Obstetrics and Gynecology Commons^™

Nitroglycerine For Retained Placenta: A Meta-Analysis Of Randomized Controlled Trials, Alessandro Petrecca, Gabriele Saccone, Vincenzo Berghella

Department of Obstetrics and Gynecology Faculty Papers

OBJECTIVE: To evaluate the effect of nitroglycerine on placenta delivery after retained placenta.

DESIGN: Systematic review with meta-analysis.

DATA SOURCES: MEDLINE, PROSPERO, Scopus, ClinicalTrials.gov, EMBASE, Sciencedirect, the Cochrane Library, Scielo were searched from their inception until February 2024.

ELIGIBILITY CRITERIA FOR SELECTING STUDIES: We included all randomized clinical trials comparing use of nitroglycerine (i.e. intervention group) with placebo or with no treatment (i.e. control group) given for retained placenta after vaginal delivery.

DATA SYNTHESIS: The primary outcome was rate of manual removal of the placenta. The summary measures were reported as relative risk (RR) or as mean difference (MD) with …

What Is The Evidence? Updates In The Use Of Antenatal Corticosteroids For Patients At Risk Of Preterm Birth, Moti Gulersen, Cynthia Gyamfi-Bannerman

Department of Obstetrics and Gynecology Faculty Papers

Antenatal corticosteroids have long been considered one of the most important antenatal therapies available for pregnant patients at risk of preterm birth based on the associated reduction of neonatal morbidity and mortality following their administration. However, despite decades of research since their incorporation into routine clinical practice, a number of key questions related to antenatal corticosteroid use remain. These include evaluating the impact of antenatal corticosteroids at gestational ages outside of the previously recommended window of 24 0/7–33 6/7 weeks of gestation, determining factors associated with optimal steroid timing in order to reduce unnecessary exposure, alterations in its dosing regimen, …

Invited Perspective: Climate Change And Maternal Mental Health-Looking Beyond High-Income Countries, Andrea G Buchwald, Sarah Boudova

Department of Obstetrics and Gynecology Faculty Papers

No abstract provided.

The Effectiveness Of Ultrasound-Indicated Cerclage For The Reduction Of Extreme Preterm Birth In Twin Pregnancies With A Short Cervix: A Systematic Review And Meta-Analysis, Lissa Van Gils, Renske Dutilh, Nerissa Denswil, Amanda Roman, Marjon A De Boer, Eva Pajkrt, Martijn A Oudijk

Department of Obstetrics and Gynecology Faculty Papers

OBJECTIVE: This study aimed to evaluate the effectiveness of cervical cerclage in women with a twin pregnancy and a midpregnancy asymptomatic short cervix (≤25 mm), in preventing preterm birth and improving neonatal outcomes.

DATA SOURCES: Systematic searches were conducted in MEDLINE, Embase, Web of Science, Scopus, and Cochrane Library up to April 17, 2023, updated in September and February 2024.

STUDY ELIGIBILITY CRITERIA: Included were randomized controlled trials, cohort studies, and case-control studies comparing cerclage with expectant management in twin pregnancies and an asymptomatic short cervix (≤25 mm).

METHODS: Risk of bias was assessed using the Newcastle-Ottawa Quality Assessment Scale …

Maternal Morbidity Associated With Early Preterm Birth In Low-Risk Singleton Pregnancies, Moti Gulersen, Erez Lenchner, Alisha Goyal, Amos Grunebaum, Frank A. Chervenak, Eran Bornstein

Department of Obstetrics and Gynecology Faculty Papers

Background/Objectives: While neonatal morbidities associated with early preterm birth are known, the risks of maternal morbidities in these births remain unclear. Thus, we set out to assess the risk of maternal morbidities associated with early preterm births. Methods: Retrospective cohort study utilizing the United States (US) Natality Live Birth database from the Centers for Disease Control and Prevention (2016–2021). Low-risk singleton pregnancies were included. High-risk conditions such as out-of-hospital births, fetal anomalies, pregestational and gestational diabetes, and hypertensive disorders of pregnancy were excluded. The rates of several maternal morbidities were compared among three gestational age at birth groups: 23 0/7–27 …

Trustworthiness Criteria For Meta-Analyses Of Randomized Controlled Studies: Obgyn Journal Guidelines., Vincenzo Berghella

Department of Obstetrics and Gynecology Faculty Papers

No abstract provided.

