Obstetrics and Gynecology Commons^™

Severe Maternal Morbidity According To Sickle Cell Disease Genotype, Tetsuya Kawakita, Natsume Furukawa, Sora A. Jones, Salimah Navaz Gangji

Department of Obstetrics & Gynecology Faculty Publications

Background

Sickle cell disease (SCD) is a genetic hemoglobinopathy that disproportionately affects individuals of African descent and is associated with elevated risks of maternal complications. However, the contribution of specific SCD genotypes to severe maternal morbidity (SMM) and postpartum readmission remains poorly characterized at the population level.

Objective

We sought to examine the association between SCD genotypes-hemoglobin SS (HbSS) disease, hemoglobin SC (HbSC) disease, sickle thalassemia, and sickle cell trait-and SMM, hospital readmission, and related adverse maternal outcomes.

Study design

This was a retrospective cohort study using the Nationwide Readmissions Database from 2016 through 2022, representing over 20 million weighted …

Sleepiness In Pregnancy And Adverse Perinatal Outcomes, Rachel Friedlander, Xiaoning Huang, Phyllis Zee, Sadiya S. Khan, Philip Greenland, Francesca L. Facco, Judith Chung, William A. Grobman, Shalini Manchanda, Uma M. Reddy, George R. Saade, Robert M. Silver, Lynn M. Yee

Department of Obstetrics & Gynecology Faculty Publications

Background

Sleep disorders in pregnancy have been associated with adverse pregnancy outcomes including hypertensive disorders of pregnancy, preterm birth, and gestational diabetes mellitus, yet these findings are largely from retrospective studies. Using data from a prospective study that used validated tools to assess sleepiness in pregnancy, we aimed to assess the association of sleepiness in pregnancy with adverse pregnancy outcomes.

Methods

In this secondary analysis of data from a large, diverse prospective cohort of nulliparous individuals conducted at eight United States medical centers, those with self-reported sleep data were included. Sleepiness was evaluated in early (6-13 weeks) and mid-pregnancy (22-29 …

Risk Of Gestational Diabetes By Aerobic And Resistance Exercise During The First And Second Trimesters, Takaki Tanamoto, George Saade, Leryn J. Reynolds, Tetsuya Kawakita

Department of Obstetrics & Gynecology Faculty Publications

Objective

While some studies have shown that exercise reduces the incidence of gestational diabetes mellitus (GDM), there is limited evidence on whether aerobic or resistance exercise is more beneficial. This study aimed to examine the rate of GDM according to the type of exercise during early pregnancy.

Study design

We analyzed data from the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be (nuMoM2b), a prospective cohort of individuals enrolled during the first and second trimesters. We excluded participants with pregestational diabetes or delivery < 20 weeks. The primary exposure was either aerobic or resistance exercises in the first or second trimester. For each trimester, the metabolic equivalent of task hours per week (MET-h/week) was calculated for each exercise. Participants were grouped as follows: "Aerobic exercise" (≥7.5 MET-h/week from aerobic exercises), "Resistance exercise" (≥2 times/week from resistance exercises), "Both types of exercise" (≥7.5 MET-h/week from aerobic exercise and ≥2 times/week from resistance exercises), and "Insufficient exercise" (≤7.5 MET-h/week from aerobic exercise and ≤2 times/week from resistance exercises). Our primary outcome was GDM. Adjusted relative risks (aRRs) with 95% confidence intervals (95% CIs) were calculated using modified Poisson regression, adjusting for potential confounders.

Results

In both the first and second trimesters, analyses included 9049 individuals. In the first trimester, individuals who performed …

Importance Of Placental Evaluation In Pregnancies At High Risk For Placenta Accreta Spectrum: Expert Clinical Perspective, Rebecca H. Jessel, Alesha White, Hope Y. Yu, Amie L. Hollard, Meena Khandelwal, Carolyn M. Zelop, Jennifer Philips, Alireza A. Shamshirsaz, John C. Kingdom, Alfred Abuhamad, Christina L. Herrera, Pan American Society For Placenta Accreta Spectrum (Pas2)

Department of Obstetrics & Gynecology Faculty Publications

Background

Placenta accreta spectrum (PAS) is a leading cause of obstetric morbidity and peripartum hysterectomy. Rising cesarean delivery rates, advanced maternal age, and assisted reproductive technologies have increased its incidence. Early, standardized diagnosis is essential for multidisciplinary planning and improved outcomes, yet formal screening guidelines are lacking.

