{"title":"Challenges in Antenatal Care (2024-002JMWH)","authors":"","doi":"10.1111/jmwh.13718","DOIUrl":"10.1111/jmwh.13718","url":null,"abstract":"","PeriodicalId":16468,"journal":{"name":"Journal of midwifery & women's health","volume":"69 6","pages":"985-987"},"PeriodicalIF":2.1,"publicationDate":"2024-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142788219","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lauren Taylor Narbey CNM, MSN, WHNP-BC, Alice Curtis Cline CNM, MSN
Introduction
Perinatal substance use continues to rise across the United States presenting unique challenges to providing antepartum care. Polysubstance use, limited and late engagement in health care, co-occurring mood disorders, and several social barriers are well documented. This review seeks to summarize these barriers and present novel approaches to caring for this high-risk population.
Methods
Inclusion criteria for this study focused on peer-reviewed articles that explicitly detailed a direct impact on the provision or receipt of antenatal care in the setting of substance use within the United States that were published in the last 5 years. PubMed and Web of Science were used to find applicable articles. Of the 156 articles found, 10 relevant articles were selected for the final empirical integrative review that entailed data evaluation using the Mixed Methods Appraisal Tool (MMAT) and thematic analysis.
Results
10 review articles met inclusion; 3 were qualitative, 6 were quantitative and nonrandomized, and one was quantitative descriptive. Six articles met MMAT quality criteria, and there were significant limitations in every article. Topics included opioid use disorder (n = 6), general substance use (n = 3), and tobacco use (n = 1). Themes included integrated models of prenatal care, colocated care, resource coordination, and peer support along with the role of the perinatal health care professional and consistent use of a substance use screening tool.
Discussion
A comprehensive and multidisciplinary care model is necessary to meet the complex and urgent needs of individuals with perinatal substance use that not only meets recommendations for opioid maintenance therapy or substance use cessation but the important areas of accessibility and interpersonal support. Future research should focus on the development, implementation, and evaluation of new models of care for this vulnerable population.
{"title":"Challenges for Antepartum Care of the Individual with Perinatal Substance Use: An Empirical Integrative Review of Novel Approaches to Improve Care","authors":"Lauren Taylor Narbey CNM, MSN, WHNP-BC, Alice Curtis Cline CNM, MSN","doi":"10.1111/jmwh.13714","DOIUrl":"10.1111/jmwh.13714","url":null,"abstract":"<div>\u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Perinatal substance use continues to rise across the United States presenting unique challenges to providing antepartum care. Polysubstance use, limited and late engagement in health care, co-occurring mood disorders, and several social barriers are well documented. This review seeks to summarize these barriers and present novel approaches to caring for this high-risk population.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Inclusion criteria for this study focused on peer-reviewed articles that explicitly detailed a direct impact on the provision or receipt of antenatal care in the setting of substance use within the United States that were published in the last 5 years. PubMed and Web of Science were used to find applicable articles. Of the 156 articles found, 10 relevant articles were selected for the final empirical integrative review that entailed data evaluation using the Mixed Methods Appraisal Tool (MMAT) and thematic analysis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>10 review articles met inclusion; 3 were qualitative, 6 were quantitative and nonrandomized, and one was quantitative descriptive. Six articles met MMAT quality criteria, and there were significant limitations in every article. Topics included opioid use disorder (n = 6), general substance use (n = 3), and tobacco use (n = 1). Themes included integrated models of prenatal care, colocated care, resource coordination, and peer support along with the role of the perinatal health care professional and consistent use of a substance use screening tool.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Discussion</h3>\u0000 \u0000 <p>A comprehensive and multidisciplinary care model is necessary to meet the complex and urgent needs of individuals with perinatal substance use that not only meets recommendations for opioid maintenance therapy or substance use cessation but the important areas of accessibility and interpersonal support. Future research should focus on the development, implementation, and evaluation of new models of care for this vulnerable population.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16468,"journal":{"name":"Journal of midwifery & women's health","volume":"69 6","pages":"863-874"},"PeriodicalIF":2.1,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11622359/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142741897","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ellen L. Tilden CNM, PhD, Taylor Shank PhD, Catherine Polan Orzech MA LMFT, Leah R. Holmes BA, Ravyn Granados BA, Sayehsadat Moosavisahebozamani MS, David Starr MBA, Aaron B. Caughey PhD, MD, Alice M. Graham PhD, Kristen L. Mackiewicz Seghete PhD
Introduction
Perinatal depression is a leading cause of preventable US maternal morbidity and mortality. Although Mindfulness-Based Cognitive Therapy for Perinatal Depression (MBCT-PD) is highly effective, it faces significant scalability challenges. Center M, a brief, group-based, mindfulness-based cognitive behavioral therapy (CBT) intervention, is an adaptation of MBCT-PD designed to overcome these challenges. The purpose of this pilot study was to evaluate Center M's preliminary acceptability, feasibility, mechanisms of action, and efficacy.
