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Problem Statement/Hypothesis:  Pregnant women enrolled in clinical research studies requiring samples to be collected at delivery afford the researcher only one opportunity to collect those samples, which if not collected, result in incomplete data sets.  We hypothesize that the inclusion of a “time out” review for all cesarean and vaginal births will increase research sample collection. We sought to evaluate the effectiveness of implementing a time-out intervention when pregnant study participants deliver in order to enhance the collection of biological research samples.
Literature Review:  Perinatal research literature is mostly void in describing specific methods of who identifies pregnant study subjects in labor and delivery and how research samples are collected from the pregnant woman at the time of delivery.  Recent obstetrical studies describe specific biological samples being collected at delivery; however most studies fail to describe how the medical and nursing staff knows to collect the data.  In 2006, as part of the national patient safety goals, the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) recommended a perioperative verification process, or “time out,” to include identification of correct patient, correct site, correct side, correct procedure, correct position for the procedure, and the availability of special equipment if needed (JCAHO, 2007).   
Methodology:  Study subjects included pregnant women delivering at DUMC who previously consented to IRB approved studies requiring research samples at delivery.  Obstetrical staff were educated on the implementation of a vaginal delivery time out which included research participation.  Collection rates of research samples obtained at delivery were collected retrospectively from women delivering by cesarean and prospectively after implementation of research in the time out procedure for those subjects delivering vaginally.
Data Analysis & Interpretation:  Prior to study implementation, 105 subjects delivered vaginally and were on one or more studies.  Of those, 65.7% (69/105) had research samples collected for all studies.  After study implementation, 83 of 97 (85.6%) subjects who delivered vaginally had samples collected for all studies (p=0.001).  Eighty-four of the 97 subjects (86.6%) had documentation of the time out procedure, of whom 89.3% (75/84) had all samples collected.  Of the 13 without time out documentation, only 8 had all samples collected (61.5%, p=0.008).  Implementation and documentation of time out in vaginal deliveries improved research sample collection.
Implications for Nursing Practice:  By implementing a successful intervention to collect blood and tissue samples at delivery, the researcher is able to obtain those data which are crucial to answering important perinatal research hypotheses.  Including research in all obstetrical time out procedures provides additional assurance that compliance with the JCAHO patient safety goals is being met.  The inclusion of research participation in obstetrical time out procedures is an effective intervention maximizing research sample collection at delivery, which may be implemented by others.