Objective

To raise awareness of the importance of antenatal screening for PAS, summarize key clinical and imaging risk factors, and propose a standardized mid-trimester ultrasound protocol for high-risk patients.

Methods

An expert panel convened under the Pan-American Society for the Placenta Accreta Spectrum (PAS2) reviewed available evidence, risk stratification models, and prior consensus …

Factors Influencing Obstetric Ultrasound Examination Duration In A Tertiary Fetal Center, Juliana Gevaerd Martins, Diana Aboukhater, Tetsuya Kawakita, Maya Vishna, Salimah Navaz Gangji, Alfred Abuhamad

Department of Obstetrics & Gynecology Faculty Publications

Objective

To quantify scan duration across commonly performed obstetric ultrasound examinations in a tertiary fetal imaging center and to evaluate whether exam type, maternal body mass index (BMI), and sonographer experience independently influence scan time.

Methods

We conducted a retrospective cohort study of singleton pregnancies undergoing diagnostic obstetric ultrasound between January 2023 and May 2024 at a high-volume tertiary care center. Ultrasounds were categorized into five exam types: dating/viability (6-10 weeks), detailed first-trimester (11-14 weeks), detailed second-trimester anatomic survey (18-22 weeks), fetal echocardiography (22-24 weeks), and second/third-trimester growth/Doppler (24-38 weeks) scans. Scan duration was defined using ultrasound image timestamps from …

Longitudinal Patterns Of Urinary Biomarkers Of Placental And Renal Function In Pregnancy And Associations With Early Pregnancy Exposure To Phthalates And Replacements, Erin E. Mcnell, Danielle R. Stevens, Barrett M. Welch, Suzanne Fenton, Antonia M. Calafat, Julianne Cook Botelho, Elena Sinkovskaya, Ann Przybylska, George Saade, Alfred Abuhamad, Kelly K. Ferguson

Department of Obstetrics & Gynecology Faculty Publications

Phthalates and replacements are endocrine-disrupting chemicals that may interfere with early pregnancy processes such as placentation and renal adaptation. Placental and renal biomarkers may help examine these toxicologic mechanisms. This study aims to characterize longitudinal changes in urinary protein biomarkers of placental angiogenesis (sFlt-1, PlGF, sEng) and renal function (KIM-1, NGAL, nephrin), and investigate associations with early pregnancy exposure to phthalates and replacements. Among 291 participants from the Human Placenta and Phthalates prospective cohort, urinary metabolites of eight phthalates and two replacements were quantified at up to 2 time points from 12 to 15 weeks gestation. Repeated measures were averaged …

The Taper Sign: Sonographic Representation Of Uterine Dehiscence In Severe Cases Of Placenta Accreta Spectrum, Uma Deshmukh, Anna M. Modest, Alfred Abuhamad, Alireza A. Shamshirsaz, Jonathan L. Hecht, Scott A. Shainker

Department of Obstetrics & Gynecology Faculty Publications

Introduction: Prenatal diagnosis of placenta accreta spectrum (PAS) depends on reliable ultrasound markers and skilled image interpretation. Existing PAS markers emphasize placental features suggestive of abnormal adherence and require advanced image optimization. However, emerging hypotheses suggest that uterine dehiscence—not placental invasion—is the central mechanism underlying PAS, particularly in severe (Grade 3) disease. Despite this, few established ultrasound markers address this uterine dehiscence. We describe a novel ultrasound marker, the taper sign, which uniquely represents the uterine dehiscence in severe PAS with anterior placenta previa, and outline a standardized technique for image acquisition and interpretation.