Methods
In this mixed-methods pilot study, data were collected from 99 pregnant people at 3 time points: preintervention, postintervention, and 6-weeks postpartum (Clinical Trials no. NCT06525922). Participants engaged in 4 one-hour, weekly group telehealth Center M sessions facilitated by social workers. Participants strengthened mindfulness CBT skills using home practice materials between group sessions. Data included self-report measures evaluating depressive symptoms, mindfulness skills, and emotion regulation. Satisfaction was assessed via focus groups or surveys.
Results
Depressive symptoms significantly decreased preintervention to postintervention (Patient Health Questionnaire-8 score: preintervention mean [SD] 5.02 [3.52], postintervention mean [SD] 4.23 [2.84]; P = .03), and mindfulness capacity significantly increased preintervention to 6 weeks postpartum (Five Facets of Mindfulness Questionnaire score: preintervention mean [SD] 125.56 [18.68], 6 weeks postpartum mean [SD] 130.10 [17.15]; P = .004). Linear regression analyses indicate that higher mindfulness at 6 weeks postpartum significantly predicted fewer depression symptoms at 6 weeks postpartum (β, −0.07; 95% CI, −0.123 to −0.021, R2 = 0.22; P = .006). Reduction in the use of maladaptive emotion regulation was significantly associated with decreased depressive symptoms at 6 weeks postpartum (β, 0.21; 95% CI, 0.048 to 0.376, R2 = .21; P = .012). Qualitative themes indicated high Center M acceptability and appeal.
Discussion
Our findings support the feasibility, acceptability, and appeal of Center M. Results suggest Center M may be effective in reducing depression and enhancing mindfulness skills. Future research must confirm these initial findings to more widely address Center M implementation capacity and sustainability.
导言：围产期抑郁症是导致美国孕产妇发病率和死亡率的主要原因。基于正念的围产期抑郁症认知疗法（MBCT-PD）虽然非常有效，但在推广方面却面临着巨大的挑战。Center M 是一种基于正念的认知行为疗法 (CBT) 干预，是对 MBCT-PD 的改良，旨在克服这些挑战。本试点研究旨在评估 Center M 的初步可接受性、可行性、作用机制和疗效：在这项混合方法试点研究中，收集了 99 名孕妇在 3 个时间点的数据：干预前、干预后和产后 6 周（临床试验编号：NCT06525922）。参与者在社工的协助下每周参加 4 次为期一小时的远程保健中心 M 小组会议。参与者在小组课间使用家庭练习材料加强正念 CBT 技能。数据包括评估抑郁症状、正念技能和情绪调节的自我报告测量。满意度通过焦点小组或调查进行评估：从干预前到干预后，抑郁症状明显减轻（患者健康问卷-8 评分：干预前平均值 [SD] 5.02 [3.52]，干预后平均值 [SD] 4.23 [2.84]；P = .03），正念能力从干预前到产后 6 周明显提高（正念五方面问卷评分：干预前平均值 [SD] 125.56 [18.68]，产后 6 周平均值 [SD] 130.10 [17.15]；P = .004）。线性回归分析表明，产后 6 周时较高的正念水平可显著预测产后 6 周时较少的抑郁症状（β，-0.07；95% CI，-0.123 至 -0.021，R2 = 0.22；P = .006）。减少使用适应不良的情绪调节与产后 6 周抑郁症状的减少有显著相关性（β，0.21；95% CI，0.048 至 0.376，R2 = 0.21；P = 0.012）。定性主题表明中心 M 的可接受性和吸引力都很高：我们的研究结果支持中心 M 的可行性、可接受性和吸引力。研究结果表明，中心 M 可以有效减少抑郁和提高正念技能。未来的研究必须证实这些初步发现，以更广泛地解决中心 M 的实施能力和可持续性问题。
{"title":"Center M Pilot Trial: Integrating Preventive Mental Health Care in Routine Prenatal Care","authors":"Ellen L. Tilden CNM, PhD, Taylor Shank PhD, Catherine Polan Orzech MA LMFT, Leah R. Holmes BA, Ravyn Granados BA, Sayehsadat Moosavisahebozamani MS, David Starr MBA, Aaron B. Caughey PhD, MD, Alice M. Graham PhD, Kristen L. Mackiewicz Seghete PhD","doi":"10.1111/jmwh.13709","DOIUrl":"10.1111/jmwh.13709","url":null,"abstract":"<div>\u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Perinatal depression is a leading cause of preventable US maternal morbidity and mortality. Although Mindfulness-Based Cognitive Therapy for Perinatal Depression (MBCT-PD) is highly effective, it faces significant scalability challenges. Center M, a brief, group-based, mindfulness-based cognitive behavioral therapy (CBT) intervention, is an adaptation of MBCT-PD designed to overcome these challenges. The purpose of this pilot study was to evaluate Center M's preliminary acceptability, feasibility, mechanisms of action, and efficacy.