Obstetrics and Gynecology Commons^™

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 …

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 …

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 …

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 …

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 …

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 …

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 …

Prepregnancy Diet Quality Index And Adverse Pregnancy Outcomes, Ummayhany Bharmal, George Saade, Philip Greenland, Brenda J. Smith, Andrea C. Kozai, Stephanie A. Fisher, Lauren Theilen, William Grobman, Noel Bairey Merz, Uma Reddy, Tetsuya Kawakita

Department of Obstetrics & Gynecology Faculty Publications

Introduction

Adverse pregnancy outcomes (APOs) are a major cause of maternal and neonatal morbidity.¹ Preconception diet quality is associated with APO risk,² but prior pregnancy-related indices had notable limitations.³ We developed the Prepregnancy Dietary Quality Index (PreP-DQI) to assess its association with APOs and cardiometabolic health.

Methods

This cohort study used data from the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-Be (NuMoM2b) and the NuMoM2b-Heart Health Study (NuMoM2b-HHS),⁴,⁵ excluding individuals who delivered before 23 weeks of gestation, had fetal anomalies, missing dietary data, or had implausible caloric intake (below 1st percentile or above 99th percentile). All participants in the original studies …

Low-Lying Placenta Is Associated With Increased Risk Of Hemorrhage And Severe Maternal Morbidity: A Nationwide Analysis, May Abiad, Giulia Bonanni, Nikan Zargarzadeh, Ali Javinani, Scott A. Shainker, Anna M. Modest, George R. Saade, Kjersti Aagaard, Alireza A. Shamshirsaz

Department of Obstetrics & Gynecology Faculty Publications

Background

Placenta previa (PP) is a well-recognized obstetric complication with established maternal risks, particularly hemorrhage, that contribute significantly to maternal morbidity. In contrast, low-lying placenta (LLP) has historically been grouped with previa in both coding and clinical practice, limiting our ability to study its imparted associated outcomes as a distinct entity. However, in 2017, coding revisions allowed for a parsed diagnosis of LLP and PP and enabled the current study of differentiated associated outcomes.

Objectives

To describe and compare the independent rates of hemorrhage and severe maternal morbidity (SMM) associated with LLP and PP relative to normal placentation.

Methods

We …

Assessing The Impact Of Maternal Oral Health On The Risk Of Adverse Birth Outcomes, May Amr Salama

Health Services Research Dissertations

Preterm birth (PTB) and low birth weight (LBW) are leading causes of neonatal morbidity and mortality. Maternal periodontal disease (PD) has been increasingly linked to these adverse birth outcomes (ABOs), yet questions about causality and treatment effectiveness persist due to study design heterogeneity and potential unmeasured confounding. These gaps hinder the development of clear clinical and public health guidelines. This dissertation addresses these gaps through three interconnected studies assessing the relationship between maternal oral health and ABOs.

The first study employed a meta-epidemiological analysis of 62 original studies from nine systematic reviews to evaluate the impact of unmeasured confounding on …

Socioeconomic, Behavioral, And Health Profiles Of Women With Eclampsia: Findings From The 2020–2022 National Pregnancy Risk Assessment Monitoring System Data, Jessi Bates, Gurgen Grigoryants, Hongyun Fu

Cardiovascular Research Symposium

Background: Eclampsia is a severe obstetric complication with significant maternal health implications, disproportionately affects women with certain sociodemographic and health risk factors. This study investigates the characteristics and outcomes of women who experienced eclampsia using data from the national Pregnancy Risk Assessment Monitoring System (PRAMS).

Methods: This analysis included a sample of 729 women with eclampsia from the 2020–2022 PRAMS (N = 238,575). Descriptive statistics, chi-square tests, and multivariate logistic regression were conducted to examine patterns and factors associated with preterm-birth, low birth weight (LBW), and cesarean delivery.

