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Item 4408 Using a human-centered design process to address challenges of engaging pregnant & parenting women with opioid use disorder(Cambridge University Press, 2020-07-29) Wiehe, Sarah; Lynch, Dustin; Moore, Courtney; Cockrum, Brandon; Hawryluk, Bridget; Claxton, Gina; Pediatrics, School of MedicineOBJECTIVES/GOALS: Using a human-centered approach, IDEO, a nationally-renown human-centered design team, and Research Jam, Indiana CTSI’s patient engagement core, integrated and tailored complimentary programs to address the challenges of engaging mothers with opioid misuse around the time of birth. METHODS/STUDY POPULATION: Gathered data through focus groups, site visits, and one-on-one interviews with key stakeholders: mothers in opioid use recovery, peer recovery coaches, and other people living with or directly affected by opioid use disorder (OUD). RESULTS/ANTICIPATED RESULTS: Themes emerged around stigma (e.g., constant judgment, majority of interactions focused on addiction, addiction comes from bad choices), the healthcare system (e.g., healthcare system bias and stigma, misalignment of services and timing of need, no support for support network), and relating to recovery (very variable but generally ambiguous and uncertain process and outcomes, importance of peer recovery coaches, importance of community resources). Identified themes were used to create insights that informed the underlying concepts of an engagement strategy including support and resources for recovery coaches, and education materials for mothers with OUD. One of human-centered design’s strengths is iteration, and the materials created for this have yet to be tested and refined thoroughly to be meaningful and lasting interventions. DISCUSSION/SIGNIFICANCE OF IMPACT: Considerable insights into the lived experience of those experiencing OUD and those who support these individuals yielded tangible ways to test improved engagement and recruitment of women with OUD at the time of birth.Item 786 Neonatal outcomes in pregnant women with diagnosis of COVID-19(Elsevier, 2021) Izewski, Joanna; Boudova, Sarah; Rouse, Caroline E.; Ibrahim, Sherrine A.; Shanks, Anthony L.; Reinhardt, Jeff C.; Scifres, Christina; Haas, David M.; Peipert, Jeffrey F.; Tuuli, Methodius G.; Obstetrics and Gynecology, School of MedicineObjective It is unclear whether infection with COVID-19 during pregnancy increases the risk of adverse neonatal outcomes. We tested the hypothesis that a diagnosis of COVID-19 during pregnancy increases the risk of neonatal respiratory morbidity and other adverse neonatal outcomes. Study Design: Retrospective analysis of prospectively collected data from two labor and delivery units with universal COVID-19 testing policy between March 1 and May 31, 2020. Pregnant women with singleton pregnancies who delivered during the study period and underwent testing for COVID-19 at any point in their pregnancy were eligible. The primary outcome was a composite of neonatal respiratory morbidity defined as the occurrence of any one of the following: respiratory distress syndrome, transient tachypnea of the newborn, and need for respiratory support. The risk of neonatal morbidity with and without a COVID-19 diagnosis were compared using univariable and multivariable analyses. Stratified analysis compared the risks of adverse neonatal outcomes in symptomatic and asymptomatic patients with COVID-19 to those without COVID-19. Results: Of 515 subjects meeting inclusion criteria, 55 (10.7%) tested positive for COVID-19; 19 (34.6%) were asymptomatic and 36 (65.4%) were symptomatic. No neonate tested positive for COVID-19. Rates of the primary outcome, composite neonatal respiratory morbidity, were not significantly different in patients with and without COVID-19 (21.8% vs 19.6%, P=0.692). There was no significant difference in the risk of neonatal respiratory morbidity in a Cox regression model accounting for time from diagnosis to delivery, and adjusting for gestational age at delivery, mode of delivery, and maternal diabetes (adjusted hazard ratio: 0.62; 95% CI 0.35, 1.09). There were no significant differences in any of the secondary outcomes in patients with COVID-19 who were asymptomatic or symptomatic (Table). Conclusion: A diagnosis of COVID-19 during pregnancy does not appear to increase the risk of neonatal morbidity. These data may be useful in counseling women diagnosed with COVID-19 during pregnancy.Item A cross-sectional survey of genetic counselors providing carrier screening regarding GBA variants and Parkinson disease susceptibility(Springer, 2022) Jones, Tara A.; Schulze, Jeanine; Aufox, Sharon; Rothstein, Jason; Arjunan, Aishwarya; Medical and Molecular Genetics, School of MedicinePurpose: Adult-onset disease risks associated