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>In this mixed-methods pilot study, data were collected from 99 pregnant people at 3 time points: preintervention, postintervention, and 6-weeks postpartum (Clinical Trials no. NCT06525922). Participants engaged in 4 one-hour, weekly group telehealth Center M sessions facilitated by social workers. Participants strengthened mindfulness CBT skills using home practice materials between group sessions. Data included self-report measures evaluating depressive symptoms, mindfulness skills, and emotion regulation. Satisfaction was assessed via focus groups or surveys.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Depressive symptoms significantly decreased preintervention to postintervention (Patient Health Questionnaire-8 score: preintervention mean [SD] 5.02 [3.52], postintervention mean [SD] 4.23 [2.84]; <i>P</i> = .03), and mindfulness capacity significantly increased preintervention to 6 weeks postpartum (Five Facets of Mindfulness Questionnaire score: preintervention mean [SD] 125.56 [18.68], 6 weeks postpartum mean [SD] 130.10 [17.15]; <i>P</i> = .004). Linear regression analyses indicate that higher mindfulness at 6 weeks postpartum significantly predicted fewer depression symptoms at 6 weeks postpartum (β, −0.07; 95% CI, −0.123 to −0.021, <i>R<sup>2</sup></i> = 0.22; <i>P</i> = .006). Reduction in the use of maladaptive emotion regulation was significantly associated with decreased depressive symptoms at 6 weeks postpartum (β, 0.21; 95% CI, 0.048 to 0.376, <i>R<sup>2</sup></i> = .21; <i>P</i> = .012). Qualitative themes indicated high Center M acceptability and appeal.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Discussion</h3>\u0000 \u0000 <p>Our findings support the feasibility, acceptability, and appeal of Center M. Results suggest Center M may be effective in reducing depression and enhancing mindfulness skills. Future research must confirm these initial findings to more widely address Center M implementation capacity and sustainability.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16468,"journal":{"name":"Journal of midwifery & women's health","volume":"69 6","pages":"906-916"},"PeriodicalIF":2.1,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142735462","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sueny P. Lima dos Santos MS, Eric E. Calloway PhD, RDN, Ilana R. A. Chertok PhD, MSN, RN, IBCLC, Zelalem T. Haile PhD, MPH
Introduction
Preterm birth and small for gestational age (SGA) are significant public health concerns in the United States, with pronounced disparities across racial and ethnic groups. Traditional prenatal care adequacy indices have limitations in fully capturing their multifaceted nature. Our study introduces the Comprehensive Prenatal Care Index (CPCI) to provide a more holistic assessment of prenatal care by integrating key elements of prenatal counseling and health promotion.
Methods
This cross-sectional study used the Pregnancy Risk Assessment Monitoring System 2016-2021 data. The CPCI was developed based on a comprehensive literature review, incorporating components such as timing, frequency, and content of prenatal visits. The index was validated using Item Response Theory (IRT) and compared with the Kotelchuck and Kessner Indices.
Results
The study included 139,181 pregnant women. The CPCI demonstrated strong internal consistency (Cronbach's α, 0.75; ω total, 0.81). IRT analysis confirmed the index's ability to capture variability in the quality of prenatal care, with item difficulty parameters ranging from −2.93 to +2.10. CPCI scores were significantly associated with reduced odds of adverse birth outcomes. Adequate CPCI care was linked to a 63% reduction in the odds of preterm birth among non-Hispanic White women, with similar reductions observed in Hispanic women (odds ratio [OR], 0.59) and Asian women (OR, 0.38). For SGA, adequate care was protective among non-Hispanic White (OR, 0.86) and Hispanic women (OR, 0.82) but showed mixed results in other groups.
