Browsing by Author "Pierson, Rebecca C."
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Item Buccal versus Vaginal Misoprostol for Term Induction of Labor: A Retrospective Cohort Study(Thieme, 2019-06) Dorr, Meredith L.; Pierson, Rebecca C.; Daggy, Joanne; Quinney, Sara K.; Haas, David M.; Obstetrics and Gynecology, School of MedicineOBJECTIVE: To compare the efficacy of similar buccal and vaginal misoprostol doses for induction of labor. STUDY DESIGN: Retrospective chart review of 207 consecutive women undergoing term induction of labor with misoprostol. Misoprostol route and dosing were collected. Time to delivery and other labor outcomes (e.g., vaginal delivery less than 24 hours) were compared between women receiving buccal and vaginal misoprostol. RESULTS: There was no significant difference in time to delivery for women receiving buccal (median 18.2 hour, 95% confidence interval [CI] = [14.9, 21.5]) versus vaginal (median 18.3 hour, 95% CI = [15.0, 20.4]) misoprostol (p = 0.428); even after adjusting for covariates (p = 0.381). Women who presented with premature rupture of membranes were more likely to receive buccal misoprostol (92.7% received buccal vs. 7.3% received vaginal, p < 0.001). A similar number of women delivered vaginally in the buccal group (88.2%) and vaginal misoprostol group (86.8%, p = 0.835). The proportion of women who experienced uterine tachysystole or chorioamnionitis did not significantly differ by route of administration. CONCLUSION: We found no significant differences in time to delivery or other labor outcomes between buccal or vaginal dosing of misoprostol in women undergoing labor induction at term.Item Clinical and educational impact of pharmacogenomics testing: a case series from the INGENIOUS trial(Future Medicine, 2017-06) Pierson, Rebecca C.; Gufford, Brandon T.; Desta, Zeruesenay; Eadon, Michael T.; Medicine, School of MedicinePharmacogenomic testing has become increasingly widespread. However, there remains a need to bridge the gap between test results and providers lacking the expertise required to interpret these results. The Indiana Genomics Implementation trial is underway at our institution to examine total healthcare cost and patient outcomes after genotyping in a safety-net healthcare system. As part of the study, trial investigators and clinical pharmacology fellows interpret genotype results, review patient histories and medication lists and evaluate potential drug-drug interactions. We present a case series of patients in whom pharmacogenomic consultations aided providers in appropriately applying pharmacogenomic results within the clinical context. Formal consultations not only provide valuable patient care information but educational opportunities for the fellows to cement pharmacogenomic concepts.Item A comparison of vaginal versus buccal misoprostol for cervical ripening in women for labor induction at term (the IMPROVE trial): a triple-masked randomized controlled trial(Elsevier, 2019) Haas, David M.; Daggy, Joanne; Flannery, Kahtleen M.; Dorr, Meredith L.; Bonsack, Carrie; Bhamidipalli, Surya S.; Pierson, Rebecca C.; Lathrop, Anthony; Towns, Rachel; Ngo, Nicole; Head, Annette; Morgan, Sarah; Quinney, Sara K.; Obstetrics and Gynecology, School of MedicineBackground Cervical ripening is commonly needed for labor induction. Finding an optimal route of misoprostol dosing for efficacy, safety, and patient satisfaction is important and not well studied for the buccal route. Objective To compare the efficacy and safety of vaginal and buccal misoprostol for women undergoing labor induction at term. Study Design The IMPROVE trial was an institutional review board–approved, triple-masked, placebo-controlled randomized noninferiority trial for women undergoing labor induction at term with a Bishop score ≤6. Enrolled women received 25 mcg (first dose), then 50 mcg (subsequent doses) of misoprostol by assigned route (vaginal or buccal) and a matching placebo tablet by the opposite route. The primary outcomes were time to delivery and the rate of cesarean delivery performed urgently for fetal nonreassurance. A sample size of 300 was planned to test the noninferiority hypothesis. Results The trial enrolled 319 women, with 300 available for analysis, 152 in the vaginal misoprostol group and 148 in the buccal. Groups had similar baseline characteristics. We were unable to demonstrate noninferiority. The time to vaginal delivery was lower for the vaginal misoprostol group (median [95% confidence interval] in hours: vaginal: 20.1 [18.2, 22.8] vs buccal: 28.1 [24.1, 31.4], log-rank test P = .006, Pnoninferiority = .663). The rate of cesarean deliveries for nonreassuring fetal status was 3.3% for the vaginal misoprostol group and 9.5% for the buccal misoprostol group (P = .033). The rate of vaginal delivery in <24 hours was higher in the vaginal group (58.6% vs 39.2%, P = .001). Conclusion We were unable to demonstrate noninferiority. In leading to a higher rate of vaginal deliveries, more rapid vaginal delivery, and fewer cesareans for fetal