Gestational Diabetes Mellitus in Pregnancy
Conditions
Keywords
diet modification, 4 and 7 points monitoring
Brief summary
This study aims to compare between 4 and 7 points blood glucose monitoring in women with gestational diabetes on diet modification.
Detailed description
All women with gestational diabetes on diet modification will be recruited and randomised to 4 versus 7 points self monitoring blood glucose. They will be followed up 4 weekly and the pregnancy outcomes will be evaluated.
Interventions
DIETARY_SUPPLEMENTdiabetic diet
Patients with gestational diabetes will be seen by the dietitian to be taught diet modification
Sponsors
National University of Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
All women with gestational diabetes are randomised to 4 or 7 points of self monitoring blood glucose.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18-45 years old * Pregnant women with gestational diabetes mellitus on diet modification * Confirmed gestational diabetes mellitus using National Institute for Health and Care Excellence guideline by 75g oral glucose tolerance test after 14 weeks * Gestational age at recruitment 20-34 week
Exclusion criteria
* bad obstetrics history. * Women with underlying medical disorders such as hypertension, autoimmune diseases on steroids * fetal anomaly. * Women planning to deliver in other centres * Women who refuse to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy outcome of participants | From date of randomisation up to 40 weeks gestation | Mean gestational age at delivery in weeks |
| Demographic data of participants | On the date of randomisation | Mean age of participants in years |
| Clinical characteristics of participants | On the date of randomisation up to 40 weeks gestation | Mean gestational age gestational diabetes mellitus is diagnosed in weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Requirement of treatment in participants | From the date of randomisation up to 40 weeks gestation | Mean gestational age that the participants are detected to require added treatment in weeks |
| Participants' compliance | From point of randomisation till 40 weeks gestation | Rate of frequency of four weekly self blood glucose monitoring in percentage |
| Participants' satisfaction | From point of randomisation till 40 weeks gestation | Rate of participants' satisfaction whether satisfied, neutral or not satisfied in percentage |
Countries
Malaysia
Outcome results
None listed