Screening uptake rates and the clinical and cost effectiveness of screening for gestational diabetes mellitus in primary versus secondary care: study protocol for a randomised controlled trial.

Hdl Handle:
http://hdl.handle.net/10147/311941
Title:
Screening uptake rates and the clinical and cost effectiveness of screening for gestational diabetes mellitus in primary versus secondary care: study protocol for a randomised controlled trial.
Authors:
O Dea, Angela; Infanti, Jennifer J; Gillespie, Paddy; Tummon, Olga; Fanous, Samuel; Glynn, Liam G; McGuire, Brian E; Newell, John; Dunne, Fidelma P
Affiliation:
National University of Ireland Galway
Citation:
Screening uptake rates and the clinical and cost effectiveness of screening for gestational diabetes mellitus in primary versus secondary care: study protocol for a randomised controlled trial. 2014, 15 (1):27 Trials
Publisher:
BioMed Central
Journal:
Trials
Issue Date:
17-Jan-2014
URI:
http://hdl.handle.net/10147/311941
DOI:
10.1186/1745-6215-15-27
PubMed ID:
24438478
Additional Links:
http://www.trialsjournal.com/content/pdf/1745-6215-15-27.pdf
Abstract:
The risks associated with gestational diabetes mellitus (GDM) are well recognized, and there is increasing evidence to support treatment of the condition. However, clear guidance on the ideal approach to screening for GDM is lacking. Professional groups continue to debate whether selective screening (based on risk factors) or universal screening is the most appropriate approach. Additionally, there is ongoing debate about what levels of glucose abnormalities during pregnancy respond best to treatment and which maternal and neonatal outcomes benefit most from treatment. Furthermore, the implications of possible screening options on health care costs are not well established. In response to this uncertainty there have been repeated calls for well-designed, randomised trials to determine the efficacy of screening, diagnosis, and management plans for GDM. We describe a randomised controlled trial to investigate screening uptake rates and the clinical and cost effectiveness of screening in primary versus secondary care settings. The objective of this study is to assess screening uptake rates, and the clinical and cost effectiveness of screening for GDM in primary versus secondary care.; This is will be an unblinded, two-group, parallel randomised controlled trial (RCT). The target population includes 784 women presenting for their first antenatal visit at 12 to 18 weeks gestation at two hospitals in the west of Ireland: Galway University Hospital and Mayo General Hospital. Participants will be offered universal screening for GDM at 24 to 28 weeks gestation in either primary care (n = 392) or secondary care (n = 392) locations. The primary outcome variable is the uptake rate of screening. Secondary outcomes include indicators of clinical effectiveness of screening at each screening site (primary and secondary) including gestational week at time of screening, time to access antenatal diabetes services for women diagnosed with GDM, and pregnancy and neonatal outcomes for women with GDM. In addition, parallel economic and qualitative evaluations will be conducted. The trial will cover the period from the woman's first hospital antenatal visit at 12 to 18 weeks gestation, until the completion of the pregnancy.Trial registration: Current Controlled Trials: ISRCTN02232125.
Item Type:
Article
Language:
en
Keywords:
DIABETES MELLITUS; PREGNANCY; PRIMARY CARE; SECONDARY AND TERTIARY SERVICES
ISSN:
1745-6215

Full metadata record

DC FieldValue Language
dc.contributor.authorO Dea, Angelaen_GB
dc.contributor.authorInfanti, Jennifer Jen_GB
dc.contributor.authorGillespie, Paddyen_GB
dc.contributor.authorTummon, Olgaen_GB
dc.contributor.authorFanous, Samuelen_GB
dc.contributor.authorGlynn, Liam Gen_GB
dc.contributor.authorMcGuire, Brian Een_GB
dc.contributor.authorNewell, Johnen_GB
dc.contributor.authorDunne, Fidelma Pen_GB
dc.date.accessioned2014-01-28T10:23:34Z-
dc.date.available2014-01-28T10:23:34Z-
dc.date.issued2014-01-17-
dc.identifier.citationScreening uptake rates and the clinical and cost effectiveness of screening for gestational diabetes mellitus in primary versus secondary care: study protocol for a randomised controlled trial. 2014, 15 (1):27 Trialsen_GB
dc.identifier.issn1745-6215-
dc.identifier.pmid24438478-
dc.identifier.doi10.1186/1745-6215-15-27-
dc.identifier.urihttp://hdl.handle.net/10147/311941-
dc.description.abstractThe risks associated with gestational diabetes mellitus (GDM) are well recognized, and there is increasing evidence to support treatment of the condition. However, clear guidance on the ideal approach to screening for GDM is lacking. Professional groups continue to debate whether selective screening (based on risk factors) or universal screening is the most appropriate approach. Additionally, there is ongoing debate about what levels of glucose abnormalities during pregnancy respond best to treatment and which maternal and neonatal outcomes benefit most from treatment. Furthermore, the implications of possible screening options on health care costs are not well established. In response to this uncertainty there have been repeated calls for well-designed, randomised trials to determine the efficacy of screening, diagnosis, and management plans for GDM. We describe a randomised controlled trial to investigate screening uptake rates and the clinical and cost effectiveness of screening in primary versus secondary care settings. The objective of this study is to assess screening uptake rates, and the clinical and cost effectiveness of screening for GDM in primary versus secondary care.-
dc.description.abstractThis is will be an unblinded, two-group, parallel randomised controlled trial (RCT). The target population includes 784 women presenting for their first antenatal visit at 12 to 18 weeks gestation at two hospitals in the west of Ireland: Galway University Hospital and Mayo General Hospital. Participants will be offered universal screening for GDM at 24 to 28 weeks gestation in either primary care (n = 392) or secondary care (n = 392) locations. The primary outcome variable is the uptake rate of screening. Secondary outcomes include indicators of clinical effectiveness of screening at each screening site (primary and secondary) including gestational week at time of screening, time to access antenatal diabetes services for women diagnosed with GDM, and pregnancy and neonatal outcomes for women with GDM. In addition, parallel economic and qualitative evaluations will be conducted. The trial will cover the period from the woman's first hospital antenatal visit at 12 to 18 weeks gestation, until the completion of the pregnancy.Trial registration: Current Controlled Trials: ISRCTN02232125.-
dc.languageENG-
dc.language.isoenen
dc.publisherBioMed Centralen_GB
dc.relation.urlhttp://www.trialsjournal.com/content/pdf/1745-6215-15-27.pdfen_GB
dc.rightsArchived with thanks to Trialsen_GB
dc.subjectDIABETES MELLITUSen_GB
dc.subjectPREGNANCYen_GB
dc.subjectPRIMARY CAREen_GB
dc.subjectSECONDARY AND TERTIARY SERVICESen_GB
dc.titleScreening uptake rates and the clinical and cost effectiveness of screening for gestational diabetes mellitus in primary versus secondary care: study protocol for a randomised controlled trial.en_GB
dc.typeArticleen
dc.contributor.departmentNational University of Ireland Galwayen_GB
dc.identifier.journalTrialsen_GB
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