with carriers of recessive disease have and will continue to be identified. As carrier screening becomes more broadly utilized, providers face the dilemma of whether they should discuss these risks during discussions with prospective parents. This study aimed to understand whether preconception/prenatal genetic counselors (PPGCs) were aware of the risk of Parkinson disease in carriers of, and persons with, Gaucher disease and the reasons behind choosing whether to discuss this risk with patients. Methods: Eligible participants included board-certified or board-eligible genetic counselors who had counseled preconception/prenatal patients within the past 3 years. An online survey was distributed via the National Society of Genetic Counselors in November of 2017. Results: One hundred twenty genetic counselors completed the quantitative survey, distributed in Fall of 2017. While the majority of respondents knew of the Gaucher-related Parkinson's link (n = 78; 65%), just over one-third reported discussing it in preconception/prenatal settings (n = 30; 38.5%). Respondents reported discussing these links more consistently when disclosing positive results or when the patient/family approached the topic. Respondents cited the lack of professional guidelines as one of the main reasons for not discussing the link. Conclusion: These results highlight an inconsistency in PPGCs' discussions of the Parkinson's risk in Gaucher disease carriers, and the need to develop guidelines regarding these issues to help standardize the care and education of patients.Item A human-centered designed outreach strategy for a youth contraception navigator program(Elsevier, 2022) Wilkinson, Tracey A.; Hawryluk, Bridget; Moore, Courtney; Peipert, Jeffrey F.; Carroll, Aaron E.; Wiehe, Sarah; Fortenberry, J. Dennis; Pediatrics, School of MedicineObjective: To identify key elements of an outreach strategy for a youth contraception navigator program designed to help young people overcome barriers to contraception access. Methods: A human-centered design approach was used to engage adolescents aged 15-17 in co-design sessions. Human-centered design techniques, such as affinity diagramming and model building were used to inform key elements of the communication model and the final outreach strategy messages. Results: Messages focused on the individual, normalizing talking about birth control, acknowledging the challenges to obtaining birth control, explaining how the navigator program works resonate with young people. Having images of diverse participants, offering information about birth control, and showing images of reputable sources will enhance trust. Conclusions: A name (IN Control) and key elements of an outreach strategy were determined for the navigator program. It is important to work with key stakeholders and co-design the optimal strategy and messages to assure that the intended audience is reached, and the desired behavior change is achieved. Innovation: Human-centered design techniques can be used to provide insight into programmatic outreach strategies for a contraception navigator program to increase their impact and ultimate success.Item A qualitative study of the barriers and enhancers to retention in care for pregnant and postpartum women living with HIV(Public Library of Science, 2021-10-13) Humphrey, John; Alera, Marsha; Kipchumba, Bett; Pfeiffer, Elizabeth J.; Songok, Julia; Mwangi, Winfred; Musick, Beverly; Yiannoutsos, Constantin; Wachira, Juddy; Wools-Kaloustian, Kara; Medicine, School of MedicineRetention in care is a major challenge for pregnant and postpartum women living with HIV (PPHIV) in the prevention of mother-to-child HIV transmission (PMTCT) continuum. However, the factors influencing retention from the perspectives of women who have become lost to follow-up (LTFU) are not well described. We explored these factors within an enhanced sub-cohort of the East Africa International Epidemiology Databases to Evaluate AIDS Consortium. From 2018-2019, a purposeful sample of PPHIV ≥18 years of age were recruited from five maternal and child health clinics providing integrated PMTCT services in Kenya. Women retained in care were recruited at the facility; women who had become LTFU (last visit >90 days) were recruited through community tracking. Interview transcripts were analyzed thematically using a social-ecological framework. Forty-one PPHIV were interviewed. The median age was 27 years, 71% were pregnant, and 39% had become LTFU. In the individual domain, prior PMTCT experience and desires to safeguard infants' health enhanced retention but were offset by perceived lack of value in PMTCT services following infants' immunizations. In the peer/family domain, male-partner financial and motivational support enhanced retention. In the community/society