counselling Group  Recieve Routine Genetic Counselling in antenatal visits maximum till 20 weeks of period of gestation  
Intervention  Recieve Structured Genetic Counselling Group  Recieve Structured Genetic Counselling in Antenatal visits maximum till 20 weeks of period of gestation  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Pregnant women in their first or second trimester.Referred for antenatal care or genetic counselling.Willing to participate and provide written informed consent.Able to comprehend the counselling session and complete questionnaires. 
 
ExclusionCriteria 
Details  High risk pregnancies requiring immediate clinical nterventions.Presance of pre existing psychiatric illness affecting communication or desicion making.Women who have already recieved structured genetic counselling elsewhere.Unwilling or unable to follow up assessment. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
This study focuses on the outcomes such as changes in knowledge, awareness, and informed decisionmaking after structured counseling to evaluate the baseline knowledge and attitudes of pregnant women
toward genetic disorders and prenatal testing to compare the effectiveness of structured counseling with
routine antenatal counseling to evaluate the psychological impact (anxiety and decisional conflict) and
satisfaction with structured genetic counseling 		 18 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   24/12/2025 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Title of study is “EFFECTIVENESS OF STRUCTURED ANTENATAL GENETIC COUNSELLING IN
PROMOTING INFORMED CHOICES IN PREGNANCY.”

Population: Pregnant women in their first or second trimester(below 20 weeks POG), aged
18 years or above, referred for antenatal care or genetic counseling, willing to participate and
provide written informed consent, able to comprehend the counseling session and complete
questionnaires

Intervention: Receives structured genetic counselling

Comparison: Receives routine genetic counselling

Outcome:
 Primary Objective: To assess changes in knowledge, awareness, and informed decision-making
after structured counseling.

 Secondary Objectives:
1. To evaluate the baseline knowledge and attitudes of pregnant women toward genetic disorders and
prenatal testing.
2. To compare the effectiveness of structured counseling with routine antenatal counseling.
3. To evaluate the psychological impact (anxiety and decisional conflict) and satisfaction with
structured genetic counseling.

Timeframe: After IEC clearance to December 2026

Research Question:
Does structured antenatal genetic counseling increase awareness and knowledge of genetic testing
and disorders and enhance confidence in making informed reproductive choice?

Aim:
To assess the effectiveness of structured antenatal genetic counseling in promoting informed choices
among pregnant women.

Objectives:
 To assess changes in knowledge, awareness, and informed decision-making after structured counsel
ing to evaluate the baseline knowledge and attitudes of pregnant women toward genetic disorders and prenatal
testing to compare the effectiveness of structured counseling with routine antenatal counseling to evaluate the
psychological impact (anxiety and decisional conflict) and satisfaction with structured genetic counseling.

Inclusion Criteria:
Pregnant women in their first or second trimester(Less than 20 weeks POG) with age 18 years or above referred for
antenatal care or genetic counseling who are willing to participate and provide written informed consent and
able to comprehend the counseling session and complete questionnaires.

Exclusion Criteria:
High-risk pregnancies requiring immediate clinical intervention, presence of pre-existing psychiatric illness
affecting communication or decision-making, women who have already received structured genetic
counseling elsewhere, unwilling or unable to complete the follow-up assessments.

Detailed methodology: 
 Study Design: Randomized Controlled Trial (RCT) 
 Study Setting: Departments of Pediatrics and Obstetrics & Gynecology, AIIMS Jodhpur
  Study Duration: 2 years (2025 to 2027)
  Study Site: Antenatal outpatient clinic and Genetic Counseling Clinic 
 Study Population: Pregnant women referred for antenatal care or suspected/confirmed genetic disorders• Intervention Group: Will receive structured antenatal genetic counseling from trained experts
 Control Group: Will receive routine antenatal counseling as per hospital standard care

Expected Outcomes:
This study focuses on the outcomes such as changes in knowledge, awareness, and informed decisionmaking after structured counseling to evaluate the baseline knowledge and attitudes of pregnant women
toward genetic disorders and prenatal testing to compare the effectiveness of structured counseling with
routine antenatal counseling to evaluate the psychological impact (anxiety and decisional conflict) and
satisfaction with structured genetic counseling.
 
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