Methods: This descriptive report details the …

Hungarian Validation Of The Pelvic Floor Distress Inventory - 20 (Pfdi-20) Questionnaire And The Pelvic Floor Impact Questionnaire - 7 (Pfiq - 7), Barbara Kozma, Bence Kozma, Peter Takacs, Dávid Rátonyi, Nelli Farkas, Attila G. Sipos, Balint Farkas

Department of Obstetrics & Gynecology Faculty Publications

Introduction and Hypotheses

Pelvic floor disorders (PFDs) affect women's quality of life through physical, psychological, and social domains. The Pelvic Floor Distress Inventory-20 (PFDI-20) and the Pelvic Floor Impact Questionnaire-7 (PFIQ-7) are validated tools for assessing symptom severity and quality of life impact. The current study aim to investigate the reliability and validity of the Hungarian versions of these questionnaires in women with PFD symptoms.

Methods

This validation study was carried out at the University of Debrecen among women with clinically confirmed pelvic floor disorders. The PFDI-20 and PFIQ-7 questionnaires were translated into Hungarian using independent native English speaker in …

The Impact Of The 7th October War On Preterm Birth Rates And Neonatal Outcomes: A Retrospective Comparative Study From Northern Israel, Raghda Zidan Sweid, Adi Sharabi Nov, Hana Helfgot, Steven L. Warsof, Inbar Ben-Shachar

Department of Obstetrics & Gynecology Faculty Publications

PURPOSE: Maternal psychological stress is associated with adverse obstetric and neonatal outcomes, including preterm birth and low birthweight. Warfare represents a significant source of acute and chronic stress, yet its impact on pregnancy outcomes remains unclear. This study aimed to evaluate the association between a 6-month period of continuous wartime exposure following October 7, 2023, during the "Iron Swords" conflict and preterm birth, neonatal outcomes, and obstetric management.

METHODS: This retrospective cohort study included all deliveries at ZIV Medical Center during the 6-month conflict period, compared with a pre-war cohort from 2021 until October 6, 2023. The primary outcome was …

Racial Differences In Adverse Pregnancy Outcomes And Incident Hypertension: A Mediation Analysis, Lucia C. Petito, Xiaoning Huang, C. Noel Bairey, Natalie Bello, Janet Catov, Ernesto Licon, Abbi Lane, David M. Haas, Lisa D. Levine, Rebecca B. Mcneil, Eliza Miller, Uma M. Reddy, Bethany Barone Gibbs, George Saade, Lauren Theilen, Laura E. Wiener, Brian M. Mercer, Hyagriv N. Simhan, Lynn M. Yee, Philip Greenland, William A. Grobman, Sadiya S. Khan

Department of Obstetrics & Gynecology Faculty Publications

Background

Adverse pregnancy outcomes (APOs) are associated with increased hypertension risk. Black women experience higher rates of APOs and hypertension compared with White women, but whether APOs contribute to Black-White hypertension disparities remains unknown.

Methods

The nuMoM2b-HHS (Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-To-Be-Heart Health Study) prospectively recruited nulliparous pregnant people at 8 US centers (2010-2013) with follow-up 2 to 7 years postpartum (2014-2017). Race, which represents a social construct, was self-identified. The primary outcome was incident hypertension at follow-up. APOs included hypertensive disorders of pregnancy, preterm birth, and small-for-gestational age birth. Potential confounders (psychological health, social factors, and health behaviors) …

Vaginal Pra1 Identifies Clinically Relevant Candida Albicans Vaginitis And Excludes Asymptomatic Colonization: An Exploratory Study, Elena Roselletti, Barbara Kozma, David Ratonyi, Alexandra Kunkli, Bence Kozma, Peter Takacs, Duncan Wilson

Department of Obstetrics & Gynecology Faculty Publications

Background

Accurate interpretation of Candida detection in women with vulvovaginal symptoms remains difficult, because organism recovery may reflect either clinically relevant infection or nonpathogenic colonization. We have recently demonstrated that the secreted fungal zinc-binding protein, Pra1 is responsible for driving the inflammatory immunopathology of VVC. We therefore reasoned that PRA1 expression by Candida albicans in the vagina may act as a diagnostic tool to discriminate between commensal colonisation and active disease.

