Gestational Diabetes Mellitus Pregnancy and Childbirth Diabetes mellitus arising in pregnancy
Conditions
Interventions
The experimental arm will receive the DVD in addition to standard/usual care.
The control arm will receive standard/usual care alone.
Sponsors
Queen's University Belfast (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Age 16 or older 2. Pregnant women with a recent new diagnosis of GDM (as per IADPSG criteria) ? eligible if ?YES? to one of the following criteria: 2.1. Fasting plasma glucose, HbA1C, or random plasma glucose at booking: 2.2. Fasting plasma glucose = 5.1 mmol/l (92 mg/dl) but <7.0 mmol/l (126 mg/dl) 3. OGTT after 24 weeks gestation: 3.1. FPG = 5.1 mmol/l (92 mg/dl) 3.2. 1-h plasma glucose = 10.0 mmol/l (180 mg/dl) 3.3. 2-h plasma glucose = 8.5 mmol/l (153 mg/dl)
Exclusion criteria
Exclusion criteria: 1. Diagnosed with GDM in a previous pregnancy 2. Deemed inappropriate for woman to take part in the RCT by their Consultant Obstetrician / Physician, for example if a poor pregnancy outcome is anticipated. 3. Diagnosed with type 1 or type 2 diabetes during this pregnancy 4.Taking part in another research study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Maternal anxiety at study visit 2 (2 weeks after randomization) 2. Mean 1 hour post-prandial glucose as part of a 7 point glucose profile in the 24 hour period prior to visit 2 (2 weeks after randomization) as measured by self blood glucose monitoring | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pregnancy specific stress at visit 2 2. Emotional adjustment to diabetes at visit 2 3. Self-efficacy at visit 2 4. Knowledge of gestational diabetes at visit 2 Maternal anxiety at visit 3 (6 weeks post delivery) 5. Risk Perception Survey for Developing Diabetes (RPS-DD) Visit 3 | — |
Countries
United Kingdom
Outcome results
None listed