Discussion
The CPCI provides a more inclusive measure of the quality of prenatal care compared with traditional indices. The study's findings suggest a significant role of comprehensive prenatal care in reducing adverse birth outcomes and addressing racial and ethnic disparities. Future research should focus on refining the CPCI and exploring its applicability in diverse populations to inform targeted and culturally sensitive prenatal care strategies.
{"title":"Development and Testing of the Comprehensive Prenatal Care Index: Relationship With Preterm Birth and Small for Gestational Age Across Racial and Ethnic Groups","authors":"Sueny P. Lima dos Santos MS, Eric E. Calloway PhD, RDN, Ilana R. A. Chertok PhD, MSN, RN, IBCLC, Zelalem T. Haile PhD, MPH","doi":"10.1111/jmwh.13707","DOIUrl":"10.1111/jmwh.13707","url":null,"abstract":"<div>\u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Preterm birth and small for gestational age (SGA) are significant public health concerns in the United States, with pronounced disparities across racial and ethnic groups. Traditional prenatal care adequacy indices have limitations in fully capturing their multifaceted nature. Our study introduces the Comprehensive Prenatal Care Index (CPCI) to provide a more holistic assessment of prenatal care by integrating key elements of prenatal counseling and health promotion.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This cross-sectional study used the Pregnancy Risk Assessment Monitoring System 2016-2021 data. The CPCI was developed based on a comprehensive literature review, incorporating components such as timing, frequency, and content of prenatal visits. The index was validated using Item Response Theory (IRT) and compared with the Kotelchuck and Kessner Indices.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The study included 139,181 pregnant women. The CPCI demonstrated strong internal consistency (Cronbach's α, 0.75; ω total, 0.81). IRT analysis confirmed the index's ability to capture variability in the quality of prenatal care, with item difficulty parameters ranging from −2.93 to +2.10. CPCI scores were significantly associated with reduced odds of adverse birth outcomes. Adequate CPCI care was linked to a 63% reduction in the odds of preterm birth among non-Hispanic White women, with similar reductions observed in Hispanic women (odds ratio [OR], 0.59) and Asian women (OR, 0.38). For SGA, adequate care was protective among non-Hispanic White (OR, 0.86) and Hispanic women (OR, 0.82) but showed mixed results in other groups.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Discussion</h3>\u0000 \u0000 <p>The CPCI provides a more inclusive measure of the quality of prenatal care compared with traditional indices. The study's findings suggest a significant role of comprehensive prenatal care in reducing adverse birth outcomes and addressing racial and ethnic disparities. Future research should focus on refining the CPCI and exploring its applicability in diverse populations to inform targeted and culturally sensitive prenatal care strategies.</p>\u0000 </section>\u0000 </div>","PeriodicalId":16468,"journal":{"name":"Journal of midwifery & women's health","volume":"69 6","pages":"917-928"},"PeriodicalIF":2.1,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11622361/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142734969","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Carrie J. Henry CNM, PhD, RN, Denise Côté-Arsenault PhD, RN, CPLC
Trisomy 18 (T18) is the second-most common autosomal trisomy and includes multiple anomalies, growth restriction, and a severely shortened life span, often lasting only hours or days. Côté-Arsenault and Denney-Koelsch extended Reva Rubin's work, describing the psychosocial stages of pregnancy by describing the stages and developmental tasks for a pregnancy altered by a life-limiting fetal condition such as T18. When a diagnosis of T18 is made prenatally, the pregnancy changes dramatically, although it remains a psychosocial developmental process. The extended stages of pregnancy with T18 or another life-limiting fetal condition are: Pre-Diagnosis, Learning the Diagnosis, Living With the Diagnosis, Birth and Death, and Post Death. As they navigate these stages, parents must also address 7 developmental tasks of pregnancy, which are (1) Navigating Relationships, (2) Comprehending Implications of the Condition, (3) Revising Goals of Pregnancy, (4) Making the Most of Time With Baby, (5) Preparing for Birth and Inevitable Death, (6) Advocating for Baby With Integrity, and (7) Adjusting to Life in Absence of Baby. Knowledgeable health care providers can do much more than support parents through grief and facilitate discussions about birth planning. This case report highlights the importance of a knowledgeable provider who can help parents navigate the stages and tasks of pregnancy, empowering them to make choices consistent with their values so they have no regrets.
