Medicine and Health Sciences Commons^™

Clinical Presentation Of Coronavirus Disease 2019 (Covid-19) In Pregnant And Recently Pregnant People., Yalda Afshar, Stephanie L Gaw, Valerie J Flaherman, Brittany D Chambers, Deborah Krakow, Vincenzo Berghella, Alireza A Shamshirsaz, Adeline A Boatin, Grace Aldrovandi, Andrea Greiner, Laura Riley, W John Boscardin, Denise J Jamieson, Vanessa L Jacoby

Department of Obstetrics and Gynecology Faculty Papers

OBJECTIVE: To describe the clinical presentation, symptomology, and disease course of coronavirus disease 2019 (COVID-19) in pregnancy.

METHODS: The PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY) study is an ongoing nationwide prospective cohort study of people in the United States who are pregnant or up to 6 weeks postpregnancy with known or suspected severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. We analyzed the clinical presentation and disease course of COVID-19 in participants who tested positive for SARS-CoV-2 infection and reported symptoms at the time of testing.

RESULTS: Of 991 participants enrolled from March 22, 2020, until July 10, 2020, 736 had …

Do Not Forget Our Pregnant Women During The Covid-19 Pandemic, Gabriel Costa Osanan, Maria Fernanda Escobar Vidarte, Jack Ludmir

Department of Obstetrics and Gynecology Faculty Papers

No abstract provided.

Elagolix Treatment For Up To 12 Months In Women With Heavy Menstrual Bleeding And Uterine Leiomyomas, James A Simon, Ayman Al-Hendy, David F Archer, Kurt T Barnhart, Linda D Bradley, Bruce R Carr, Thomas Dayspring, Eve C Feinberg, Veronica Gillispie, Sandra Hurtado, Jinhee Kim, Ran Liu, Charlotte D Owens, Ozgul Muneyyirci-Delale, Alice Wang, Nelson B Watts, William Schlaff

Department of Obstetrics and Gynecology Faculty Papers

Objective: To investigate the safety and efficacy of elagolix, an oral gonadotropin-releasing hormone antagonist, with hormonal add-back therapy for up to 12 months in women with heavy menstrual bleeding associated with uterine leiomyomas.

Methods: Elaris UF-EXTEND was a phase 3 extension study that evaluated an additional 6 months (up to 12 months total) of elagolix 300 mg twice daily with hormonal add-back therapy (estradiol 1 mg and norethindrone acetate 0.5 mg once daily) in women who completed an initial 6 months of the same treatment in one of two preceding phase 3 studies. The primary endpoint was the percentage of …

Development Of An Abbreviated Symptom Score For The Neonatal Abstinence Syndrome., I. Chervoneva, S. C. Adeniyi-Jones, F. Blanco, W. K. Kraft

Department of Pharmacology and Experimental Therapeutics Faculty Papers

OBJECTIVE: We sought a shortened MOTHER neonatal abstinence syndrome (NAS) and Finnegan score that would retain comparable performance characteristics of the full instrument.

STUDY DESIGN: Retrospective cohort.

RESULTS: In total, 124,170 MOTHER NAS scores between August 2007 and May 2016 from 775 infants (≥36 weeks) were examined. Classification and regression tree model identified the most important subsets of the scored variables. A 9-element shortened scale yielded >90% sensitivity and specificity to predict clinical endpoints based on the full 19-element MOTHER NAS score. Conversion of the data sets to the Finnegan score, and applying the same procedure resulted in a nine-element …

Preconception Nutrition Intervention Improved Birth Length And Reduced Stunting And Wasting In Newborns In South Asia: The Women First Randomized Controlled Trial., Sangappa M Dhaded, K. Michael Hambidge, Sumera Aziz Ali, Manjunath Somannavar, Sarah Saleem, Omrana Pasha, Umber Khan, Veena Herekar, Sunil Vernekar, S. Yogesh Kumar, Jamie E. Westcott, Vanessa R. Thorsten, Amaanti Sridhar, Abhik Das, Elizabeth Mcclure, Richard J. Derman, Robert L. Goldenberg, Marion Koso-Thomas, Shivaprasad S. Goudar, Nancy F. Krebs