Results: Over half of the women were aged ≥35 years (50.6%), unmarried …

Neonatal Outcomes In Periviable Births Weighing ≤ 500 Grams, Bijan Morshedi, Diego Maurente, Ursula Griffiths-Randolph, Elisabeth Kamano, Katharine Hopkins, Dana Baraki, Juliana Martins, Steven Warsof

Eastern Virginia Medical Journal

Background: The average rate of preterm birth in the US in 2021 was 10.1%. Although the rate of mortality from preterm birth has been decreasing, complications remain the leading cause of death in infants under the age of 5 years worldwide. Gestational age (GA) and birth weight (BW) remain the 2 most important variables for predicting survivability in preterm births, and lower GA and BW are both correlated with lower survivability.

Objective: To explore outcomes of neonates born in the periviable period (20 weeks and 0 days to 25 weeks and 6 days) with BW ≤ 500 g and to …

Interobserver Variability Regarding Adequacy Of Oropharyngeal Exposure For Transoral Robotic Surgery May Necessitate Staging Endoscopy: Evaluating Tors Exposure, Colleen Schinderle, Kevin J. Carlson, Reem Sharaf Alddin, Jeffery J. Houlton, Matthew J. Bak, Daniel W. Karakla, Jonathan R. Mark

Department of Otolaryngology (ENT) Faculty Publications

[First paragraph] Transoral robotic surgery (TORS) for the treatment of oropharyngeal cancer has become centered at tertiary referral centers. To avoid treatment delays or multiple anesthetics, the need for repeat operative endoscopy may be questioned when the diagnosis has been made at an outside institution. However, inadequate visualization of relevant anatomy can preclude TORS candidacy and may lead to procedure abortion or conversion to an open technique.²,³ To evaluate this dilemma, we explored the ability to assess oropharyngeal exposure for TORS candidacy via operative endoscopic photo-documentation.

Inflammatory Mediators And The Rage Pathway In Placental Tissues Of Pregnancies Complicated By Severe Preeclampsia, Neelima Chandra, Thomas D. Kimble, Kathleen R. Heim, Sharon M. Anderson, Andrew P. Wong, Andrea R. Thurman, Gustavo F. Doncel

CONRAD Publications

Introduction: Preeclampsia (PE) is a complex multisystem disorder of pregnancy associated with abnormal placentation, vascular anomalies, and systemic inflammation and hypertension. Previous research assessing inflammatory triggers of the condition used plasma, amniotic fluid, or explant samples. Studies using placental tissue from either vaginal or cesarean deliveries are confined to semiquantitative analysis using subjective scoring methods and generally involve a small sample size.

Methods: In this study, we have quantified the expression of inflammatory mediators by immunohistochemical image analysis of archived placental tissues obtained from cesarean delivery of preeclamptic, chorioamnionitic, and normal pregnancies.

Results: Among the inflammatory mediators, we found a …

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 …

Association Of Maternity Care Deserts With Maternal And Pregnancy-Related Mortality, Rula Atwani, Lindsay Robbins, George Saade

Department of Obstetrics & Gynecology Faculty Publications

OBJECTIVE:

To evaluate the association between the level of maternity care access and maternal and pregnancy-related mortality.

METHODS:

This was a cross-sectional analysis of county-level data in the United States from January 2018 to December 2021. Using the level of maternity care access, we categorized counties into desert, low access, moderate access, and full access. The primary outcome of interest was maternal mortality rate per 100,000 live births. A secondary outcome was pregnancy-related mortality rate per 100,000 live births. Absolute risk differences and adjusted incidence rate ratios were calculated for maternal mortality and pregnancy-related mortality with multivariable negative binomial mixed-effects …

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) …

Timing Of Delivery In Preeclampsia: Time To Reconsider?, Rebecca Horgan, Ahmed S. Z. Moustafa, Mackenzie Mchugh, Tetsuya Kawakita, Baha Sibai, George Saade

Department of Obstetrics & Gynecology Faculty Publications

The article discusses the need to reassess the timing of delivery in cases of preeclampsia, a condition affecting 2%–8% of pregnancies and linked to significant maternal and neonatal risks. It highlights that existing guidelines, primarily based on older studies, may not adequately reflect current clinical practices and advancements in neonatal care. The authors suggest that planned delivery at 34–36 weeks of gestation may offer maternal benefits without increasing short-term neonatal morbidity, while also emphasizing the importance of considering long-term outcomes for both mothers and infants. They advocate for further research, including large-scale randomized trials, to better understand the implications of …