{"title":"Family-Centered Antenatal Care With a Life-Limiting Fetal Condition: A Developmental Theory-Guided Approach","authors":"Carrie J. Henry CNM, PhD, RN, Denise Côté-Arsenault PhD, RN, CPLC","doi":"10.1111/jmwh.13710","DOIUrl":"10.1111/jmwh.13710","url":null,"abstract":"<p>Trisomy 18 (T18) is the second-most common autosomal trisomy and includes multiple anomalies, growth restriction, and a severely shortened life span, often lasting only hours or days. Côté-Arsenault and Denney-Koelsch extended Reva Rubin's work, describing the psychosocial stages of pregnancy by describing the stages and developmental tasks for a pregnancy altered by a life-limiting fetal condition such as T18. When a diagnosis of T18 is made prenatally, the pregnancy changes dramatically, although it remains a psychosocial developmental process. The extended stages of pregnancy with T18 or another life-limiting fetal condition are: <i>Pre-Diagnosis, Learning the Diagnosis, Living With the Diagnosis, Birth and Death</i>, and <i>Post Death</i>. As they navigate these stages, parents must also address 7 developmental tasks of pregnancy, which are (1) <i>Navigating Relationships</i>, (2) <i>Comprehending Implications of the Condition</i>, (3) <i>Revising Goals of Pregnancy</i>, (4) <i>Making the Most of Time With Baby</i>, (5) <i>Preparing for Birth and Inevitable Death</i>, (6) <i>Advocating for Baby With Integrity</i>, and (7) <i>Adjusting to Life in Absence of Baby</i>. Knowledgeable health care providers can do much more than support parents through grief and facilitate discussions about birth planning. This case report highlights the importance of a knowledgeable provider who can help parents navigate the stages and tasks of pregnancy, empowering them to make choices consistent with their values so they have no regrets.</p>","PeriodicalId":16468,"journal":{"name":"Journal of midwifery & women's health","volume":"69 6","pages":"958-962"},"PeriodicalIF":2.1,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142717882","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Research and Professional Literature to Inform Practice, November/December 2024","authors":"Rebecca R. S. Clark CNM, PhD, MSN, RN","doi":"10.1111/jmwh.13712","DOIUrl":"10.1111/jmwh.13712","url":null,"abstract":"","PeriodicalId":16468,"journal":{"name":"Journal of midwifery & women's health","volume":"69 6","pages":"963-968"},"PeriodicalIF":2.1,"publicationDate":"2024-11-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142712234","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Melissa D. Avery CNM, PhD, Linda A. Hunter CNM, EdD, Ira Kantrowitz-Gordon CNM, PhD
<p>The <i>Journal of Midwifery & Women's Health</i> (<i>JMWH</i>) leadership strives to ensure the highest level of scholarly publication, including consistency with national and international guidance related to scientific integrity and excellence. Since July 1, 2005, the International Committee of Medical Journal Editors (ICMJE) has recommended registration of all clinical trials.<span><sup>1</sup></span> Clinical trial registration is necessary for study results to be published in journals that adhere to the ICMJE guidelines. Thus, investigators are responsible for ensuring their trials have been appropriately registered. <i>JMWH</i> has a long history of commitment to following these recommendations.<span><sup>2</sup></span> Some authors, however, may be unaware of the requirements. Therefore, the background and current standards are reviewed here.</p><p>What is clinical trial registration and why is it important? The purposes of registration of clinical trials in a national or international database are transparency and reporting integrity. When clinical trial information is publicly available before participant enrollment, individuals interested in trial participation can search opportunities in available registry databases. Researchers can search ongoing trials in their area of study to avoid unnecessary duplication. Clinical trial registration aims to prevent bias in the reporting of research such as only reporting selected outcomes. Trial registries can also be helpful to institutional review boards that are examining newly proposed studies.<span><sup>3</sup></span></p><p>Clinical trials are defined by ICMJE as “any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the relationship between a health-related intervention <i>and</i> a health outcome.”<span><sup>3</sup></span><sup>(p 1)</sup> The treatment or intervention may be pharmacologic, surgical, behavioral, dietary, educational, or changes in care processes. Feasibility type studies that assign participants to a single treatment without a control or comparison group are also considered clinical trials for the purpose of trial registration.<span><sup>3</sup></span> Examination of the clinical trial registration date can assure the public that information was provided to the registry before enrollment of participants, which is essential to preventing bias in reporting.</p><p>Registration of a clinical trial involves investigators providing specific information about the trial to an approved registry.<span><sup>4</sup></span> For example, Clinicaltrials.gov is a trial registry database maintained by the National Library of Medicine and contains information about trials conducted in the United States and many other countries. The World Health Organization (WHO) requires a specific set of items about trials to be included, such as a unique trial identifier (assigned by the regis