Apixaban Versus Enoxaparin To Prevent Venous Thromboembolism In Post-Operative Patients With Gynecologic Cancers At An Urban Academic Medical Center, Victoria Diamond, Katherine Gerber, Geno J. Merli, Rebecca J. Mercier, Aaron Shafer, Norman G. Rosenblum

Department of Obstetrics and Gynecology Faculty Papers

OBJECTIVE: A recent clinical trial demonstrated that the use of apixaban was safe and equal to enoxaparin (LMWH) in post-operative gynecologic oncology patients. This study aimed to determine if these findings are applicable in a diverse patient population at a single site urban academic medical center.

METHODS: This was a retrospective cohort study of patients who underwent an exploratory laparotomy for confirmed or presumed gynecologic cancer from the years 2017-2023 at a single-site urban academic medical center. Venous thromboembolism (VTE) prophylaxis with LMWH was standard practice at our institution up until January 2021 after which apixaban became standard for post-operative …

Segregation By Payer In Obstetrics And Gynecology Residency Ambulatory Care Sites, Kavita Vinekar, Neena Qasba, Hannah Reiser, Erika Banks, Kavita Arora, Brownsyne Edmonds, Karen George

Department of Obstetrics and Gynecology Faculty Papers

IMPORTANCE: Many teaching hospitals in the US segregate patients by insurance status, with resident clinics primarily composed of publicly insured or uninsured patients and faculty practices seeing privately insured patients. The prevalence of this model in obstetrics and gynecology residencies is unknown.

OBJECTIVES: To examine the prevalence of payer-based segregation in obstetrics and gynecology residency ambulatory care sites nationally and to compare residents' and program directors' perceptions of differences in quality of care between payer-segregated and integrated sites.

DESIGN, SETTING, AND PARTICIPANTS: This national survey study included all 6060 obstetrics and gynecology residents and 293 obstetrics and gynecology residency program …

Cord Blood Troponin I Levels: Biomarker Evidence Of Fetal Cardiac Injury In Intrahepatic Cholestasis Of Pregnancy, Itamar Futterman, Hitangee Jain, Rodney Mclaren, Jonathan Mays

Department of Obstetrics and Gynecology Faculty Papers

BACKGROUND: Intrahepatic cholestasis of pregnancy has been linked to sudden stillbirth. The suddenness of the stillbirths in these cases have led clinicians to suspect that the pathogenesis of stillbirth in women with intrahepatic cholestasis of pregnancy is not related to asphyxia but rather to an undefined etiology. One leading hypothesis relates certain bile acid metabolites to myocardial injury. OBJECTIVE: The purpose of this study was to determine whether cord blood troponin I levels are increased in fetuses born to mothers with a diagnosis of intrahepatic cholestasis of pregnancy. STUDY DESIGN: A prospective, case-control study was performed at a single institution …

Glucose-6-Phosphate Dehydrogenase Deficiency As A Cause For Nonimmune Hydrops Fetalis And Severe Fetal Anemia: A Systematic Review, Neel S. Iyer, Matthew H. Mossayebi, Tracy J. Gao, Lylach Haizler-Cohen, Daniele Di Mascio, Rodney A. Mclaren, Huda B. Al-Kouatly

Department of Obstetrics and Gynecology Faculty Papers

BACKGROUND: Glucose-6-phosphate dehydrogenase (G6PD) deficiency is an X-linked recessive disorder that predisposes individuals to hemolysis due to an inborn error of metabolism. We performed a systematic literature review to evaluate G6PD deficiency as a possible etiology of nonimmune hydrops fetalis (NIHF) and severe fetal anemia.

METHODS: PubMed, OVID Medline, Scopus, and clinicaltrials.gov were queried from inception until 31 April 2023 for all published cases of NIHF and severe fetal anemia caused by G6PD deficiency. Keywords included "fetal edema," "hydrops fetalis," "glucose 6 phosphate dehydrogenase deficiency," and "fetal anemia." Cases with workup presuming G6PD deficiency as an etiology for NIHF and …

Contraception And Menstrual Management In Transmasculine And Gender-Diverse Individuals, Adrian Chiem, Maria Cristina Marcos, Beth I. Schwartz

Department of Obstetrics and Gynecology Faculty Papers

Purpose of Review This review outlines the current evidence on the contraceptive and menstrual management methods that are used for transmasculine or gender-diverse (TGD) individuals, as well as the gaps in the literature for this population.

