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Article History

Received: 14 August 2019

Accepted: 21 November 2019

First Online: 6 January 2020

Ethics approval and consent to participate

: The study has been approved by the Human Research Ethics Committee (Medical) of the University of the Witwatersrand, South Africa (M181915) and the Medical Advisory Committee of CHBH who oversee adherence to the study protocol. Both mothers and fathers provide written informed consent. The participants provide written consent for the publication of group results from the study. Participants will be given a numerical identifier and all personal information will remain confidential.Because the participants are initially screened through the Foetal Medicine Unit at CHBH, the study team envisage minimal risk to the pregnant women (or fetuses) and infants. However, any indications of negative effects or complications will be actioned swiftly. If it is thought that the woman or her baby may have a health problem (physical or mental), or if any changes or abnormalities are detected at a study visit, the participants will be referred to a trained nurse at the DPHRU research site who will make further enquiries, provide participants and facilitate the necessary referrals to CHBH departments. A senior clinician from CHBH is included in the investigator team who will assist in ensuring swift referral, management and follow-up of women enrolled in the study at the hospital. Women or their partners requiring psychological support will be referred to an onsite professional nurse at the research site for further assessment and counselling. There is an established network of referral bodies within the public health sector and supporting NGOs for further management. Research staff will enquire about any incidents or changes since a participant’s last visit and these will be documented and actioned, if needed. Any adverse effects as a result of the trial will be reported to the ethical committee, and participants will be referred to the clinical services provided at CHBH.Any modifications to the protocol will be communicated to the funders and the ethical committees. In addition, the Trial Advisory Committee for this study consists of leading international researchers and clinicians in the fields of maternal and child health, as well as mental health, who will play a direct role in the oversight and monitoring of the study procedures and progress.

: Not applicable.

: The authors declare that they have no competing interests.