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.
RCT Entities:
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.
Authors: Carmel M Hughes; Ahmed F Hawwa; Claire Scullin; Claire Anderson; Cecilia B Bernsten; Ingunn Björnsdóttir; Maria A Cordina; Filipa Alves da Costa; Isabelle De Wulf; Patrick Eichenberger; Veerle Foulon; Martin C Henman; Kurt E Hersberger; Marion A Schaefer; Birthe Søndergaard; Mary P Tully; Tommy Westerlund; James C McElnay Journal: Pharm World Sci Date: 2010-05-11
Authors: Julie Brown; Nisreen A Alwan; Jane West; Stephen Brown; Christopher Jd McKinlay; Diane Farrar; Caroline A Crowther Journal: Cochrane Database Syst Rev Date: 2017-05-04
Authors: Karl Horvath; Klaus Koch; Klaus Jeitler; Eva Matyas; Ralf Bender; Hilda Bastian; Stefan Lange; Andrea Siebenhofer Journal: BMJ Date: 2010-04-01
Authors: Diane Farrar; Mark Simmonds; Maria Bryant; Trevor A Sheldon; Derek Tuffnell; Su Golder; Debbie A Lawlor Journal: BMJ Open Date: 2017-06-24 Impact factor: 2.692