Recent Findings Contraception and menstrual management continue to be an understudied area in the care of TGD individuals, with much of existing research extrapolated from cisgender populations. Emerging studies have looked at contraceptive and menstrual management choices and outcomes in adolescents and highlight the 52 mg LNG-IUD as an option that is efficacious for both indications, as well as high-dose progestin-only pills for menstrual …

The Effect Of Cervical Pessary On Increasing Gestational Age At Delivery In Twin Pregnancies With Asymptomatic Short Cervix: A Systematic Review And Meta-Analysis Of Randomized Controlled Trials, Amir Hossein Norooznezhad, Nikan Zargarzadeh, Ali Javinani, Seyedeh Maedeh Nabavian, Shohra Qaderi, Shayan Mostafaei, Vincenzo Berghella, Yinka Oyelese, Alireza A. Shamshirsaz

Department of Obstetrics and Gynecology Faculty Papers

OBJECTIVE: The incidence of preterm delivery is much higher in twin pregnancies than in singletons and even higher if a short cervical length is detected in the second trimester. Studies are contradictory regarding the efficacy of a cervical pessary to decrease preterm birth in twin pregnancies and short cervical length. To conduct a systematic review and meta-analysis investigating the efficacy of cervical pessary in prolonging gestation, preventing preterm birth, and reducing adverse neonatal outcomes in twin pregnancies with an asymptomatic short cervix.

DATA SOURCES: PubMed, Scopus, Web of Science, and ClinicalTrials.org were searched for randomized controlled trials from inception to …

Identifying Opportunities For Prevention Of Adverse Outcomes Following Female Genital Fistula Repair: Protocol For A Mixed-Methods Study In Uganda, Alison El Ayadi, Susan Obore, Fred Kirya, Suellen Miller, Abner Korn, Hadija Nalubwama, John Neuhaus, Monica Getahun, Patrick Eyul, Robert Twine, Erin Andrew, Justus Barageine

Department of Obstetrics and Gynecology Faculty Papers

BACKGROUND: Female genital fistula is a traumatic debilitating injury, frequently caused by prolonged obstructed labor, affecting between 500,000-2 million women in lower-resource settings. Vesicovaginal fistula causes urinary incontinence, and other morbidity may occur during fistula development. Women with fistula are stigmatized, limit social and economic engagement, and experience psychiatric morbidity. Improved surgical access has reduced fistula consequences yet post-repair risks impacting quality of life and well-being include fistula repair breakdown or recurrence and ongoing or changing urine leakage or incontinence. Limited evidence on risk factors contributing to adverse outcomes hinders interventions to mitigate adverse events. This study aims to quantify …

Characteristics And Outcomes Of Patients With Pregnancy-Related End-Stage Kidney Disease., Lauren Kucirka, Ana Angarita, Tracy Manuck, Kim Boggess, Vimal Derebail, Mollie Wood, Michelle Meyer, Dorry Segev, Monica Reynolds

Department of Obstetrics and Gynecology Faculty Papers

IMPORTANCE: The incidence of pregnancy-related acute kidney injury is increasing and is associated with significant maternal morbidity including progression to end-stage kidney disease (ESKD). Little is known about characteristics and long-term outcomes of patients who develop pregnancy-related ESKD.

OBJECTIVES: To examine the characteristics and clinical outcomes of patients with pregnancy-related ESKD and to investigate associations between pre-ESKD nephrology care and outcomes.

DESIGN, SETTING, AND PARTICIPANTS: This was a cohort study of 183 640 reproductive-aged women with incident ESKD between January 1, 2000, and November 20, 2020, from the US Renal Data System and maternal data from births captured in the …

Reduced Maternal Immunity And Vertical Transfer Of Immunity Against Sars-Cov-2 Variants Of Concern With Covid-19 Exposure Or Initial Vaccination In Pregnancy., Rupsa Boelig, Sidhartha Chaudhury, Gregory D Gromowski, Sandra Mayer, Jocelyn King, Zubair H Aghai, Elke Bergmann-Leitner

Department of Obstetrics and Gynecology Faculty Papers

INTRODUCTION: As the SARS-CoV-2 pandemic continues to evolve, we face new variants of concern with a concurrent decline in vaccine booster uptake. We aimed to evaluate the difference in immunity gained from the original SARS-CoV-2 mRNA vaccine series in pregnancy versus SARS-CoV-2 exposure during pregnancy against recent variants of concern.