Methods

We conducted a 12-week prospective, single-center exploratory biomarker analysis nested within a registered parent clinical trial. Nine women with vulvovaginal symptoms provided cervicovaginal lavage samples and clinical data …

Considerations For The Analysis Of Urinary Environmental Chemical Concentrations During Pregnancy, Danielle R. Stevens, Kaleigh Hinton, Katie M. O'Brien, Jessie P. Buckley, Barrett M. Welch, Jason A. Watts, Antonia M. Calafat, Julianne C. Botelho, Elena Sinkovskaya, Ann Przybylska, George Saade, Alfred Abuhamad, Kelly K. Ferguson

Department of Obstetrics & Gynecology Faculty Publications

Background:

Pregnancy physiology may impact indicators of hydration, affecting exposure assessment in gestational studies with urinary chemical biomarkers.

Methods:

We aimed to characterize hydration and demonstrate the impact of different methods for standardizing urinary chemical biomarker concentrations on exposure descriptives in the Human Placenta and Phthalates Study (n = 303, 2017-2020), a prospective pregnancy cohort with eight study visits between 12 and 38 weeks of gestation. We assessed trajectories and predictors of hydration using urine flow rate (UFR) and specific gravity (SG). Likewise, we examined trajectories and predictors of mono-n-butyl phthalate (MBP), for which concentrations were unstandardized or standardized via …

Osmotic Dilators Vs. Foley Balloons: Bayesian Secondary Analyses Of The Dilafol Trial, Antonio F. Saad, Elenir B. C. Avritscher, Claudia Pedroza, Xiao Han, George R. Saade

Department of Obstetrics & Gynecology Faculty Publications

Background: Dilapan-S, a synthetic osmotic dilator used for pre-induction cervical ripening, has proven to be as effective as the Foley balloon in terms of vaginal versus cesarean delivery and has been associated with increased patient satisfaction. Nevertheless, its ability to lower cesarean rates and its cost-effectiveness remain poorly studied.

Objectives: To estimate the likelihood that synthetic osmotic dilators reduce cesarean deliveries and to evaluate their health system costs (2026 US$) and incremental cost-effectiveness compared to the Foley balloon during cervical ripening.

Study Design: Secondary Bayesian analyses were conducted using data from the single-center DILAFOL randomized controlled trial, which enrolled 419 …

Adjunctive Technologies To Electronic Fetal Monitoring: Promise, Pitfalls, And Lessons Learned, Rebecca Horgan, George Saade

Department of Obstetrics & Gynecology Faculty Publications

Despite widespread use, electronic fetal monitoring (EFM) has not demonstrably reduced perinatal morbidity or mortality, and likely contributed to the rise in cesarean delivery. To improve its utility, a number of adjunctive approaches have been introduced over the past three decades, including fetal pulse oximetry, ST segment analysis (STAN), and maternal oxygen supplementation. Each intervention was supported by strong physiologic rationale, yet none achieved widespread clinical adoption due to inconsistent evidence of benefit and, in some cases, potential harm. This review critically evaluates landmark studies on EFM adjuncts, highlights the limitations that have impeded progress, and outlines emerging innovations, including …

Acute Fatty Liver Of Pregnancy And Fetal Fatty Acid Oxidation Disorders: A Systematic Review, Dante Varotsis, Sarah Araji, Rebecca Horgan, Jennifer E. Powel, Rodney Mclaren Jr., Brian Kirmse, Mona Makhamreh, Huda B. Al-Kouatly

Department of Obstetrics & Gynecology Faculty Publications

OBJECTIVE:

To evaluate the association between maternal acute fatty liver of pregnancy (AFLP) and fetal fatty acid oxidation (FAO) disorders and to define the clinical and genetic characteristics of mothers with AFLP and their fetuses affected by FAO disorders, we performed a systematic literature review of all reported cases of AFLP that underwent genetic testing for FAO disorders.

