Author Interviews, Infections, OBGYNE, Pediatrics / 26.11.2020

MedicalResearch.com Interview with: [caption id="attachment_55957" align="alignleft" width="200"]Jessica Miller PhD Postdoc Fellow Murdoch Childrens Research Institute Dr. Miller[/caption] Jessica Miller PhD Postdoc Fellow Murdoch Childrens Research Institute  MedicalResearch.com: What is the background for this study? Response: Cesarean section (CS) may be a lifesaving intervention for women and babies. However, the global proportion of CS births is rapidly increasing and may not be medically justified. As CS has implications for both mother and child, the increasing rates warrant population-level analyses of potential risks. Many suggested long-term outcomes in CS-born children relate to altered immune development. It is possible that differences in the newborn microbiome by mode of birth contribute to the development of early immune responses which may influence the risk of immune-related outcomes, including infection. CS has been associated with an increased risk for specific infection-related hospitalisations, mainly lower respiratory tract and gastrointestinal infections, but it remains unclear whether CS is associated with increased risk of overall infection-related hospitalisation or only certain infection types, and whether risk differs for emergency versus elective/pre-labour CS.
Author Interviews, BMJ, Brigham & Women's - Harvard, Fertility, OBGYNE / 19.11.2020

MedicalResearch.com Interview with: [caption id="attachment_55925" align="alignleft" width="200"]Jennifer Yland, MS Department of Epidemiology Boston University School of Public Health Jennifer Yland[/caption] Jennifer Yland Doctoral Student in Epidemiology Harvard T.H. Chan School of Public Health MedicalResearch.com: What is the background for this study? Response: Worldwide, about 22% of reproductive-aged women used hormonal contraception last year. Long-acting reversible contraceptive (LARC) methods, which include intrauterine devices (IUDs), implants, patches, and injectable contraceptives, have become increasingly popular. However, little is known about the return to fertility after use of different contraceptives, particularly LARC methods.
Author Interviews, Columbia, JAMA, OBGYNE, Weight Research / 05.11.2020

MedicalResearch.com Interview with: [caption id="attachment_55855" align="alignleft" width="139"]Dr-Marissa-N-Spann Dr. Spann[/caption] Marisa N. Spann, PhD, MPH Columbia University Irving Medical Center New York, New York MedicalResearch.com: What is the background for this study? Response: Prior research has demonstrated that higher maternal pre-pregnancy body mass index is associated with adverse long-term outcomes for offspring including obesity, poorer cognitive and social abilities, and increased risk of psychiatric disorders.  MedicalResearch.com: What are the main findings? Response: In this study, we investigated the association of maternal pre-pregnancy body mass index with fetal growth and neonatal functional connectivity and found that maternal pre-pregnancy BMI has a significant positive correlation with fetal weight and with greater thalamic connectivity of the brain. 
Author Interviews, Exercise - Fitness, OBGYNE, Weight Research / 30.10.2020

MedicalResearch.com Interview with: Suvi Ravi Faculty of Sport and Health Sciences University of Jyväskylä Jyväskylä, Finland MedicalResearch.com: What is the background for this study? Response: The results of studies comparing the prevalence of menstrual dysfunction in athletes and non-athletes have been inconsistent. Menstrual dysfunction can have many different causes but one of the most common in athletes is low energy availability (i.e., inadequate energy intake relative to energy expenditure). Disordered eating/eating disorder as a result of e.g. body weight dissatisfaction, which is the discrepancy between actual and desired weight, can be a risk factor for inadequate energy intake and thus could play a role in menstrual dysfunction. We studied a cohort of athletes and non-athletes, in adolescence (14-16 years) and subsequently in young adulthood (18-20 years) to determine the prevalence of menstrual dysfunction and body weight dissatisfaction. Menstrual dysfunction in our study was defined as primary amenorrhea, which is the absence of menses by the age of 15, prolonged menstrual cycle (>35 days), or secondary amenorrhea i.e., absence of menses for at least three consecutive months. 
Author Interviews, Fertility, Genetic Research, OBGYNE, Technology / 29.10.2020