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 …

Effectiveness And Safety Of Intravenous Iron Therapy In Outpatient Obstetrical Clinic For Treatment Of Iron-Deficiency Anemia During Pregnancy, Ellen M. Murrin, Olivia S. Lebeau, Lillian Singer, Mark A. Kassab, Peyton Kalan, Julie Costanzo, Scott A. Sullivan, George L. Maxwell, George R. Saade, Antonio F. Saad

Department of Obstetrics & Gynecology Faculty Publications

Background

Iron-deficiency anemia (IDA) affects over one-third of pregnant patients globally, contributing to severe maternal morbidity and adverse neonatal outcomes. Oral iron supplementation, while cost-effective, is limited by poor absorption, significant gastrointestinal side effects, and poor adherence. The use of intravenous (IV) iron addresses many of these concerns, including eliminating GI side effects and the need for daily therapy. However, administration of IV iron in pregnant patients is typically restricted to specialized infusion centers or hospitals due to concerns about acute side effects, cost, resource utilization, the need for fetal heart rate monitoring, and extended infusion times.

Methods

This descriptive …

Impacts Of Ramadan Fasting During Pregnancy On Pregnancy And Birth Outcomes: An Umbrella Review, Abdullah Al-Taiar, Md Estiar Rahman, May Salama, Ali H. Ziyab, Wilfried Karmaus

Epidemiology, Biostatistics, & Environmental Health Faculty Publications

Background

Despite a large number of primary research studies, and systematic and narrative reviews, there is no consensus on the impact of fasting during Ramadan while pregnant on pregnancy and birth outcomes. Currently, there is no evidence-based guideline for Muslim women regarding Ramadan fasting during pregnancy and clinicians cannot provide firm recommendations.

Objectives

To review the current evidence regarding the impact of Ramadan fasting during pregnancy on pregnancy and birth outcomes.

Search Strategy

We conducted an umbrella review of all systematic and narrative reviews examining the impacts of fasting during Ramadan while pregnant on pregnancy and birth outcomes by searching …

The Role Of Doulas In The Health Care Continuum For Pregnant People With Substance Use Disorder: Perspectives Of Patients, Doulas, And Healthcare Providers, Dashaunda Taylor, Derek A. Chapman, Caitlin E. Martin, Cynthia C. F. Romero, Gerard Moeller

Epidemiology, Biostatistics, & Environmental Health Faculty Publications

Objectives/Goals: The goals of this research are to 1) determine the prevalence of perinatal doula services use in Virginia, with a focus on individuals with substance use disorders (SUD), 2) evaluate awareness of doulas among pregnant and postpartum people with SUD, and 3) assess provider knowledge and interaction with doulas for the care of this population. Methods/Study Population: Both quantitative and qualitative methods will be used to evaluate patient and healthcare provider knowledge regarding doula services and the patient–doula–healthcare provider relationship. Surveys and semi-structured interviews will be administered to doulas, pregnant and postpartum women, and healthcare providers in this mixed-methods …

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 …

Association Of Prenatal Exposure To Phthalates And Phenols With Adverse Pregnancy Outcomes, Misa Hayasaka, Diana Aboukhater, George Saade, Tetsuya Kawakita

Department of Obstetrics & Gynecology Faculty Publications

OBJECTIVE:

To evaluate the association between prenatal exposures to phthalates and phenols and adverse pregnancy outcomes, including preterm birth (PTB), small-for-gestational-age (SGA) birth weight, and gestational diabetes mellitus (GDM).

METHODS:

This study analyzed data from the Environmental Influences on Child Health Outcomes consortium, which harmonized longitudinal data on more than 30,000 pregnancies and 57,000 children from 69 cohorts across the United States and Puerto Rico. Pregnancy outcomes included PTB, SGA, and GDM, identified from medical records or self-reports. Generalized estimating equations models with Poisson distribution and robust variance were used to estimate relative risks (RRs) and 95% CIs per interquartile …

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

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 …

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 …