- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02279368
Nursing Led Interdisciplinary Intervention in Prevention of Girl Child Mortality and Maltreatment
October 30, 2014 updated by: Adwin Life Care
Nursing Led Interdisciplinary Intervention in Prevention of Girl Child Mortality and Maltreatment: Randomized Controlled Trial
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'.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
134
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gujarat
-
Mahesana, Gujarat, India
- Sonal Foundation
-
-
Hariyana
-
Satnali, Hariyana, India
- Khatri educational trust
-
-
Rajasthan
-
Jhunjhunu, Rajasthan, India, 302019
- Gyansanjeevani
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Nurses delivered the supportive intervention along with family counselling from last term of pregnancy through three months and then were followed till the first birthday of the child.
|
|
|
No Intervention: Control Group
Control group families were followed in usual care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mother-infant interaction (Parent/Caregiver Involvement Scale)
Time Frame: Change from Baseline in Parent/Caregiver Involvement Scale at 6 weeks
|
Change from Baseline in Parent/Caregiver Involvement Scale at 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Abuse and neglect outcomes (reported incidences of abuse and maltreatment)
Time Frame: Upto six weeks reported incidences of abuse and maltreatment
|
Upto six weeks reported incidences of abuse and maltreatment
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Child survival rate (reported incidences of injuries and emergencies)
Time Frame: Upto six weeks reported incidences of injuries and emergencies
|
Upto six weeks reported incidences of injuries and emergencies
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Alpesh Barot, MA, Sonal Foundation, India
- Study Director: Valerie Murray, MA, Macmillan research group
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
October 28, 2014
First Submitted That Met QC Criteria
October 30, 2014
First Posted (Estimate)
October 31, 2014
Study Record Updates
Last Update Posted (Estimate)
October 31, 2014
Last Update Submitted That Met QC Criteria
October 30, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- Adwin006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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