Effectiveness of Structured Antenatal genetic counselling in promoting informed choices in Pregnancy:A Randomised Control Trial

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.