DATA SOURCES:

We searched PubMed, Ovid MEDLINE, Cochrane Library, CINAHL (EBSCO), Scopus, and ClinicalTrials.gov. Terms included were related to AFLP and FAO testing.

METHODS OF STUDY SELECTION:

We conducted a systematic literature review from inception through May 18, 2025, to evaluate the …

The Association Between Social Vulnerability And Racial Disparities In Preterm Birth, Anita Pershad, Gabby Adams, Lindsay Robbins, George Saade, Tetsuya Kawakita

Department of Obstetrics & Gynecology Faculty Publications

Objective

To evaluate the association between county-level social vulnerability and preterm birth and assess whether racial disparities vary across levels of vulnerability.

Methods

This cross-sectional study utilized restricted Centers for Disease Control and Prevention natality data from 2023. We included Black or White births with singleton pregnancies across 3123 US counties from 50 US states and the District of Columbia. Participants were grouped into quartiles based on the county-level Social Vulnerability Index (SVI), with quartile 4 representing the most socially vulnerable populations. The primary outcome was preterm birth, defined as delivery before 37 weeks. Secondary outcomes included small for gestational …

The Association Between Maternal-Fetal Medicine Physician Density And Pregnancy Outcomes, Tetsuya Kawakita, Rula Atwani, Misa Hayasaka, Lindsay Robbins, George Saade

Department of Obstetrics & Gynecology Faculty Publications

Objective

We sought to examine the association between maternal-fetal medicine (MFM) physician density and adverse pregnancy outcomes at the state level.

Study Design

This was a cross-sectional analysis of publicly available, state-level data from 2018 to 2021, including Natality, Multiple Cause-of-Death, and Fetal Death databases. The number of active MFM physicians per year was obtained for each state from the American Medical Association Masterfile. The primary exposure was the density of MFM per state, categorized into three groups: (1) low density (< 30 MFM physicians per 100,000 live births), (2) moderate density (30-59 MFM physicians per 100,000 live births), and (3) high density (≥60 MFM physicians per 100,000 live births). Our primary outcome was maternal mortality during pregnancy and up to 42 days postdelivery. Our secondary outcomes were pregnancy-related mortality up to 365 days postdelivery and stillbirth. We calculated adjusted incident rate ratios (aIRR) and average marginal effect (AME) with 95% confidence intervals (95% CI) using multivariable negative binomial mixed effects regression models.

Results

Overall, there were 14,792,743 live births, 3,440 maternal mortalities, 4,980 pregnancy-related mortalities, and 90,848 stillbirths included. The …

Mediating Effect Of Social Determinants Of Health Between Race And Phthalate Biomarkers In Pregnancy, Tetsuya Kawakita, Misa Hayasaka, Carole Barake, Trinity Soto, Jillian Fleming, Amir Lueth, Stevens Danielle, Alfred Abuhamad, Ann Pryzybylska, Elena Sinkovskaya, Kelly K. Ferguson, George Saade

Department of Obstetrics & Gynecology Faculty Publications

Introduction

Prenatal phthalate exposure is linked to adverse reproductive and developmental outcomes and is consistently higher among non‐Hispanic Black compared to non‐Hispanic White pregnant individuals, yet the factors responsible for these disparities are poorly characterized. We sought to quantify Black–White differences in repeated urinary concentrations of phthalate biomarkers during pregnancy and to estimate the extent to which neighborhood‐level social determinants of health (SDoH) mediate these disparities.

Methods

This secondary analysis used data from the Human Placenta Project Study, a prospective observational cohort study conducted at two academic institutions between 2016 and 2018. Eligible participants had singleton pregnancies, were recruited before …

Contribution Of Comorbidities And Pregnancy Complications To Severe Maternal Morbidity In The United States, Tetsuya Kawakita, Sora A. Jones, Natsume Furukawa, George Saade

Department of Obstetrics & Gynecology Faculty Publications

Objective: To quantify the extent to which rising rates of severe maternal morbidity (SMM) in the United States from 2016 to 2022 are attributable to increasing prevalence of maternal risk factors, including advanced maternal age, obesity, pregestational diabetes mellitus, gestational diabetes, chronic hypertension, and hypertensive disorders of pregnancy (HDP).