domain, some women perceived social pressure to attend clinic while others perceived pressure to utilize traditional birth attendants. In the healthcare environment, long queues and negative provider attitudes were prominent barriers. HIV-related stigma and fear of disclosure crossed multiple domains, particularly for LTFU women, and were driven by perceptions of HIV as a fatal disease and fear of partner abandonment and abuse. Both retained and LTFU women perceived that integrated HIV services increased the risk of disclosure. Retention was influenced by multiple factors for PPHIV. Stigma and fear of disclosure were prominent barriers for LTFU women. Multicomponent interventions and refining the structure and efficiency of PMTCT services may enhance retention for PPHIV.Item A Retrospective Cohort Study Examining the Utility of Perinatal Urine Toxicology Testing to Guide Breastfeeding Initiation(Wolters Kluwer, 2021) Harris, Miriam; Joseph, Kathleen; Hoeppner, Bettina; Wachman, Elisha M.; Gray, Jessica R.; Saia, Kelley; Wakeman, Sarah; Bair-Merritt, Megan H.; Schiff, Davida M.; Emergency Medicine, School of MedicineObjective: National guidelines advise against breastfeeding for women who use nonprescribed substances in the third trimester. This reduces the number of women who are supported in breastfeeding initiation despite limited evidence on the prognostic value of third trimester substance use. We sought to examine the degree to which prenatal nonprescribed substance use is associated with non-prescribed use postpartum. Methods: Retrospective cohort study of pregnant women with opioid use disorder on methadone or buprenorphine between 2006 and 2015. Nonprescribed use was defined by a positive urine drug testing (UDT). Sensitivity, specificity, positive predictive value, and negative predictive value were calculated comparing 3 prenatal periods with postpartum UDT results. Generalized estimating equations were used to examine the extent to which prenatal nonprescribed use was associated with postpartum use. Results: Included were 545 deliveries by 503 women. Mean age was 28.3 years, 88% were White/non-Hispanic, 93% had public insurance, and 43% received adequate prenatal care. The predictive value of UDT's 90 to 31 days before delivery, 30 to 0 days before delivery, and at delivery showed low sensitivity (44, 26, 27%, respectively) and positive predictive value (36, 36, 56%, respectively), but higher negative predictive value (80, 85, and 78%, respectively), P-values all <0.05. In the final adjusted model, only nonprescribed use at delivery was significantly associated with postpartum nonprescribed use. Conclusions: Nonprescribed use at delivery was most strongly associated with postpartum use compared with earlier time periods currently prioritized in guidelines. In women with opioid use disorder prenatal UDT results alone are insufficient to guide breastfeeding decisions.Item Abortion Restrictions and the Impact on Families(American Medical Association, 2024) Wilkinson, Tracey A.; Bernard, Caitlin; Pediatrics, School of MedicineItem Abortion-Related Laws and Concurrent Patterns in Abortion Incidence in Indiana, 2010-2019(American Public Health Association, 2023) Moseson, Heidi; Smith, Mikaela H.; Chakraborty, Payal; Gyuras, Hillary J.; Foster, Abigail; Bessett, Danielle; Wilkinson, Tracey A.; Norris, Alison H.; Pediatrics, School of MedicineObjectives: To analyze abortion incidence in Indiana concurrent with changes in abortion-related laws. Methods: Using publicly available data, we created a timeline of abortion-related laws in Indiana, calculated abortion rates by geography, and described changes in abortion occurrence coincident with changes in abortion-related laws between 2010 and 2019. Results: Between 2010 and 2019, Indiana’s legislature passed 14 abortion-restricting laws, and 4 of 10 abortion-providing clinics closed. The Indiana abortion rate decreased from 7.8 abortions per 1000 women aged 15 to 44 years in 2010 to 5.9 in 2019. At all time points, the abortion rate was 58% to 71% of the Midwestern rate and 48% to 55% of the national rate. By 2019, nearly 1 in 3 (29%) Indiana residents who obtained abortion care did so outside the state. Conclusions: Access to abortion in Indiana over the past decade was low, required increases in interstate travel to obtain care, and co-occurred with the passage of numerous abortion restrictions. Public Health Implications: These findings preview unequal abortion access and increases in interstate travel as state-level restrictions and bans go into effect across the country.Item Accuracy of Chest Computed Tomography in Distinguishing Cystic Pleuropulmonary Blastoma From Benign Congenital Lung Malformations in Children(American Medical Association, 2022-06-01) Engwall-Gill, Abigail