Impact of Women's Empowerment Program for Abused Pregnant... | NCT01933555

Studies
Impact of Women's Empowerment Program for Abused Pregnant Women

NCT01933555

Sponsor

Macmillan Research Group UK

Status

Completed

Last Update Posted

Sep 2, 2013Estimated

Enrollment

76Actual

Phase

Phase 2

Conditions

Abuse Physical Battered Woman Syndrome

Interventions

Empowerment Program

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jun 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Aug 28, 2013

First Submission Date that Met QC Criteria

Aug 28, 2013

First Posted Date

Sep 2, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2013

Last Update Posted Date

Sep 2, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Although domestic violence is recognized as major threat in pregnancy, there is no intervention has been developed or test to support women in India. To evaluate the effect of women's empowerment program administered to abused women in order to reduce domestic abuse, improving health status and safety behavior.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

76Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Empowerment program	Experimental	The hour intervention, delivered over a 11-week period, consisted of an empowerment and additional components adapted from Freedom program run to support domestic abused women.	Behavioral: Empowerment Program
Control group	No Intervention	Standard care, which was routine check ups and care provided by health care professionals.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Empowerment Program	Behavioral		Empowerment program

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of life(Sf-36)		Five Months

Secondary Outcomes

Measure	Description	Time Frame
Post natal depression		5 months

Other Outcomes

Measure	Description	Time Frame
Domestic Violence Inventory and safety seeking behavior		5 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

at least 18 years of age,
victims of intimate partner violence, and
willing to participate

Exclusion Criteria:

women whose abuser was not their intimate partner or
who were unable to consent

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Neha Sharma, PhD	Macmillan research group	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NMP medical research institute		Jaipur	Rajasthan	302019	India