Global Health Articles

South Asia has >50% of the global burden of low birth weight (LBW). The objective was to determine the extent to which maternal nutrition interventions commenced before conception or in the 1st trimester improved fetal growth in this region. This was a secondary analysis of combined newborn anthropometric data for the South Asian sites (India and Pakistan) in the Women First Preconception Maternal Nutrition Trial. Participants were 972 newborn of mothers who were poor, rural, unselected on basis of nutritional status, and had been randomized to receive a daily lipid-based micronutrient supplement commencing ≥3 months prior to conception (Arm 1), …

Low-Dose Aspirin For The Prevention Of Preterm Delivery In Nulliparous Women With A Singleton Pregnancy (Aspirin): A Randomised, Double-Blind, Placebo-Controlled Trial., Matthew K. Hoffman, Shivaprasad S. Goudar, Bhalachandra S. Kodkany, Mrityunjay Metgud, Manjunath Somannavar, Jean Okitawutshu, Adrien Lokangaka, Antoinette Tshefu, Carl L. Bose, Abigail Mwapule, Musaku Mwenechanya, Elwyn Chomba, Waldemar A. Carlo, Javier Chicuy, Lester Figueroa, Ana Garces, Nancy F. Krebs, Saleem Jessani, Farnaz Zehra, Sarah Saleem, Robert L. Goldenberg, Kunal Kurhe, Prabir Das, Archana Patel, Patricia L. Hibberd, Emmah Achieng, Paul Nyongesa, Fabian Esamai, Edward A. Liechty, Norman Goco, Jennifer Hemingway-Foday, Janet Moore, Tracy L. Nolen, Elizabeth M. Mcclure, Marion Koso-Thomas, Menachem Miodovnik, R. Silver, Richard J. Derman, Aspirin Study Group

Global Health Articles

BACKGROUND: Preterm birth remains a common cause of neonatal mortality, with a disproportionately high burden in low-income and middle-income countries. Meta-analyses of low-dose aspirin to prevent pre-eclampsia suggest that the incidence of preterm birth might also be decreased, particularly if initiated before 16 weeks of gestation.

METHODS: ASPIRIN was a randomised, multicountry, double-masked, placebo-controlled trial of low-dose aspirin (81 mg daily) initiated between 6 weeks and 0 days of pregnancy, and 13 weeks and 6 days of pregnancy, in nulliparous women with an ultrasound confirming gestational age and a singleton viable pregnancy. Participants were enrolled at seven community sites in …

Elagolix For Heavy Menstrual Bleeding In Women With Uterine Fibroids., William D. Schlaff, Ronald T. Ackerman, Ayman Al-Hendy, David F. Archer, Kurt T. Barnhart, Linda D. Bradley, Bruce R. Carr, Eve C. Feinberg, Sandra M. Hurtado, Jinhee Kim, Ran Liu, R. Garn Mabey, Charlotte D. Owens, Alfred Poindexter, Elizabeth E. Puscheck, Henry Rodriguez-Ginorio, James A. Simon, Ahmed M. Soliman, Elizabeth A. Stewart, Nelson B. Watts, Ozgul Muneyyirci-Delale

Department of Obstetrics and Gynecology Faculty Papers

BACKGROUND: Uterine fibroids are hormone-responsive neoplasms that are associated with heavy menstrual bleeding. Elagolix, an oral gonadotropin-releasing hormone antagonist resulting in rapid, reversible suppression of ovarian sex hormones, may reduce fibroid-associated bleeding.

METHODS: We conducted two identical, double-blind, randomized, placebo-controlled, 6-month phase 3 trials (Elaris Uterine Fibroids 1 and 2 [UF-1 and UF-2]) to evaluate the efficacy and safety of elagolix at a dose of 300 mg twice daily with hormonal "add-back" therapy (to replace reduced levels of endogenous hormones; in this case, estradiol, 1 mg, and norethindrone acetate, 0.5 mg, once daily) in women with fibroid-associated bleeding. An elagolix-alone …