J.; Chan, Sherwin S.; Boyd, Kevin P.; Saito, Jacqueline M.; Fallat, Mary E.; St. Peter, Shawn D.; Bolger-Theut, Stephanie; Crotty, Eric J.; Green, Jared R.; Hulett Bowling, Rebecca L.; Kumbhar, Sachin S.; Rattan, Mantosh S.; Young, Cody M.; Canner, Joseph K.; Deans, Katherine J.; Gadepalli, Samir K.; Helmrath, Michael A.; Hirschl, Ronald B.; Kabre, Rashmi; Lal, Dave R.; Landman, Matthew P.; Leys, Charles M.; Mak, Grace Z.; Minneci, Peter C.; Wright, Tiffany N.; Kunisaki, Shaun M.; Midwest Pediatric Surgery Consortium; Surgery, School of MedicineImportance: The ability of computed tomography (CT) to distinguish between benign congenital lung malformations and malignant cystic pleuropulmonary blastomas (PPBs) is unclear. Objective: To assess whether chest CT can detect malignant tumors among postnatally detected lung lesions in children. Design, setting, and participants: This retrospective multicenter case-control study used a consortium database of 521 pathologically confirmed primary lung lesions from January 1, 2009, through December 31, 2015, to assess diagnostic accuracy. Preoperative CT scans of children with cystic PPB (cases) were selected and age-matched with CT scans from patients with postnatally detected congenital lung malformations (controls). Statistical analysis was performed from January 18 to September 6, 2020. Preoperative CT scans were interpreted independently by 9 experienced pediatric radiologists in a blinded fashion and analyzed from January 24, 2019, to September 6, 2020. Main outcomes and measures: Accuracy, sensitivity, and specificity of CT in correctly identifying children with malignant tumors. Results: Among 477 CT scans identified (282 boys [59%]; median age at CT, 3.6 months [IQR, 1.2-7.2 months]; median age at resection, 6.9 months [IQR, 4.2-12.8 months]), 40 cases were extensively reviewed; 9 cases (23%) had pathologically confirmed cystic PPB. The median age at CT was 7.3 months (IQR, 2.9-22.4 months), and median age at resection was 8.7 months (IQR, 5.0-24.4 months). The sensitivity of CT for detecting PPB was 58%, and the specificity was 83%. High suspicion for malignancy correlated with PPB pathology (odds ratio, 13.5; 95% CI, 2.7-67.3; P = .002). There was poor interrater reliability (κ = 0.36 [range, 0.06-0.64]; P < .001) and no significant difference in specific imaging characteristics between PPB and benign cystic lesions. The overall accuracy rate for distinguishing benign vs malignant lesions was 81%. Conclusions and relevance: This study suggests that chest CT, the current criterion standard imaging modality to assess the lung parenchyma, may not accurately and reliably distinguish PPB from benign congenital lung malformations in children. In any cystic lung lesion without a prenatal diagnosis, operative management to confirm pathologic diagnosis is warranted.Item Achieving UNAIDS 90-90-90 targets for pregnant and postpartum women in sub-Saharan Africa: progress, gaps and research needs(Mediscript, 2018-11-15) Abuogi, Lisa L.; Humphrey, John M.; Mpody, Christian; Yotebieng, Marcel; Murnane, Pamela M.; Clouse, Kate; Otieno, Lindah; Cohen, Craig R.; Wools-Kaloustian, Kara; Medicine, School of MedicineThe implementation of the 2013 World Health Organization Option B+ recommendations for HIV treatment during pregnancy has helped drive significant progress in achieving universal treatment for pregnant and postpartum women in sub-Saharan Africa (SSA). Yet, critical research and implementation gaps exist in achieving the UNAIDS 90-90-90 targets. To help guide researchers, programmers and policymakers in prioritising these areas, we undertook a comprehensive review of the progress, gaps and research needs to achieve the 90-90-90 targets for this population in the Option B+ era, including early infant HIV diagnosis (EID) for HIV-exposed infants. Salient areas where progress has been achieved or where gaps remain include: (1) knowledge of HIV status is higher among people with HIV in southern and eastern Africa compared to western and central Africa (81% versus 48%, UNAIDS); (2) access to antiretroviral therapy (ART) for pregnant women has doubled in 22 of 42 SSA countries, but only six have achieved the second 90, and nearly a quarter of pregnant women initiating ART become lost to follow-up; (3) viral suppression data for this population are sparse (estimates range from 30% to 98% peripartum), with only half of women maintaining suppression through 12 months postpartum; and (4) EID rates range from 15% to 62%, with only three of 21 high-burden SSA countries testing >50% HIV-exposed infants within the first 2 months of life. We have identified and outlined promising innovations and research designed to address these gaps and improve the health of pregnant and postpartum women living with HIV and their infants.