STUDY DESIGN: This is a retrospective analysis of previously collected samples from 192 patients who delivered between February 2021 and August 2021. Participants were categorized as 1) COVID vaccine: mRNA vaccine in pregnancy, 2) COVID-exposed, and 3) controls. The primary outcome was neutralizing capacity against wild-type, Delta, and Omicron-B1 between …

Bioaccumulation Of Non-Essential Trace Elements Detected In Women's Follicular Fluid, Urine, And Plasma Is Associated With Poor Reproductive Outcomes Following Single Euploid Embryo Transfer: A Pilot Study, Andrea Palomar, Roberto Gonzalez-Martin, Alicia Quiñonero, Nuria Pellicer, Rocio Fernandez-Saavedra, Isabel Rucandio, Rodolfo Fernandez-Martinez, Estefania Conde-Vilda, Alberto J. Quejido, Caroline Zuckerman, Christine Whitehead, Richard T. Scott, Francisco Dominguez

Department of Obstetrics and Gynecology Faculty Papers

This study aims to determine the association of non-essential trace elements present in follicular fluid, plasma, and urine with reproductive outcomes of women undergoing intracytoplasmic sperm injection (ICSI), preimplantation genetic testing for aneuploidies (PGT-A) and single frozen euploid embryo transfer (SET/FET). This single-center, prospective cohort study included sixty women undergoing ICSI with PGT-A and SET/FET between 2018 and 2019. Urine, plasma and follicular fluid samples were collected on the vaginal oocyte retrieval day to simultaneously quantify ten non-essential trace elements (i.e., Ba, Sr, Rb, Sn, Ti, Pb, Cd, Hg, Sb, and As). We found several associations between the levels of …

Incarcerated Gravid Uterus - A Systematic Review, Sujatha Narayanamoorthy, Allix Hillebrand, Rakshitha Pendam, Rodney Mclaren

Department of Obstetrics and Gynecology Faculty Papers

Incarcerated gravid uterus (IGU) is a serious complication of pregnancy that leads to adverse obstetric outcomes. The aim of this review was to describe this entity in detail. We also aimed to understand if pregnancies with predisposing risk factors that increase the risk of developing IGU had a difference in their clinical manifestations, treatment, and obstetric outcomes. The PubMed, MEDLINE, Embase, Scopus databases and clinicaltrials.gov were searched from inception to July 2023. Case reports and series that provided all the details of the pregnancy and IGU outcome were included. Study quality and risk of bias were assessed using a tool …

Per Oral Endoscopic Myotomy In Pregnancy, Julie Gomez, Laura Felder, Divya Chalikonda, Alexander Schlachterman, Vincenzo Berghella

Department of Obstetrics and Gynecology Faculty Papers

OBJECTIVE: To report the first successful full-term delivery following Per Oral Endoscopic Myotomy (POEM) performed during pregnancy.

METHODS/BACKGROUND: Achalasia is an esophageal motility disorder characterized by dysphagia, regurgitation, reflux, recurrent vomiting, and weight loss. Achalasia in pregnancy can affect nutritional status of the mother, and subsequently, the child, increasing morbidity and creating potential pregnancy complications. POEM is a novel endoscopic procedure which involves cutting the lower esophageal sphincter to allow food to pass, and is considered a safe and effective management option for achalasia in non-pregnant individuals.

