Obstetricians’ engagement for successful recruitment of participants in a randomized controlled trial promoting healthful fish consumption during pregnancy

Abstract

BACKGROUND AND AIM: Human biomonitoring trials depend on the voluntary participation of citizens, who donate biological samples and personal information related to the investigated chemical exposures. Pregnant women are vulnerable to exposure to mercury, a potent developmental neurotoxicant. In Europe, the primary source of exposure to mercury relates to fish consumption. At the same time, fish consumption during pregnancy provides essential nutrients for optimal fetal brain and eye development. The benefits can outweigh the risks if suitable dietary advice is provided during pregnancy. METHODS: Cyprus, a small coastal Southeastern European country, used national data of fish consumption and mercury occurrence in fish to develop the first ever recommendations for Cypriot pregnant women. These are tested in the European “HBM4EU-mom” randomized control trial (10/2020 – 12/2021, Horizon2020 Programme Contract No.733032 ) with the involvement of 130 women of 18-45 years in a healthy singleton pregnancy, willing to eat fish. 15 trained obstetricians nation-wide recruit women under their care and take their hair sample during routine pregnancy appointments. RESULTS:Within one month, 78 pregnant women, corresponding to 60% of the recruitment target, were successfully recruited and provided hair samples. Virtually all women invited to join the study, consent to participation. Some women provide their informed consent at the time of invitation, while others review the information for participants at home and return the completed certificate of informed consent at the next scheduled meeting. Based on current data, it is predicted that the recruitment target will be reached within two months total. CONCLUSIONS:Recruitment of pregnant women and sampling by obstetricians is successful because it builds on the trust that the pregnant women feel towards their health care provider. It also overcomes obstacles due to the COVID-19 pandemic, creates educational opportunities for the doctors and facilitates the communication of personal results to the participants via their health care provider. KEYWORDS: Community-engaged research, Policy, Chemical exposures, Heavy metals, Exposure assessment, Pregnancy outcomes