issues, vaginal misoprostol may be superior to buccal misoprostol for cervical ripening at term.Item Increasing Influenza Vaccination Rates in a Busy Urban Clinic(JNSCI.org, 2015) Pierson, Rebecca C.; Malone, Anita M.; Haas, David M.; Department of Obstetrics & Gynecology, IU School of MedicineInfluenza infection is the cause of thousands of hospitalizations and deaths each year; infection during pregnancy results in increased morbidity and mortality. Underserved women are particularly susceptible to not receiving recommended vaccinations. This project explored the effect of a simple paper based prompt on the influenza vaccination rate in a resident continuity clinic for the underserved. Using this reminder to providers to discuss the influenza vaccination with their patients, we were able to increase vaccination rates in our clinic from 2.2% to 14.2%. This implementation of a simple, low cost, low tech prompt to providers increased the rate of influenza vaccination in our clinic and we present this approach as an easy to implement method of improving vaccination rates. We also suggest this method as an alternative to an alert in the electronic medical record in situations where the electronic medical record may not be accessed during every patient encounter.Item Pharmacokinetics of vaginal versus buccal misoprostol for labor induction at term(Wiley, 2022) Vorontsova, Yana; Haas, David M.; Flannery, Kathleen; Masters, Andrea R.; Silva, Larissa L.; Pierson, Rebecca C.; Yeley, Brittany; Hogg, Graham; Guise, David; Heathman, Michael; Quinney, Sara K.; Obstetrics and Gynecology, School of MedicineThe IMPROVE study (NCT02408315) compared the efficacy and safety of vaginal and buccal administration of misoprostol for full-term, uncomplicated labor induction. This report compares the pharmacokinetics of misoprostol between vaginal and buccal routes. Women greater than or equal to 14 years of age undergoing induction of labor greater than or equal to 37 weeks gestation without significant complications were randomized to vaginal or buccal misoprostol 25 μg followed by 50 μg doses every 4 h. Misoprostol acid concentrations were determined using liquid chromatography-tandem mass spectrometry for the first 8 h in a subgroup of participants. A population pharmacokinetic model was developed using NONMEM. Plasma concentrations (n = 469) from 47 women were fit to a one-compartment nonlinear clearance model. The absorption rate constant (ka ) was dependent on both route and dose of administration: buccal 25 μg 0.724 (95% confidence interval, 0.54-0.92) h-1 ; 50 μg 0.531 (0.37-0.63) h-1 ; vaginal 25 μg 0.507 (0. 2-1. 4) h-1 ; and 50 μg 0.246 (0.103-0.453) h-1 . Relative bioavailability for vaginal compared to buccal route was 2.4 (1.63-4.77). There was no effect of body mass index or age on apparent clearance 705 (431-1099) L/h or apparent volume of distribution 632 (343-1008) L. The area under the concentration-time curve to 4 h following the first 25 μg dose of misoprostol was 16.5 (15.4-17.5) pg h/ml for buccal and 34.3 (32.5-36.1) pg h/ml for vaginal administration. The rate of buccal absorption was two times faster than that of vaginal, whereas bioavailability of vaginal administration was 2.4 times higher than that of buccal. Decreased time to delivery observed with vaginal dosing may be due to higher exposure to misoprostol acid compared to buccal.Item A retrospective comparison of antibiotic regimens for preterm premature rupture of membranes(Ovid Technologies (Wolters Kluwer) - Lippincott Williams & Wilkins, 2014-09) Pierson, Rebecca C.; Gordon, Sashana S.; Haas, David M.; Department of Obstetrics & Gynecology, IU School of MedicineOBJECTIVE: To evaluate whether the use of ampicillin and azithromycin leads to a similar latency period in preterm premature rupture of membranes as ampicillin and erythromycin and whether the substitution of azithromycin for erythromycin effects rates of other outcomes. METHODS: We performed a retrospective cohort study of women with preterm premature rupture of membranes between 24 and 34 completed weeks of gestation and compared two groups: those who received ampicillin and erythromycin and those who received ampicillin and azithromycin. Primary outcome was length of latency (defined as time from first antibiotic dose to delivery) and secondary outcomes were rates of chorioamnionitis, cesarean delivery, Apgar scores, birth weight, neonatal death, neonatal sepsis, and neonatal respiratory distress syndrome. RESULTS: Of 168 women who met inclusion criteria, 75 received ampicillin and erythromycin and 93 received ampicillin and azithromycin. There was no difference in latency between groups: 9.6±13.2 days (erythromycin) compared with 9.4±10.0 (azithromycin) days (P=.40). Secondary outcomes did not differ between groups. We had 80% power to detect a difference of 5 days. CONCLUSION: Among women with preterm premature rupture of membranes between 24 and 34 completed weeks of gestation, substitution of azithromycin for erythromycin in the recommended antibiotic regimen did not affect