{"title":"Building Integrity and Trust in Clinical Trials","authors":"Melissa D. Avery CNM, PhD, Linda A. Hunter CNM, EdD, Ira Kantrowitz-Gordon CNM, PhD","doi":"10.1111/jmwh.13719","DOIUrl":"10.1111/jmwh.13719","url":null,"abstract":"<p>The <i>Journal of Midwifery & Women's Health</i> (<i>JMWH</i>) leadership strives to ensure the highest level of scholarly publication, including consistency with national and international guidance related to scientific integrity and excellence. Since July 1, 2005, the International Committee of Medical Journal Editors (ICMJE) has recommended registration of all clinical trials.<span><sup>1</sup></span> Clinical trial registration is necessary for study results to be published in journals that adhere to the ICMJE guidelines. Thus, investigators are responsible for ensuring their trials have been appropriately registered. <i>JMWH</i> has a long history of commitment to following these recommendations.<span><sup>2</sup></span> Some authors, however, may be unaware of the requirements. Therefore, the background and current standards are reviewed here.</p><p>What is clinical trial registration and why is it important? The purposes of registration of clinical trials in a national or international database are transparency and reporting integrity. When clinical trial information is publicly available before participant enrollment, individuals interested in trial participation can search opportunities in available registry databases. Researchers can search ongoing trials in their area of study to avoid unnecessary duplication. Clinical trial registration aims to prevent bias in the reporting of research such as only reporting selected outcomes. Trial registries can also be helpful to institutional review boards that are examining newly proposed studies.<span><sup>3</sup></span></p><p>Clinical trials are defined by ICMJE as “any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the relationship between a health-related intervention <i>and</i> a health outcome.”<span><sup>3</sup></span><sup>(p 1)</sup> The treatment or intervention may be pharmacologic, surgical, behavioral, dietary, educational, or changes in care processes. Feasibility type studies that assign participants to a single treatment without a control or comparison group are also considered clinical trials for the purpose of trial registration.<span><sup>3</sup></span> Examination of the clinical trial registration date can assure the public that information was provided to the registry before enrollment of participants, which is essential to preventing bias in reporting.</p><p>Registration of a clinical trial involves investigators providing specific information about the trial to an approved registry.<span><sup>4</sup></span> For example, Clinicaltrials.gov is a trial registry database maintained by the National Library of Medicine and contains information about trials conducted in the United States and many other countries. The World Health Organization (WHO) requires a specific set of items about trials to be included, such as a unique trial identifier (assigned by the regis","PeriodicalId":16468,"journal":{"name":"Journal of midwifery & women's health","volume":"69 6","pages":"819-820"},"PeriodicalIF":2.1,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jmwh.13719","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142693985","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
<p>Prenatal alcohol exposure is a leading cause of preventable birth defects and developmental problems. There is no known safe amount of alcohol you can drink during pregnancy or while trying to get pregnant. Too many people continue to drink during pregnancy. About 1 in 10 pregnant people in the United States drank alcohol in the past 30 days. About 1 in 22 pregnant people in the United States had 4 or more drinks at one time (binge drinking) in the past 30 days. These problems are completely preventable if a person does not drink alcohol during pregnancy. Why take the risk?</p><p>Drinking alcohol during pregnancy can cause miscarriage, stillbirth, preterm birth, and sudden infant death syndrome (SIDS) and a range of physical, behavioral, and intellectual disabilities for the baby that can last a lifetime. These disabilities are known as fetal alcohol spectrum disorders (FASDs). Some of the health and other problems of people with FASDs include learning disabilities, hyperactivity, difficulty with attention, speech and language delays, intellectual disabilities, and poor reasoning (thinking) and judgment skills. People born with FASDs can also have problems with their organs, including the heart and kidneys. Some babies with FASDs can have a smaller head, weigh less than other babies, and have parts of their faces that look different than other babies.</p><p>There is no known safe amount of alcohol use during pregnancy or when you are trying to get pregnant. Alcohol is passed through the placenta and the fetus is exposed to the same amount as the pregnant person. All exposure to any drinks with alcohol can affect a baby's growth and development and cause FASDs. A 5-ounce glass of wine has the same amount of alcohol as a 12-ounce can of beer or a 1.5-ounce shot of straight liquor. All types of alcohol—even wine, wine coolers, seltzers, hard cider and beer—can harm your developing baby. The Chart on the following page shows when your baby is developing different parts of its body that may be harmed by drinking alcohol.