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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN35969343
Enrollment
500
Registered
2016-05-23
Start date
2014-03-01
Completion date
Unknown
Last updated
2022-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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 Not Applicable

Interventions

This interventional, randomized control trial will be conducted in four antenatal care settings within the public health system in Johannesburg, South Africa. Approximately n=1680 women attending rout

Sponsors

World Health Organization (Switzerland)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
Intimate partner violence (measured by the World Health Organization Multi-country Study Instrument, a 12-item self-reported tool that has been validated in multiple country settings [1]) at baseline (antenatal clinic visit) and follow-up (4-20 weeks postpartum) 1. Garcia-Moreno, C., et al., Prevalence of intimate partner violence: findings from the WHO multi-country study on women's health and domestic violence. Lancet, 2006. 368(9543): p. 1260-9.

Secondary

MeasureTime frame
Measured at baseline (antenatal clinic visit) and follow-up (4-20 weeks postpartum): 1. Mental health: Depression will be measured at baseline and follow-up. Continuous variable representing depressive symptomology, derived by summing seven items from the Hospital Anxiety and Depression Scale (HADS), a 14-item measure for assessing mental health in primary health care settings [2] that has been used in South Africa [3]. Probable depression will be defined by a cut-off of 8+ on HADS-D. 2. Mental health: Anxiety will be measured at baseline and follow-up. Continuous variable representing anxiety symptomology, derived by summing seven items from the Hospital Anxiety and Depression Scale (HADS). Probable anxiety will be defined by a cut-off of 8+ on HADS-A. 3. Self-efficacy will be measured using the Generalized Self-Efficacy Scale at baseline and follow-up. This instrument is used to assess women's perceived self-efficacy and has been shown to be a valid measure of women's coping and problem-solving when faced with stressful life events [4]. 2. Zigmond, A.S. and R. Snaith, The hospital anxiety and depression scale. Acta Psychiatrica Scandinavica, 1983. 67(6): p. 361-370. 3. Abratt, R. and G. Viljoen, Assessment of quality of life by clinicians--experience of a practical method in lung cancer patients. S Afr Med J, 1995. 85(9): p. 896-8. 4. Schwarzer, R. and M. Jerusalem, Causal and control beliefs: Generalized self-efficacy scale, in Measures in health psychology: A user’s portfolio., J. Weinman, S. Wright, and M. Johnston, Editors. 1995, NFER-NELSON: Windsor, UK. p. 35-37.

Countries

South Africa

Contacts

Public ContactAbigail Hatcher
abbeymae@email.unc.edu+27 (0)115 385 000

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 11, 2026