Methods: We conducted a retrospective cohort study using the Nationwide Readmissions Database from 2016 to 2022, representing more than 25 million weighted delivery hospitalizations. The primary outcome of SMM was identified with the Centers for Disease Control and Prevention's 21-condition algorithm; a secondary outcome excluded transfusion to improve specificity. Temporal trends …

Cervicovaginal Lavage Fluid Iron And Manganese Levels In Women With And Without Vaginitis, Barbara Kozma, David Ratonyi, Bence Kozma, Peter Takacs, Attila G. Sipos

Department of Obstetrics & Gynecology Faculty Publications

Transition metals such as iron and manganese are critical for cellular metabolism, redox balance, and immune function, and they also influence host–pathogen interactions. Vaginitis is characterized by mucosal inflammation that may alter local trace-element homeostasis. We hypothesize that inflammatory conditions such as vaginitis may be associated with altered cervicovaginal iron and manganese levels. We performed a prospective, single-center cohort study at the University of Debrecen (Hungary) between April 2023 and April 2024, enrolling 80 women ≥ 18 years with vulvovaginal complaints. Participants were assessed at baseline and at weeks 4, 8, and 12 with clinical evaluation and cervicovaginal lavage (CVL) …

Estetrol (E4) For The Treatment Of Moderate To Severe Vasomotor Symptoms In Postmenopausal Women - Efficacy And Safety Results From The Phase 3 E4comfort I Multicenter, Placebo-Controlled Study, Tommaso Simoncini, Céline Bouchard, Marie Cloes, Mélanie Taziaux, Santiago Palacios, Sebastião Freitas De Medeiros, Valeriu Vrabii, David F. Archer, Nick Panay

Department of Obstetrics & Gynecology Faculty Publications

Objective

To evaluate the efficacy and safety of estetrol in reducing moderate to severe vasomotor symptoms in postmenopausal women.

Methods

Multicenter, randomized, parallel group (1:1:1), placebo-controlled, double-blind, phase 3 study in hysterectomized and non-hysterectomized participants aged 40-65 years. A total of 640 participants with seven or more moderate to severe hot flashes daily or 50 weekly received estetrol 15 mg, estetrol 20 mg, or placebo for 12 weeks. Co-primary endpoints were the change in frequency and severity of moderate to severe vasomotor symptoms from baseline to weeks 4 and 12. Comparisons versus placebo were made using a mixed-effects model for …

Evaluating The Mediating Role Of Gestational Phthalate And Replacement Biomarkers In The Associations Between Race/Ethnicity And Birthweight, Amir J. Lueth, Danielle R. Stevens, Sarahna A. Moyd, Elena Sinkovskaya, Ann Przybylska, Antonia M. Calafat, Julianne C. Botelho, George Saade, Alfred Abuhamad, Kelly K. Ferguson

Department of Obstetrics & Gynecology Faculty Publications

Background

Gestational exposure to phthalates is higher among non-Hispanic black (NHB) women than non-Hispanic white (NHW) women and may contribute to racial/ethnic differences in birthweight z-scores.

Objective

We aimed to investigate whether gestational phthalate and replacement biomarkers mediate the association between race/ethnicity and birthweight z-scores.

Methods

We analyzed data from 271 pregnancies in the Human Placenta and Phthalates study, a prospective cohort recruited from 2017 to 2020. Urinary phthalate metabolite concentrations were measured at up to eight time points during pregnancy and averaged to represent gestational exposure. Metabolites were grouped by parent compound. Linear regression models estimated associations in phthalate …

Methodological And Clinical Concerns In The Study On Postpartum Hypertension Management, Takaki Tanamoto, Kyosuke Kamijo, Yusuke Tsutsumi, Tetsuya Kawakita

Department of Obstetrics & Gynecology Faculty Publications

[Introduction] We read with interest the recent study by Rosenfeld et al.¹ However, we have several clinical and methodological concerns about this study.¹

