Cobas b 101 point of care system

All women in the HUMBA trial are requested to have an OGTT at 26–28 weeks. The second assessment visit is scheduled after the OGTT at approximately 28–30 weeks. Weight, mid-arm circumference and BP are measured. The food frequency, physical activity questionnaires and a fetal movement questionnaire are completed by the participant. The fetal movement questionnaire is adopted from a previous study [64 ]. An updated medical history is obtained by the research midwife. The OGTT results are reported to the research team with fasting, one- and two-hour results enabling a diagnosis of GDM by the International Association of Diabetes in Pregnancy Study Groups (IADPSG) criteria [65 ]. The maternity care provider receives fasting and two-hour glucose results from the OGTT as per usual clinical practice using the New Zealand Society for the Study of Diabetes (NZSSD) criteria [66 ]. Women diagnosed with GDM by the NZSSD criteria will be referred by their maternity care provider to the Diabetes in Pregnancy Service (as per usual practice) and managed according to local guidelines including postpartum testing.
HbA1c and lipid concentrations are measured by finger prick using the Roche cobas b 101 point-of-care system.

We have a multi-pronged approach to optimise recruitment including through lead maternity caregivers (self-employed midwives), community antenatal clinics, general practitioners, practice nurses, ultrasound clinics, community contacts, and social media. Our research team provides educational sessions for the health care providers to maximise reach for recruitment. Lead maternity caregivers notify the research team about contact details of eligible women who are interested in participating. The research midwife arranges a time to meet the woman in a suitable location to explain the study, confirm eligibility and obtain informed consent.
In order to exclude women with previously unrecognised Type 2 diabetes, HbA1c is measured in all participants (using the Roche cobas b 101 point-of-care system) prior to randomisation. If HbA1c is ≥50 mmol/mol, women are ineligible and considered to have undiagnosed diabetes [50 (link)]. They will be referred to the Diabetes in Pregnancy Service at CMH. If the HUMBA point of care HbA1c is <50 mmol/mol, then the result is not revealed to health practitioners.

Weight, mid-arm circumference, BP, and HbA1c and lipid concentrations (Roche cobas b 101 point-of-care system) are measured. Any pregnancy complications to date and use of antibiotics are recorded. The fetal movement questionnaire and functional health and well-being questionnaires including EPDS, STAI and SF-12 are repeated. Maternal urine, blood, stool, toenail clippings and hair samples are collected from consenting women for future molecular biology studies.