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Clinical Trials/ISRCTN35969343
ISRCTN35969343
Completed
未知

Addressing violence against pregnant women in antenatal care: testing an intervention in South Africa

World Health Organization (Switzerland)0 sites500 target enrollmentMay 23, 2016

Overview

Phase
未知
Intervention
Not specified
Conditions
Past 12-months intimate partner violence, defined as self-reported incidence one or more times of any physical or sexual act of partner abuse
Sponsor
World Health Organization (Switzerland)
Enrollment
500
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

2016 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/27814706 protocol

Registry
who.int
Start Date
May 23, 2016
End Date
July 29, 2016
Last Updated
3 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
World Health Organization (Switzerland)

Eligibility Criteria

Inclusion Criteria

  • 1\. Age of 18 years or older
  • 2\. Less than 33 weeks gestation
  • 3\. Ability to communicate in English, Tswana, Sotho or Zulu
  • 4\. No positive response to any of the following exclusion criteria based on lethal risk:
  • 4\.1\. At immediate risk of lethal violence by a partner
  • 4\.2\. Child at immediate risk of lethal violence by her partner
  • 4\.3\. Suicidal risk (as determined by having ideation with a plan to commit suicide)
  • Furthermore, participation in the RCT is dependent on IPV status. Only women who have a positive response that they have experienced any act of physical or sexual violence by a partner in the past year on either the screening instrument or the extended WHO instrument will be eligible for randomization. IPV\-negative women can participate in the sub\-studies but not in the RCT.

Exclusion Criteria

  • Pregnant women who do not agree to be screened, enrolled and randomised, are less than 18 years of age, or who screen positive for immediate safety risk will be ineligible. These women will be recorded in a study log along with date, reason for exclusion, and nurse researcher notes on the case.

Outcomes

Primary Outcomes

Not specified

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