None listed
Conditions
Brief summary
This project lays the foundations for an Australian trial to test the usefulness and safety of drug therapies to prevent the development of long-term diabetes among women who develop diabetes in pregnancy, gestational diabetes mellitus (GDM). GDM, previously considered a transient condition, is now an established risk factor for long-term diabetes. Women whose blood sugar levels do not return to normal soon after giving birth are at particularly high risk of developing established diabetes and consequent heart and blood vessel disease. Lifestyle interventions may help, but they are hard for busy mothers to adopt and sustain. Even with lifestyle interventions, these women still have substantial “residual risk”, warranting investigation of preventive drug therapies. Currently, clinical guidelines do not recommend routine use of medications because of the lack of adequate research. Our proposed research will provide critical information that will form the basis of a substantial Australian contribution to global research efforts in diabetes. Our research will: - Identify all women who were diagnosed with GDM from three (3) Sydney hospitals in the past 3 years and invite them to complete an online questionnaire and, if long-term diabetes has not already developed, to undergo a blood test to evaluate their glucose status. - Invite a sample of women to participate in interviews to understand their perspectives of GDM, long-term risks and willingness to take preventive medications (including willingness to participate in trials of preventive medicines). - Conduct interviews with healthcare providers to understand their views of long-term diabetes risk, screening and preventive strategies for women with GDM. Collectively, this study will provide a contemporary snapshot of post-GDM care and outcomes from a diverse Australian population who receive obstetric care at large urban hospitals. These data will critically inform the design and conduct of a large-scale trial of preventive medications in this and similar populations.
Interventions
Eligible and consented participants will complete an online questionnaire (30 minutes) at a time and place convenient to them. Those that have not undergone an Oral Glucose Tolerance Test (OGTT) within the previous 12 months as recommended by NSW Health will be referred for an OGTT.
Additionally, study personnel will access details relating to the participant's prior GDM-affected pregnancy, GDM treatment and any subsequent pregnancies from the hospital maternity databases (Obstetrics/eMaternit
Eligible and consented participants will complete an online questionnaire (30 minutes) at a time and place convenient to them. Those that have not undergone an Oral Glucose Tolerance Test (OGTT) within the previous 12 months as recommended by NSW Health will be referred for an OGTT. Additionally, study personnel will access details relating to the participant's prior GDM-affected pregnancy, GDM treatment and any subsequent pregnancies from the hospital maternity databases (Obstetrics/eMaternity at the Royal Hospital for Women and St George Hospital, and Cerner Maternity at Liverpool Hospital), and relevant clinics associated with the hospital. A subset of participants will be invited to participate in a semi-structured virtual (phone or online) interview to understand their perspectives of GDM, long-term risks and willingness to take preventive medications (including willingness to participate in trials of preventive medicines). Interviews with healthcare providers will also be conducted to understand their views of long-term diabetes risk, screening, and preventive strategies for women with GDM. Maximum variation sampling will be used to identify study participants for inclusion in the in-depth interviews. To identify patients, we have identified key dimensions of variation (age, severity of GDM, perception of risk of developing T2DM, highest level of education, socioeconomic status and cultural and language background). We will use these dimensions of variation to find cases that vary from each other as much as possible. This approach will give us high-quality, detailed descriptions of women's perspectives and experiences from a unique set of backgrounds. It will also enable us to document important shared patterns that cut across cases. The same sampling technique will be used to identify healthcare providers. Gender and number of years post-specialisation will be used as criteria to achieve a representative sample of this group. The healthcare providers will not necessarily have any relationship with any participants.
Sponsors
University of New South Wales
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Aged 16 years or older and gave birth following GDM-affected pregnancy at one of the study hospitals January 1st 2017-June 30th 2021. - Able to provide written informed consent. - Fluent in one of the following languages: English, Arabic, Mandarin, Vietnamese, Bangla and Hindi. Healthcare providers (obstetricians, endocrinologists, GPs) - An obstetrician or endocrinologist employed by one of the three participating hospitals (at least one participant from each of St George Hospital, Royal Hospital for Women and Liverpool Hospital); AND - A general practitioner belonging to each local GP network (identified through shared care participating hospitals) - Experience in managing patients with gestational diabetes mellitus (GDM)
Exclusion criteria
- Diagnosed with diabetes prior to pregnancy - Known inability to give informed consent to participate due to severe active mental health issues or major developmental disability.
Outcome results
None listed