ABSTRACT
OBJECTIVE: There is a dearth of biospecimen repositories available to perinatal researchers. In order to address this need, here we describe the methodology used to establish such a resource. STUDY DESIGN: With the collaboration of MedSci.net, we generated an online perinatal database with 847 fields of clinical information. Simultaneously, we established a biospecimen repository of the same clinical participants. RESULTS: The demographic and clinical outcomes data are described for the first 10 000 participants enrolled. The demographic characteristics are consistent with the demographics of the delivery hospitals. Quality analysis of the biospecimens reveals variation in very few analytes. Furthermore, since the creation of PeriBank, we have demonstrated validity of the database and tissue integrity of the biospecimen repository. CONCLUSION: Here we establish that the creation of a universal perinatal database and biospecimen collection is not only possible, but allows for the performance of state-of-the-science translational perinatal research and is a potentially valuable resource to academic perinatal researchers.
Subject(s)
Biological Specimen Banks/organization & administration , Databases, Factual/standards , Perinatology , Specimen Handling/methods , Database Management Systems , HumansABSTRACT
OBJECTIVE: This prospective observational study explored the association of hypertensive disorders of pregnancy and small-for-gestational age with obstructive sleep apnea (OSA) as determined by screening measures for OSA and sleep studies. STUDY DESIGN: Two symptom-based screening questionnaires, the Berlin Questionnaire (BQ) and the Epworth Sleepiness Scale (ESS), were administered to enroll 1509 gravidae. Screen-positive subjects were referred for polysomnography. The primary outcome was the occurrence of either gestational hypertension or preeclampsia. Generalized linear models (GLM) were used to estimate the relative risks of associations. RESULT: One thousand one hundred and fifty-seven subjects were available for outcomes analysis. Screening positive on the BQ was positively associated with hypertensive disorders in GLM models (adjusted relative risk=1.90, 95% confidence interval 1.52 to 2.37). CONCLUSION: In this large prospective trial, GLM modeling suggests that the BQ but not the ESS demonstrated significant association with measured adverse pregnancy outcomes, and specific items predicted these outcomes better than others. However, causative association of BQ with OSA cannot be assumed.
Subject(s)
Hypertension, Pregnancy-Induced/diagnosis , Infant, Small for Gestational Age , Pre-Eclampsia/diagnosis , Pregnancy Outcome , Sleep Apnea, Obstructive/diagnosis , Adult , Female , Humans , Mass Screening , Middle Aged , Polysomnography , Pregnancy , Prospective Studies , Risk Assessment , Risk Factors , Surveys and Questionnaires , Young AdultABSTRACT
OBJECTIVE: We sought to ascertain the validity of two screening scales for obstructive sleep apnea (OSA) in pregnancy and to establish the prevalence of OSA in pregnancy. STUDY DESIGN: In this prospective observational study, two screening scales were administered. Screen positive subjects were referred for diagnostic polysomnography (PSG); if admitted for antepartum care, screen positive subjects underwent a modified study with a type 3 device (T3D). RESULT: A total of 1509 subjects underwent OSA screening; 58 completed diagnostic testing. Neither measure was a reliable diagnostic tool for OSA as determined by T3D or PSG (detection rates of 10.3% and 18.0%, respectively). Among screen positive subjects undergoing PSG or T3D testing, 15.5% ultimately met 'gold standard' OSA diagnostic criteria for an estimated point prevalence of 4.9%. CONCLUSION: In this prospective trial, screening positive on the Berlin questionnaire or Epworth sleepiness scale was poorly predictive of OSA among gravidae and was associated with a high false referral rate.
