Abstract | RATIONALE, AIMS AND 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%)]. CONCLUSION: 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.
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Authors | A A Elnour, I T El Mugammar, T Jaber, T Revel, James C McElnay |
Journal | Journal of evaluation in clinical practice
(J Eval Clin Pract)
Vol. 14
Issue 1
Pg. 131-40
(Feb 2008)
ISSN: 1365-2753 [Electronic] England |
PMID | 18211656
(Publication Type: Journal Article, Randomized Controlled Trial)
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Chemical References |
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Topics |
- Adult
- Area Under Curve
- Blood Glucose Self-Monitoring
- Comorbidity
- Diabetes, Gestational
(drug therapy)
- Female
- Humans
- Insulin
(therapeutic use)
- Longitudinal Studies
- Patient Education as Topic
- Pregnancy
- Pregnancy Outcome
- Prospective Studies
- Quality of Life
- Statistics, Nonparametric
- Surveys and Questionnaires
- Treatment Outcome
- United Arab Emirates
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