RESULTS: We discuss the case of a patient with achalasia and a prior …

Sars-Cov-2 Covid-19 Infection During Pregnancy And Differential Dna Methylation In Human Cord Blood Cells From Term Neonates, Pedro Urday, Suhita Gayen Nee' Betal, Rochelle Sequeira Gomes, Huda B. Al-Kouatly, Kolawole Solarin, Joanna S.Y. Chan, Dongmei Li, Irfan Rahman, Sankar Addya, Rupsa C. Boelig, Zubair H. Aghai

Department of Obstetrics and Gynecology Faculty Papers

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Residents’ Experience And Training In Obstetric Anal Sphincter Injury Repair In The United States, Sujatha Narayanamoorthy, Kimen Singh Balhotra, Michael Silver, Rodney Mclaren, Elishia Mckay

Department of Obstetrics and Gynecology Faculty Papers

With the reduction in obstetric anal sphincter injuries (OASIS) cases, it is unknown if learning and exposure to their repair is compromised during obstetrics and gynecology (OBGYN) residency in the United States (US). The aim of this study was to evaluate the exposure and confidence level of the US OBGYN residents to OASIS repair. Residents’ education on OASIS repair was also assessed. This was a cross sectional online survey that collected residents’ demographics, characteristics of residency program, the number of deliveries and OASIS repairs performed, the site and technique of OASIS repair, post-repair care provided, residents’ confidence level in OASIS …

Parental Perceptions Of The Hpv Vaccine For Prevention Of Anogenital And Oropharyngeal Cancers, Beth I. Schwartz, Merissa Maccani, Shalini Bansal, Meghan Gannon

Department of Obstetrics and Gynecology Faculty Papers

Background and Objectives

Human papillomavirus (HPV) is implicated in the development of both anogenital and oropharyngeal cancers. Although HPV vaccination prevents the majority of anogenital and head and neck cancers (HNC), vaccination rates remain low, especially among males. Known barriers to vaccination are knowledge gaps and vaccine acceptability. The objective of this study is to explore parental knowledge, perceptions, and decision-making processes about HPV and HPV vaccination for both anogenital and HNC.

Methods

This qualitative study recruited parents of children and adolescents aged 8–18 to participate in semi-structured telephone interviews. Data were analyzed using thematic analyses, informed by an inductive …

Cost-Effectiveness Of Low-Dose Aspirin For The Prevention Of Preterm Birth: A Prospective Study Of The Global Network For Women's And Children's Health Research, Jackie K Patterson, Simon Neuwahl, Norman Goco, Janet Moore, Shivaprasad S Goudar, Richard Derman, Matthew Hoffman, Mrityunjay Metgud, Manjunath Somannavar, Avinash Kavi, Jean Okitawutshu, Adrien Lokangaka, Antoinette Tshefu, Carl L Bose, Abigail Mwapule, Musaku Mwenechanya, Elwyn Chomba, Waldemar A Carlo, Javier Chicuy, Lester Figueroa, Nancy F Krebs, Saleem Jessani, Sarah Saleem, Robert L Goldenberg, Kunal Kurhe, Prabir Das, Archana Patel, Patricia L Hibberd, Emmah Achieng, Paul Nyongesa, Fabian Esamai, Sherri Bucher, Edward A Liechty, Brian W Bresnahan, Marion Koso-Thomas, Elizabeth M Mcclure

Department of Obstetrics and Gynecology Faculty Papers

Background: Premature birth is associated with an increased risk of mortality and morbidity, and strategies to prevent preterm birth are few in number and resource intensive. In 2020, the ASPIRIN trial showed the efficacy of low-dose aspirin (LDA) in nulliparous, singleton pregnancies for the prevention of preterm birth. We sought to investigate the cost-effectiveness of this therapy in low-income and middle-income countries.

Methods: In this post-hoc, prospective, cost-effectiveness study, we constructed a probabilistic decision tree model to compare the benefits and costs of LDA treatment compared with standard care using primary data and published results from the ASPIRIN trial. In …

Cost-Effectiveness Of Low-Dose Aspirin For The Prevention Of Preterm Birth: A Prospective Study Of The Global Network For Women’S And Children’S Health Research, Jackie K Patterson, Simon Neuwahl, Norman Goco, Janet Moore, Shivaprasad S Goudar, Richard Derman, Matthew Hoffman, Mrityunjay Metgud, Manjunath Somannavar, Avinash Kavi, Jean Okitawutshu, Adrien Lokangaka, Antoinette Tshefu, Carl L Bose, Abigail Mwapule, Musaku Mwenechanya, Elwyn Chomba, Waldemar A Carlo, Javier Chicuy, Lester Figueroa, Nancy F Krebs, Saleem Jessani, Sarah Saleem, Robert L Goldenberg, Kunal Kurhe, Prabir Das, Archana Patel, Patricia L Hibberd, Emmah Achieng, Paul Nyongesa, Fabian Esamai, Sherri Bucher, Edward A Liechty, Brian W Bresnahan, Marion Koso-Thomas, Elizabeth M Mcclure