</p><p></p><p>It is best to stop drinking alcohol when you start trying to get pregnant. Many people become pregnant and do not know it right away. It may be up to 4 to 6 weeks before you know for sure that you are pregnant. This means you might be drinking and exposing your developing baby to alcohol without meaning to. If you think you have a problem with alcohol, it's best to get treatment before you try to get pregnant.</p><p>If you drank before you knew you were pregnant or before you knew it could harm your baby, stop now. The less exposure, the better for your baby. If you are having trouble quitting drinking, ask your health care provider for help. There are many treatment options that can help and are safe in pregnancy. Together, you can develop a plan to quit drinking.</p><p>Flesch Kincaid 7.3</p><p>Approved October 2024. This handout replaces “Alcohol in Pregnancy” published in Volume 60, Issue 1, January/February 2015.</
{"title":"Alcohol Use in Pregnancy","authors":"","doi":"10.1111/jmwh.13717","DOIUrl":"10.1111/jmwh.13717","url":null,"abstract":"<p>Prenatal alcohol exposure is a leading cause of preventable birth defects and developmental problems. There is no known safe amount of alcohol you can drink during pregnancy or while trying to get pregnant. Too many people continue to drink during pregnancy. About 1 in 10 pregnant people in the United States drank alcohol in the past 30 days. About 1 in 22 pregnant people in the United States had 4 or more drinks at one time (binge drinking) in the past 30 days. These problems are completely preventable if a person does not drink alcohol during pregnancy. Why take the risk?</p><p>Drinking alcohol during pregnancy can cause miscarriage, stillbirth, preterm birth, and sudden infant death syndrome (SIDS) and a range of physical, behavioral, and intellectual disabilities for the baby that can last a lifetime. These disabilities are known as fetal alcohol spectrum disorders (FASDs). Some of the health and other problems of people with FASDs include learning disabilities, hyperactivity, difficulty with attention, speech and language delays, intellectual disabilities, and poor reasoning (thinking) and judgment skills. People born with FASDs can also have problems with their organs, including the heart and kidneys. Some babies with FASDs can have a smaller head, weigh less than other babies, and have parts of their faces that look different than other babies.</p><p>There is no known safe amount of alcohol use during pregnancy or when you are trying to get pregnant. Alcohol is passed through the placenta and the fetus is exposed to the same amount as the pregnant person. All exposure to any drinks with alcohol can affect a baby's growth and development and cause FASDs. A 5-ounce glass of wine has the same amount of alcohol as a 12-ounce can of beer or a 1.5-ounce shot of straight liquor. All types of alcohol—even wine, wine coolers, seltzers, hard cider and beer—can harm your developing baby. The Chart on the following page shows when your baby is developing different parts of its body that may be harmed by drinking alcohol.</p><p></p><p>It is best to stop drinking alcohol when you start trying to get pregnant. Many people become pregnant and do not know it right away. It may be up to 4 to 6 weeks before you know for sure that you are pregnant. This means you might be drinking and exposing your developing baby to alcohol without meaning to. If you think you have a problem with alcohol, it's best to get treatment before you try to get pregnant.</p><p>If you drank before you knew you were pregnant or before you knew it could harm your baby, stop now. The less exposure, the better for your baby. If you are having trouble quitting drinking, ask your health care provider for help. There are many treatment options that can help and are safe in pregnancy. Together, you can develop a plan to quit drinking.</p><p>Flesch Kincaid 7.3</p><p>Approved October 2024. This handout replaces “Alcohol in Pregnancy” published in Volume 60, Issue 1, January/February 2015.</","PeriodicalId":16468,"journal":{"name":"Journal of midwifery & women's health","volume":"69 6","pages":"983-984"},"PeriodicalIF":2.1,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jmwh.13717","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142678101","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
<p>Cytomegalovirus <i>(sy-toh-mega-loh-virus</i>), or CMV, is a common virus that causes cold-like symptoms. It does not harm most people and may cause a few days of sore throat and feeling tired. CMV stays silent in the body and can become active from time to time. There are different types of CMV. If a person catches CMV right before becoming pregnant or during pregnancy, or a previous infection becomes active, their fetus may get CMV. Babies that get CMV during pregnancy are referred to as having congenital CMV, or cCMV.</p><p>About one in every 200 babies born in the United States has cCMV.</p><p>Most babies with cCMV have no signs you can see at birth. About 10–20% of babies born with cCMV will have more serious problems. At birth they may have a low birth weight and/or small head size (microcephaly). They may also have other signs at birth such as hearing loss, feeding difficulties, jaundice, and a purple spotted rash. Congenital CMV can also lead to long-term health problems, like later hearing loss and developmental delay. Common health problems associated with cCMV are listed in the box, below.