First, this study's propensity score matching (PSM) lacked key clinical confounders, including perinatal risk factors and the highest systolic/diastolic blood pressures. Smoking, alcohol use, and multifetal gestation, which influence blood pressure during pregnancy,²,³ potentially affect both primary and secondary outcomes. Additionally, the authors did not report standardized mean differences before and after PSM, which are essential for assessing balance.⁴

Diagnosis Of Hypertensive Disorders In Pregnancy, Rebecca Horgan, Yara Hage Diab, Maged Costantine, George Saade, Baha Sibai

Department of Obstetrics & Gynecology Faculty Publications

Hypertensive disorders of pregnancy, including chronic hypertension, superimposed preeclampsia, gestational hypertension, and preeclampsia, affect 10-20% of pregnancies and are a significant cause of maternal and perinatal mortality. The incidence of these disorders is rising due to factors such as advanced maternal age, obesity, assisted reproductive technology, and increased rates of preexisting comorbidities. Differentiating pregnancy-associated hypertension from pre-existing chronic hypertension is challenging, as the overlap between the two may be broadening due to the changing demographics of the pregnant population. This review critically evaluated the evidence regarding the current time periods recommended to make a diagnosis of a hypertensive disorder of …

Formulation Development Of Dual-Compartment Topical Inserts Combining Tenofovir Alafenamide And Elvitegravir For Flexible On-Demand Hiv Prevention, Vivek Agrahari, M. Melissa Peet, Neelima Chandra, Prakash Ramalingam, Pardeep K. Gupta, Sriramakamal Jonnalagadda, Onkar N. Singh, Timothy J. Mccormick, Gustavo F. Doncel, Meredith R. Clark

Department of Obstetrics & Gynecology Faculty Publications

Pre-exposure prophylaxis (PrEP) has emerged as a prominent approach for the prevention of HIV infections. While the latest advances have resulted in effective oral and injectable product options, there are still gaps in on-demand, event-driven, topical products for HIV prevention that are safe and effective. Here we describe the formulation development of a dual-compartment topical insert containing tenofovir alafenamide fumarate (TAF) and elvitegravir (EVG) that may be administered when needed, vaginally or rectally, pre- or post-coitus, for flexible HIV prophylaxis. Specifically, we describe the lab-scale formulation development, preclinical mucosal safety and pharmacokinetics (PK) testing in rabbits, long-term stability, and scale-up …

Exposure To Phthalates And Replacements During Pregnancy In Association With Gestational Blood Pressure And Hypertensive Disorders Of Pregnancy, Erin E. Mcnell, Danielle R. Stevens, Barrett M. Welch, Emma M. Rosenthal, Suzanne Fenton, Antonia M. Calafat, Julianne Cook Botelho, Elena Sinkovskaya, Ann Przybylska, George Saade, Alfred Abuhamad, Kelly K. Ferguson

Department of Obstetrics & Gynecology Faculty Publications

Exposure to endocrine-disrupting chemicals such as phthalates may increase risk of hypertensive disorders of pregnancy (HDP). Prior studies lack investigation of chemical mixtures, phthalate replacements, or key periods of susceptibility including early pregnancy. In the present study, we used a longitudinal approach to evaluate gestational exposure to phthalates and replacements, as both single-pollutants and mixtures, in association with blood pressure and diagnosis of preeclampsia or any HDP. The Human Placenta and Phthalates prospective pregnancy cohort includes 291 participants recruited from two U.S. clinics. Urinary metabolites of ten phthalates and replacements were quantified at up to 8 time points per individual …

Association Between Adverse Pregnancy Outcomes And Awareness Of Cardiovascular Risk Factors: A Numom2b-Hhs Secondary Analysis, Elizabeth M. Wendl, Amanda A. Allshouse, Ashley Goodwin, Bri Hobbs, Philip Greenland, Lisa Levine, William Grobman, George R. Saade, Natalie Cameron, C. Noel Bairey Merz, Caroline Rouse, Sarah Rogan, Judith H. Chung, Lauren H. Theilen, National Heart, Lung, And Blood Institute Numom2b Heart Health Study Network

Department of Obstetrics & Gynecology Faculty Publications

Background

Adverse pregnancy outcomes (APOs) affect 10%-20% of pregnancies and are associated with increased risk of cardiovascular disease.