Department of Obstetrics and Gynecology Faculty Papers

Background: Premature birth is associated with an increased risk of mortality and morbidity, and strategies to prevent preterm birth are few in number and resource intensive. In 2020, the ASPIRIN trial showed the efficacy of low-dose aspirin (LDA) in nulliparous, singleton pregnancies for the prevention of preterm birth. We sought to investigate the cost-effectiveness of this therapy in low-income and middle-income countries.

Methods: In this post-hoc, prospective, cost-effectiveness study, we constructed a probabilistic decision tree model to compare the benefits and costs of LDA treatment compared with standard care using primary data and published results from the ASPIRIN trial. In …

Pregnancy Outcome Of Women With Paroxysmal Nocturnal Hemoglobinuria, Fabrizio Zullo, Elisabetta Gragnano, Gabriele Saccone, Vincenzo Berghella, Fabrizio Pane, Maurizio Guida

Department of Obstetrics and Gynecology Faculty Papers

Objective. To evaluate maternal and perinatal outcomes in pregnant women affected by Paroxysmal Nocturnal Hemoglobinuria (PNH) treated with eculizumab with a case series and literature review.

Materials and Methods. This was a case series study with literature review. Clinical records of all consecutive pregnant women with PNH were included in the study. The systematic review was conducted using electronic databases from inception of each database through May 2021. No restrictions for language or geographic location were applied. All reports of women with PNH in pregnancy, treated with eculizumab, were included in the review. Reports of women not treated or treated …

Sperm Donor Attitudes And Experiences With Direct-To-Consumer Genetic Testing., Sascha Wodoslawsky, Joy Fatunbi, Rebecca Mercier, Andrea Mechanick Braverman

Department of Obstetrics and Gynecology Faculty Papers

OBJECTIVE: To identify factors influencing sperm donor willingness to participate in direct-to-consumer genetic testing, comfort with sharing genetically identifiable data in commercial genetic testing databases, and likelihood to donate sperm again.

DESIGN: Cross-sectional online anonymous survey.

SETTING: Multicenter, 2 large American sperm banks from July 1, 2020 to July10, 2021.

PATIENTS: Sperm donors from 1980 to 2020.

INTERVENTIONS: None.

MAIN OUTCOME MEASURES: Associations between donor demographic characteristics, donation history, and attitudes toward direct-to-consumer genetic testing.

RESULTS: A total of 396 donors completed the survey. Most donations (61.5%) occurred from 2010 to 2020, and 34.3% were nonidentified donations. Nonidentified donors were …

The Presence Of A Single Nuchal Cord In The Third Trimester May Not Affect Tei Index In Lga Fetuses, Julia Murlewska, Przemysław Poszwa, Oskar Sylwestrzak, Maria Respondek-Liberska, Dennis Wood

Department of Obstetrics and Gynecology Faculty Papers

(1) Background: The aim of this study was to assess the RV (right ventricle) and LV (left ventricle) Tei index in large for gestational age (LGA) fetuses with a single 360-degree umbilical coil of the umbilical cord around the fetal neck identified by ultrasound in the third trimester of gestation. (2) Methods: The RV and LV Tei index for the cardiac function were measured in 297 singleton pregnancies, and we identified 25 LGA fetuses. There were 48% of LGA fetuses with a nuchal umbilical cord—LGA/NC—larger for gestational age fetuses with a nuchal cord. NC was detected with a color Doppler …

Oral Ibrexafungerp For Vulvovaginal Candidiasis Treatment: An Analysis Of Vanish 303 And Vanish 306, Oluwatosin Goje, Ryan Sobel, Paul Nyirjesy, Steven R Goldstein, Mark Spitzer, Brooke Faught, Shelagh Larson, Thomas King, Nkechi E Azie, David Angulo, Jack D Sobel

