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Authors
Chalise, P.
Manandhar, P.
Infanti, J. J.
Campbell, J.
Henriksen, L.
Joshi, S. K.
Koju, R.
Pun, K. D.
Rishal, P.
Simpson, M. R.
Skovlund, E.
Swahnberg, K.
Schei, B.
Lukasse, M.
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Funding
Funding for this research was provided by:
Norges Forskningsråd (301525, 301525, 301525, 301525, 301525, 301525, 301525, 301525, 301525)
NTNU Norwegian University of Science and Technology
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Article History
Received: 4 July 2023
Accepted: 4 September 2023
First Online: 15 September 2023
Declarations
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: Our study adheres to the ethical principles for medical research involving human subjects as outlined by the World Medical Association, first adopted in the Helsinki Declaration of 1964 [CitationRef removed]. Participation in the study is voluntary and written informed consent is/will be obtained from participants. In addition, we follow the recommendation set forth by the World Health Organization (WHO) regarding ethics and safety in intervention research on violence against women [CitationRef removed]. To ensure the safety and well-being of women participating in the study, we take precautions regarding their confidentiality. For example, in situations where participating women living with violence may be questioned by their family about the study, it is crucial that their involvement does not increase their risk of violence. Therefore, we provide all women with a leaflet containing information on maintaining a healthy pregnancy and guidance on when to contact the hospital. This leaflet can be shared with their family. Furthermore, each woman receives a card with contact numbers for emergency medical conditions, hospital services, ambulance and helplines available in Nepal for situations involving violence. We consider it unethical to withhold the important information from the intervention video to all women. Thus, after completing the data collection at follow-up during the women’s third trimester, we offer all women the opportunity to view the intervention video.The ADVANCE RCT has ClinicalTrial.gov identifier NCT05199935. The study protocol is approved by the Regional Committee for Medical and Health Research Ethics Mid-Norway (178092). The study has been approved by the ethics committees of Kathmandu Medical College (2211202104), Kathmandu University School of Medical Sciences (18/22) as well as the Nepal Health Research Council (2395).
: Not applicable.
: The authors declare no competing interests.