Objective

To determine whether the history of APO is associated with a person's awareness of their cardiovascular risk factors (CRF) 2-7 years postpartum.

Methods

This is a secondary analysis of a multicenter cohort study in which nulliparous pregnant people were enrolled in the first trimester and followed prospectively. Participants with a CRF (hypertension, dyslipidemia, and/or prediabetes/diabetes) at follow-up were included. We excluded participants with: pre-gestational diabetes, chronic hypertension, dyslipidemia during the index pregnancy or subsequent pregnancy, and non-fasting blood draws. The exposure …

3d Bioprinting Technology Innovation In Female Reproductive System, Siyao Chen, Tongxin Wang, Jiaqi Chen, Mingxing Sui, Luyao Wang, Xueyu Zhao, Jianqiao Sun, Yingli Lu

Department of Obstetrics & Gynecology Faculty Publications

Several diseases affect the female reproductive system, and both disease factors and treatments impact its integrity and function. Consequently, understanding the mechanisms of disease occurrence and exploring treatment methods are key research focuses in obstetrics and gynecology. However, constructing accurate disease models requires a microenvironment closely resembling the human body, and current animal models and 2D in vitro cell models fall short in this regard. Thus, innovative in vitro female reproductive system models are urgently needed. Additionally, female reproductive system diseases often cause tissue loss, yet effective tissue repair and regeneration have long been a bottleneck in the medical field. …

Association Between The Social Vulnerability Index And Adverse Pregnancy Outcomes, Tetsuya Kawakita, Misa Hayasaka, Lindsay Robbins, Juliana Martins, George Saade

Department of Obstetrics & Gynecology Faculty Publications

Objective: To assess the association between the Social Vulnerability Index (SVI) and racial disparities in pregnancy outcomes across U.S. counties and to quantify these racial disparities.

Methods: This was a cross-sectional study using restricted Centers for Disease Control and Prevention data sets, including natality data sets, fetal death data sets, and all-cause mortality data sets from 2016 to 2021. We limited analyses to Black or White individuals aged 15-44 years from 3,114 U.S. counties. Participants were categorized into quartiles based on county-level SVI. The primary outcome was maternal mortality rate while pregnant or within 42 days of the end of …

Longitudinal Assessment Of Intravillous Arterioles In Normal Pregnancy Using Superb Microvascular Imaging, R. Horgan, E. Sinkovskaya, G. Saade, E. Kalafat, A. Heeze, A. Abuhamad

Department of Obstetrics & Gynecology Faculty Publications

Objective

To use superb microvascular imaging (SMI) to longitudinally evaluate blood flow in intravillous arterioles (IVA) in pregnancy, and to develop reference ranges for IVA pulsatility index (PI) and peak systolic velocity (PSV) from 12 to 38 weeks' gestation.

Methods

The data for this study were obtained from the National Institutes of Health-funded Human Placenta Project. Eligible for inclusion were women aged 18-35 years, with a body mass index of <  30 kg/m², without comorbidities, with a singleton pregnancy conceived spontaneously and a gestational age of ≤ 13 + 6 weeks. Exclusion criteria were maternal or neonatal complications, fetal or umbilical cord anomalies, abnormal placental implantation and delivery <  37 weeks. Each participant underwent eight ultrasound examinations during pregnancy. Using SMI technology, the total number of IVA identified was recorded in a sagittal placental section at the level of cord insertion. The PI and PSV were measured in a total of six IVA (two in the central portion of the placenta, two peripherally towards the uterine fundal portion and two peripherally towards the lower uterine segment). Umbilical artery (UA)-PI was also obtained. Multilevel regression models were used to create reference ranges for IVA-PI and IVA-PSV at 12-38 weeks' gestation.

Results

A total of 90 women fulfilled the study criteria. IVA-PI decreased throughout pregnancy from a mean ± SD of 1.04 ± 0.23 in the first trimester (at 12-13 weeks) …