Department of Obstetrics and Gynecology Faculty Papers

Background: Ibrexafungerp is a novel antifungal treatment for acute vulvovaginal candidiasis (VVC). Using pooled data from two phase three studies (VANISH 303 and 306) in the treatment of acute VVC, this analysis sought to determine the effectiveness of ibrexafungerp in various patient subgroups that may impact outcomes. Materials and Methods: Data from VANISH 303 (NCT03734991) and VANISH 306 (NCT03987620) evaluating ibrexafungerp 300 mg twice daily (BID) for 1 day versus placebo, were pooled and analyzed to determine clinical cure rate, clinical improvement, and mycological cure at the test-of-cure visit (day 11 ± 3) and symptom resolution …

Community Engagement For Birth Preparedness And Complication Readiness In The Community Level Interventions For Pre-Eclampsia (Clip) Trial In India: A Mixed-Method Evaluation, Avinash Kavi, Mai-Lei Woo Kinshella, Umesh Y Ramadurg, Umesh Charantimath, Geetanjali M Katageri, Chandrashekhar C Karadiguddi, Narayan V Honnungar, Shashidhar G Bannale, Geetanjali I Mungarwadi, Jeffrey N Bone, Marianne Vidler, Laura Magee, Ashalata Mallapur, Shivaprasad S Goudar, Mrutyunjaya Bellad, Richard Derman, Peter Von Dadelszen, The Clip India Working Group

Department of Obstetrics and Gynecology Faculty Papers

Objective: To describe the process of community engagement (CE) in northern Karnataka, India and its impact on pre-eclampsia knowledge, birth preparedness and complication readiness, pregnancy-related care seeking and maternal morbidity.

Design: This study was a secondary analysis of a cluster randomised trial of Community Level Interventions for Pre-eclampsia (CLIP). A total of 12 clusters based on primary health centre catchment areas were randomised to intervention or control. CE was conducted in intervention clusters. CE attendance was summarised according to participant group using both quantitative and qualitative assessment. Pre-eclampsia knowledge, birth preparedness, health services engagement and perinatal outcomes was evaluated within …

Clinical And Economic Evaluation Of A Proteomic Biomarker Preterm Birth Risk Predictor: Cost-Effectiveness Modeling Of Prenatal Interventions Applied To Predicted Higher-Risk Pregnancies Within A Large And Diverse Cohort, Julja Burchard, Glenn R Markenson, George R Saade, Louise C Laurent, Kent D Heyborne, Dean V Coonrod, Corina N Schoen, Jason K. Baxter, David M Haas, Sherri A Longo, Scott A Sullivan, Sarahn M Wheeler, Leonardo M Pereira, Kim A Boggess, Angela F Hawk, Amy H Crockett, Ryan Treacy, Angela C Fox, Ashoka D Polpitiya, Tracey C Fleischer, Thomas J Garite, J Jay Boniface, John A F Zupancic, Gregory C Critchfield, Paul E Kearney

Department of Obstetrics and Gynecology Faculty Papers

Objectives: Preterm birth occurs in more than 10% of U.S. births and is the leading cause of U.S. neonatal deaths, with estimated annual costs exceeding $25 billion USD. Using real-world data, we modeled the potential clinical and economic utility of a prematurity-reduction program comprising screening in a racially and ethnically diverse population with a validated proteomic biomarker risk predictor, followed by case management with or without pharmacological treatment.

Methods: The ACCORDANT microsimulation model used individual patient data from a prespecified, randomly selected sub-cohort (N = 847) of a multicenter, observational study of U.S. subjects receiving standard obstetric care with …

Using Genomic Variation To Distinguish Ovarian High-Grade Serous Carcinoma From Benign Fallopian Tubes, Jesus Gonzalez-Bosquet, Nicholas D Cardillo, Henry D Reyes, Brian J Smith, Kimberly K Leslie, David P Bender, Michael J Goodheart, Eric J Devor

Department of Obstetrics and Gynecology Faculty Papers

The preoperative diagnosis of pelvic masses has been elusive to date. Methods for characterization such as CA-125 have had limited specificity. We hypothesize that genomic variation can be used to create prediction models which accurately distinguish high grade serous ovarian cancer (HGSC) from benign tissue.

Methods: In this retrospective, pilot study, we extracted DNA and RNA from HGSC specimens and from benign fallopian tubes. Then, we performed whole exome sequencing and RNA sequencing, and identified single nucleotide variants (SNV), copy number variants (CNV) and structural variants (SV). We used these variants to create prediction models to distinguish cancer from benign …