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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02279368
Other study ID # Adwin006
Secondary ID
Status Completed
Phase N/A
First received October 28, 2014
Last updated October 30, 2014
Start date September 2013
Est. completion date October 2014

Study information

Verified date October 2014
Source Adwin Life Care
Contact n/a
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Interventional

Clinical Trial Summary

In Northern India, skewed sex ratios, female feticide and higher child mortality rates for girls have become serious concern. The female child mortality as a result of son preference have increased during the last several decades. Since families cannot know the sex of the fetus due to Indian government policies, they now 'neglect' girl child to ensure there are few survivors. Survival chances of second and third daughters are plunging neglecting healthcare and nutrition has become tool for death as 'good riddance'.


Recruitment information / eligibility

Status Completed
Enrollment 134
Est. completion date October 2014
Est. primary completion date May 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- Families having girl child before

- High risk families with high expectation of having son

Exclusion Criteria:

- Families having son before

- Relocation and moving out of town during study period

- Not ready to consent for intervention

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
Family Counselling and safeguarding


Locations

Country Name City State
India GyanSanjeevani Jhunjhunu Rajasthan
India Sonal Foundation Mahesana Gujarat
India Khatri educational trust Satnali Hariyana

Sponsors (4)

Lead Sponsor Collaborator
Adwin Life Care Gyaansanjeevani, Jhunjhunu, Rajasthan, India, Khatri education trust, Satnaali, Hariyana, India, Sonal Foundation, India

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Other Child survival rate (reported incidences of injuries and emergencies) Upto six weeks reported incidences of injuries and emergencies No
Primary Mother-infant interaction (Parent/Caregiver Involvement Scale) Change from Baseline in Parent/Caregiver Involvement Scale at 6 weeks No
Secondary Abuse and neglect outcomes (reported incidences of abuse and maltreatment) Upto six weeks reported incidences of abuse and maltreatment No