An Intervention to Maximize Research Sample Collection for Pregnant Subjects at Delivery

Abstract

regnant women enrolled in clinical researchstudies requiring samples to be collected atdelivery aiord the researcheronly one opportunityto collect those samples, which if not collected re-sult in incomplete data sets. We hypothesized thatthe inclusion of a‘‘time out’’ review forall Cesareanand vaginal births would increase research samplecollection.We sought to evaluate the eiectivenessof implementinga time-out intervention whenpreg-nant study participants deliver in order to enhancethe collectionof biological research samples.Literature ReviewPerinatal research literature is mostly void in de-scribing speci¢c methods for identifying pregnantstudy subjects in labor and delivery and how re-search samples are collected at the time ofdelivery. Recent obstetric studies describe speci¢cbiological samples being collected at delivery;however most studies do not describe how themedicalandnursingstaiknowstocollect thedata.In 2006, aspartofthe national patient safety goals,the Joint Commission on the Accreditation ofHealthcare Organizations (JCAHO) recommendeda perioperative veri¢cation process, or ‘‘time out,’’to include identi¢cation of correct patient, correctsite, correct side, correct procedure, correct posi-tion for the procedure, and the availability ofspecial equipment ifneeded (2007).MethodologyStudy subjects included pregnant women deliver-ing at Duke University Medical Center (DUMC) whopreviously consented to IRB approved studies re-quiring research samples at delivery.Obstetric staiwere educated on the implementation of a vaginaldelivery time out that included research participa-tion.Collection rates of research samples obtainedat delivery were collected retrospectively from wo-men delivering by Cesarean and prospectivelyafterimplementationofresearchinthetimeoutpro-cedurefor those subjects delivering vaginally.Data Analysis & InterpretationPrior to study implementation, 105 subjects deliv-ered vaginally and were on one or more studies.Ofthose, 65.7% (69/105) had research samples col-lected forall studies. After study implementation, 83of 97 (85.6%) subjects who delivered vaginallyhadsamples collected for all studies (p5.001). Eighty-fourofthe 97 subjects (86.6%) had documentationof the time out procedure; of these 89.3% (75/84)had all samples collected. Of the 13 without timeout documentation, only 8 had all samples col-lected (61.5%, p5.008). Implementation anddocumentation of time out in vaginal deliveriesimproved research sample collection.Implications for Nursing PracticeByimplementingasuccessfulinterventiontocollectblood and tissue samples at delivery, the re-searcher is able to obtain those data that arecrucial to answering important perinatal researchhypotheses. Including research in all obstetric timeout procedures provides additional assurance thatcompliance with the JCAHO patient safety goals isbeing met. The inclusion of research participationinobstetrictimeoutproceduresisaneiectiveinter-vention maximizing research sample collection atdelivery that maybe implementedbyothers.