latency or any other measured maternal or fetal outcomes. LEVEL OF EVIDENCE: III.Item A review of post-caesarean infectious morbidity: how to prevent and treat(Taylor & Francis, 2018) Pierson, Rebecca C.; Scott, Nicole P.; Briscoe, Kristin E.; Haas, David M.; Obstetrics and Gynecology, School of MedicinePost-caesarean infectious complications result in significant maternal morbidity and mortality as well as increased readmissions and increased health care cost worldwide. This review provides a discussion of several risk factors that have been identified which predispose women to post-surgical infection. We also provide an overview of strategies for infection prevention including antibiotics, surgical techniques and negative pressure wound therapy. Criteria for diagnosis of wound infection are provided, as well as appropriate treatment regimens. Given the impact of maternal post caesarean infection, it is important for women’s health care providers to understand how to prevent these infections, as well as recognise and treat them.Item Survey of Provider Preferences Regarding the Route of Misoprostol for Induction of Labor at Term(Thieme, 2017-07) Towns, Rachel; Quinney, Sara K.; Pierson, Rebecca C.; Haas, David M.; Obstetrics and Gynecology, School of MedicineIn the absence of shorter term disinfectant byproducts (DBPs) data on regulated Trihalomethanes (THMs) and Haloacetic acids (HAAs), epidemiologists and risk assessors have used long-term annual compliance (LRAA) or quarterly (QA) data to evaluate the association between DBP exposure and adverse birth outcomes, which resulted in inconclusive findings. Therefore, we evaluated the reliability of using long-term LRAA and QA data as an indirect measure for short-term exposure. Short-term residential tap water samples were collected in peak DBP months (May-August) in a community water system with five separate treatment stations and were sourced from surface or groundwater. Samples were analyzed for THMs and HAAs per the EPA (U.S. Environmental Protection Agency) standard methods (524.2 and 552.2). The measured levels of total THMs and HAAs were compared temporally and spatially with LRAA and QA data, which showed significant differences (p < 0.05). Most samples from surface water stations showed higher levels than LRAA or QA. Significant numbers of samples in surface water stations exceeded regulatory permissible limits: 27% had excessive THMs and 35% had excessive HAAs. Trichloromethane, trichloroacetic acid, and dichloroacetic acid were the major drivers of variability. This study suggests that LRAA and QA data are not good proxies of short-term exposure. Further investigation is needed to determine if other drinking water systems show consistent findings for improved regulation.Item The INGENIOUS Trial: Impact of pharmacogenetic testing on adverse events in a pragmatic clinical trial(Springer Nature, 2023) Eadon, Michael T.; Rosenman, Marc B.; Zhang, Pengyue; Fulton, Cathy R.; Callaghan, John T.; Holmes, Ann M.; Levy, Kenneth D.; Gupta, Samir K.; Haas, David M.; Vuppalanchi, Raj; Benson, Eric A.; Kreutz, Rolf P.; Tillman, Emma M.; Shugg, Tyler; Pierson, Rebecca C.; Gufford, Brandon T.; Pratt, Victoria M.; Zang, Yong; Desta, Zeruesenay; Dexter, Paul R.; Skaar, Todd C.; Medicine, School of MedicineAdverse drug events (ADEs) account for a significant mortality, morbidity, and cost burden. Pharmacogenetic testing has the potential to reduce ADEs and inefficacy. The objective of this INGENIOUS trial (NCT02297126) analysis was to determine whether conducting and reporting pharmacogenetic panel testing impacts ADE frequency. The trial was a pragmatic, randomized controlled clinical trial, adapted as a propensity matched analysis in individuals (N = 2612) receiving a new prescription for one or more of 26 pharmacogenetic-actionable drugs across a community safety-net and academic health system. The intervention was a pharmacogenetic testing panel for 26 drugs with dosage and selection recommendations returned to the health record. The primary outcome was occurrence of ADEs within 1 year, according to modified Common Terminology Criteria for Adverse Events (CTCAE). In the propensity-matched analysis, 16.1% of individuals experienced any ADE within 1-year. Serious ADEs (CTCAE level ≥ 3) occurred in 3.2% of individuals. When combining all 26 drugs, no significant difference was observed between the pharmacogenetic testing and control arms for any ADE (Odds ratio 0.96, 95% CI: 0.78-1.18), serious ADEs (OR: 0.91, 95% CI: 0.58-1.40), or mortality (OR: 0.60, 95% CI: 0.28-1.21). However, sub-group analyses revealed a reduction in serious ADEs and death in individuals who underwent pharmacogenotyping for aripiprazole and serotonin or serotonin-norepinephrine reuptake inhibitors (OR 0.34, 95% CI: 0.12-0.85). In conclusion, no change in overall ADEs was observed after pharmacogenetic testing. However, limitations incurred during INGENIOUS likely affected the results. Future studies may consider preemptive, rather than reactive, pharmacogenetic panel testing.