Pharmaceutical care of patients with gestational diabetes mellitus.
OBJECTIVE
To investigate whether the introduction of a programme of optimising drug treatment, intensive education and self-monitoring of patients diagnosed with gestational diabetes mellitus (GDM) at an early stage (<20 gestational weeks), will improve management outcomes as determined by objective measures of patient knowledge about diabetes, glycaemia control, maternal/neonatal complications, and health-related quality of life.


METHODS
The study was a randomized, controlled, longitudinal, prospective clinical trial performed at Al-Ain Hospital, Al-Ain, United Arab Emirates. Over an 18-month period, patients diagnosed with GDM were recruited and were randomly assigned to either an intervention or a control group, in a ratio of 3:2. Intervention patients received a structured pharmaceutical care service (including education and introduction of intensive self-monitoring) while control patients received traditional services. Patients were followed up from time of recruitment until 6 months postnatally at scheduled outpatient clinics. A range of clinical and humanistic outcome measures, including maternal and neonatal complications, were used to assess the impact of the intervention.


RESULTS
A total of 165 patients (99 intervention, 66 control) completed the study. The intervention patients exhibited a range of benefits from the provision of the programme when compared with control group patients. Statistically significant (P < 0.05) improvements were shown in the intervention group for knowledge of diabetes, health-related quality of life (as determined by the SF36), control of plasma glucose and HbA(1c), maternal complications [e.g. decreased incidence of pre-eclampsia (5.1% vs. 16.7%), eclampsia (1.0% vs. 7.6%), episodes of severe hyperglycaemia (3.0% vs. 19.7%) and need for Caesarean section (7.1% vs. 18.2%)], and neonatal complications [e.g. decreased incidence of neonatal hypoglycaemia (2.0% vs. 10.6%), respiratory distress at birth (4.0% vs. 15.2%), hyperbilirubinaemia (1.0% vs. 12.1%) and large for gestational age (9.0% vs. 22.7%)].


CONCLUSIONS
The research provides clear evidence that provision of pharmaceutical care adds value to the management of GDM as exemplified by improved maternal and neonatal outcomes.
Elnour
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AA
Al Ain Hospital, United Arab Emirates, and Clinical and Practice Research Group, School of Pharmacy, Queen's University Belfast, Belfast, UK.
El Mugammar
I T
IT
Jaber
T
T
Revel
T
T
McElnay
James C
JC
D000328:Adult; D019540:Area Under Curve; D015190:Blood Glucose Self-Monitoring; D015897:Comorbidity; D016640:Diabetes, Gestational / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007328:Insulin / Q000627:therapeutic use*; D008137:Longitudinal Studies; D010353:Patient Education as Topic; D011247:Pregnancy; D011256:Pregnancy Outcome; D011446:Prospective Studies; D011788:Quality of Life; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014479:United Arab Emirates
D007328:Insulin