</p><p>CMV is transmitted through body fluids, like saliva, urine, and semen. People who catch CMV can pass the virus to others for months. Young children, especially those in daycare or preschool, often have CMV in their body fluids. If a pregnant person gets those infected body fluids in their body (e.g. by kissing), they may get CMV and their baby may develop cCMV.</p><p>People who spend time with young children are at a higher risk of catching CMV and having a baby with cCMV. This includes people with young children, and those who work with young children such as daycare workers, teachers, and other health care providers. People who have had CMV can catch it again and pass it to their baby during pregnancy.</p><p>Only one-third of people who catch CMV while pregnant pass it to their baby. Most people who catch CMV while pregnant do not have babies with cCMV.</p><p>Some health care providers may offer routine testing for CMV antibodies at the beginning of the pregnancy. This is to find out if you have ever had a CMV infection, or if you have a current infection. Others may offer testing if you think you may have been exposed, or for those who spend time with young children. Your health care provider may also recommend CMV testing if certain results are seen on ultrasound, such as slow growth, smaller head size, or other signs of infection.</p><p>Your health care provider may recommend some blood tests for antibodies or discuss testing your amniotic fluid. This is to see if your baby has the virus. Ultrasounds can monitor the baby's growth and look for other signs of congenital CMV, like slow growth or small head size.</p><p>There are no known treatments for cCMV during pregnancy. In the United States, anti-viral medication or treatment with immunoglobulins are not recommended. Research has not found these treatments safe or effective for the ba
{"title":"Congenital Cytomegalovirus (CMV)","authors":"","doi":"10.1111/jmwh.13715","DOIUrl":"10.1111/jmwh.13715","url":null,"abstract":"<p>Cytomegalovirus <i>(sy-toh-mega-loh-virus</i>), or CMV, is a common virus that causes cold-like symptoms. It does not harm most people and may cause a few days of sore throat and feeling tired. CMV stays silent in the body and can become active from time to time. There are different types of CMV. If a person catches CMV right before becoming pregnant or during pregnancy, or a previous infection becomes active, their fetus may get CMV. Babies that get CMV during pregnancy are referred to as having congenital CMV, or cCMV.</p><p>About one in every 200 babies born in the United States has cCMV.</p><p>Most babies with cCMV have no signs you can see at birth. About 10–20% of babies born with cCMV will have more serious problems. At birth they may have a low birth weight and/or small head size (microcephaly). They may also have other signs at birth such as hearing loss, feeding difficulties, jaundice, and a purple spotted rash. Congenital CMV can also lead to long-term health problems, like later hearing loss and developmental delay. Common health problems associated with cCMV are listed in the box, below.</p><p>CMV is transmitted through body fluids, like saliva, urine, and semen. People who catch CMV can pass the virus to others for months. Young children, especially those in daycare or preschool, often have CMV in their body fluids. If a pregnant person gets those infected body fluids in their body (e.g. by kissing), they may get CMV and their baby may develop cCMV.</p><p>People who spend time with young children are at a higher risk of catching CMV and having a baby with cCMV. This includes people with young children, and those who work with young children such as daycare workers, teachers, and other health care providers. People who have had CMV can catch it again and pass it to their baby during pregnancy.</p><p>Only one-third of people who catch CMV while pregnant pass it to their baby. Most people who catch CMV while pregnant do not have babies with cCMV.</p><p>Some health care providers may offer routine testing for CMV antibodies at the beginning of the pregnancy. This is to find out if you have ever had a CMV infection, or if you have a current infection. Others may offer testing if you think you may have been exposed, or for those who spend time with young children. Your health care provider may also recommend CMV testing if certain results are seen on ultrasound, such as slow growth, smaller head size, or other signs of infection.</p><p>Your health care provider may recommend some blood tests for antibodies or discuss testing your amniotic fluid. This is to see if your baby has the virus. Ultrasounds can monitor the baby's growth and look for other signs of congenital CMV, like slow growth or small head size.</p><p>There are no known treatments for cCMV during pregnancy. In the United States, anti-viral medication or treatment with immunoglobulins are not recommended. Research has not found these treatments safe or effective for the ba","PeriodicalId":16468,"journal":{"name":"Journal of midwifery & women's health","volume":"69 6","pages":"981-982"},"PeriodicalIF":2.1,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jmwh.13715","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142678105","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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