Cripe 2010.

Methods	RCT. 2‐arm trial with individual randomisation.
Participants	Setting:  public hospital in Lima, Peru, providing services to low‐income women living in Lima. Recruitment in 2007.  Inclusion criteria: 220 pregnant women (gestational age between 12 and 26 weeks’ gestation) attending for care in the study hospital who screened positive for DV on the modified Abuse Assessment screen and able to speak and understand Spanish. (Women screened positive if they said yes to any of the following in the past year – been pushed, shoved, slapped, hit, kicked or otherwise physically hurt or been forced into sexual activity by a former or current partner.)
Interventions	Experimental intervention: (110 randomised) empowerment intervention during pregnancy which included standard care (a card with information about agencies providing IPV support). Women in the empowerment intervention received supportive counselling and education, and advice in the areas of safety by a trained social worker lasting about 30 minutes. Interviewers listened empathetically to the women and acknowledged their perceptions and feelings. Interviewers also helped women understand the cycle of violence and reviewed components of the safety plan including behaviours indicated in the Safety Behavior Checklist. For example, women were asked how they might secure and hide money and important documents such as birth certificates. Interviewers helped women develop a code to use with family and trusted friends to signal the need for assistance and/or to mentally plan their escape when needed. Women were given a brochure with a 13‐item safety plan to reinforce safety behaviours. To make the safety plan brochure less conspicuous, other prenatal brochures on topics such as breastfeeding or nutrition were also offered to the women. Interviewers also provided a list of community resources, such as emergency shelter, legal aid, law enforcement, and counselling, and strategies for seeking help from these resources. As part of the intervention, interviewers also offered to assist women with telephone calls to social service agencies or women's groups who could act as advocates for abused women. At the conclusion of the empowerment intervention session, interviewers helped women determine if it was safe for her to keep the safety plan brochure and the referral card. Women were free to discuss the pros and cons of leaving the abuser, reporting the abuser to law enforcement, or applying for a protection order.   Control/Comparison intervention: (110 randomised) women randomised to receive standard care received a wallet‐size referral card listing agencies that provide DV services to abused women (e.g., legal, social services,and law enforcement). No counselling, advocacy, education, or other services were offered to women in this group during pregnancy. However, they were provided the empowerment intervention, specifically supportive counselling and education, and advice in the areas of safety by a trained social worker at the conclusion of the study during the 6th week postpartum visit.
Outcomes	Physical, functional and emotional functioning at follow‐up as compared with baseline. Use of community resources and safety behaviours. Episodes of violence in the past year were reported at baseline but data on this outcome were not reported at follow‐up.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Assignment was by a “randomised block design” but how the sequence was generated and block size were not stated.
Allocation concealment (selection bias)	Unclear risk	Methods used to allocate women to groups at the point of randomisation were not described.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Sixteen women (7.3%) were lost to follow‐up. 220 women were randomised and follow‐up data were available for 204.
Selective reporting (reporting bias)	Unclear risk	Episodes of violence at follow‐up were not reported in this paper  (it may be that these outcomes will be addressed in future papers).
Other bias	Low risk	Groups were reported to be similar at baseline and there was no other bias apparent.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Women and staff would be aware of the purpose of the study and which group they were assigned to. Post‐intervention interviews were carried out by a different interviewer than those who carried out the pre‐intervention ones to reduce bias. It was not clear what impact lack of blinding would have on the outcomes reported.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Women and staff would be aware of the purpose of the study and which group they were assigned to. Post‐intervention interviews were carried out by a different interviewer than those who carried out the pre‐intervention ones to reduce bias. It was not clear what impact lack of blinding would have on the outcomes reported.