MedicalResearch.com Interview with: PGT-A & ARTIFICIAL INTELLIGENCE IMPROVES PREGNANCY OUTCOMES FOR PATIENTS UNDERGOING IVF MedicalResearch.com Interview with: Michael Large, PhD Senior Director, Research at CooperGenomics CooperSurgical MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Large: Independent study results, presented at the recent the American Society of Reproductive Medicine (ASRM) Virtual Scientific Congress, demonstrated a 13 percent relative increase in ongoing pregnancy and live birth rates associated with the use of CooperSurgical’s PGTaiSM 2.0 technology to screen embryos for in vitro fertilization (IVF). The single-center study was conducted by NYU Langone Fertility Center (NYULFC), part of The Prelude Network. Preimplantation Genetic Testing for aneuploidy (PGT-A) is performed on embryos produced through IVF; it provides genetic information to help identify embryos that are more likely to result in a successful pregnancy. PGTai 2.0 technology is an advancement in PGT-A testing platform that utilizes artificial intelligence to increase objectivity of this screening process. The study compared results from three next generation sequencing (NGS) genetic tests: Standard NGS, NGS with first generation artificial intelligence (PGTai 1.0 Technology Platform) and NGS with second generation artificial intelligence (PGTai 2.0 Technology Platform). The ongoing pregnancy and live birth rates significantly increased by a relative 13 percent in the PGTai 2.0 group as compared to subjective and prior methodologies. Study results also suggest that the increase in ongoing pregnancy and live births may be linked to improvements in several preceding IVF outcomes (implantation rates, clinical pregnancy rates and pregnancy loss.) MedicalResearch.com: What should readers take away from your report? Dr. Large: This research moves us an important step closer to our goal of increased live births, improved pregnancy outcomes and further reduction of multiples in pregnancy through greater confidence in single embryo transfer. An estimated 48.5 million couples – approximately 15% of couples -- are affected by infertility worldwide. 80,000 babies were born with IVF in 2017 in the United States and more than one million babies were born in the period 1987 to 2015 in the United States as a result of IVF. MedicalResearch.com: What recommendations do you have for future research this study? Dr. Large: The goal of PGT-A is to decrease risk and maximize the chances of IFV success by screening for embryos with the highest potential. This was precisely what NYULFC have observed so far with PGTai 2.0 compared to older technologies. To fully appreciate the impact that these improvements are having for patients, we’re excited to hear from additional IVF centers across the world as they utilize this technology. MedicalResearch.com: Is there anything else you would like to add? Any disclosures? Dr. Large: The study demonstrates CooperSurgical’s commitment to developing the most advanced technology in the field of genetic testing to advance reproductive medicine and help families. By applying artificial intelligence in the PGTaism2.0 technology, we leverage mathematical algorithms derived from real-world data to achieve objective embryo assessment. I am the Senior Director of Genomics Research and Development at CooperSurgical. Michael Large, PhD, is the Senior Director, Genomics Research and Development at CooperSurgical. His team recently led and continues to develop state-of-the-art analytical methods for interrogating Reproductive Genetics. Dr. Large earned his PhD in Cell and Molecular Biology from the Baylor College of Medicine and his Bachelor of Science in Cell and Molecular Biology from the University of Wisconsin – La Crosse. Michael Large, PhD Senior Director, Research at CooperGenomics CooperSurgical   MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Large: Independent study results, presented at the recent the American Society of Reproductive Medicine (ASRM) Virtual Scientific Congress, demonstrated a 13 percent relative increase in ongoing pregnancy and live birth rates associated with the use of CooperSurgical’s PGTaiSM 2.0 technology to screen embryos for in vitro fertilization (IVF).[1] The single-center study was conducted by NYU Langone Fertility Center (NYULFC), part of The Prelude Network. Preimplantation Genetic Testing for aneuploidy (PGT-A) is performed on embryos produced through IVF; it provides genetic information to help identify embryos that are more likely to result in a successful pregnancy. PGTai 2.0 technology is an advancement in PGT-A testing platform that utilizes artificial intelligence to increase objectivity of this screening process. The study compared results from three next generation sequencing (NGS) genetic tests: Standard NGS, NGS with first generation artificial intelligence (PGTai 1.0 Technology Platform) and NGS with second generation artificial intelligence (PGTai 2.0 Technology Platform). The ongoing pregnancy and live birth rates significantly increased by a relative 13 percent in the PGTai 2.0 group as compared to subjective and prior methodologies. Study results also suggest that the increase in ongoing pregnancy and live births may be linked to improvements in several preceding IVF outcomes (implantation rates, clinical pregnancy rates and pregnancy loss.)
Author Interviews, Fertility, OBGYNE / 30.09.2020

MedicalResearch.com Interview with: Dr. Liron Rozenkrantz Postdoctoral Fellow Department of Brain and Cognitive Sciences, Massachusetts Institute of Technology Program in Placebo Studies, Harvard Medical School Former PhD student at Human Olfaction Research group, Department of Neurobiology Weizmann Institute of Science Reut Weissgross Research student Human Olfaction Research group, Department of Neurobiology Weizmann Institute of Science MedicalResearch.com: What is the background for this study? Response: A pregnancy loss is not such a rare event as you would think: it is estimated that about 50% of all conceptions (or 15% of the documented pregnancies) end in spontaneous miscarriage. About 1-2% of all couples trying to conceive will experience recurrent pregnancy loss (RPL), meaning 2-3 consecutive miscarriages, and despite going through numerous clinical investigations (hormonal tests, genetics and so) - about half of these cases will remain unexplained. This devastating phenomenon leaves couples with no explanation as to why they cannot bear a child. While most research in this field is focused on the reproductive organs (mainly the uterus), hormones and genes, we set out to look for new possible routes. The literature regarding the tight connection between olfaction and reproduction, mainly by social body-odors (or pheromones), is heavily documented, especially in rodents. Body-odors emitted from males affect pubertal development of juvenile female rodents and estrus cycle, and females body odors affect other females’ fertility state. The most robust phenomenon in this relation is the Bruce effect, in which pregnant female mice who are exposed to body-odors from a non-stud male - will experience impanation failure in 80% of exposures! Since there is growing evidence for the involvement of the olfactory system in human reproduction, we asked whether the olfactory system is also involved in human reproductive disorders such as unexplained recurrent pregnancy loss (uRPL). To answer this question, we recruited 40 women experiencing uRPL and 57 matched controls (who never experienced a miscarriage, and are at similar age to the uRPL women), and compared their olfactory profile, mainly in response to men’s body-odors.
Author Interviews, Cannabis, JAMA, OBGYNE, Pediatrics / 25.09.2020

MedicalResearch.com Interview with: Sarah E. Paul, BA , Graduate Student and Ryan Bogdan, PhD, Associate Professor BRAIN Lab Washington University in St. Louis St. Louis, MO 63130 MedicalResearch.com: What is the background for this study? Sarah Paul: This study was motivated by several trends in cannabis use, its legal landscape, and people's perception of risk. As more states legalize recreational cannabis use, cannabis has become more accessible as well as more potent. Over the past couple of decades, the percentage of adolescents and adults who think that cannabis use is risky or harmful has fallen substantially. Cannabis dispensaries have been reported to actually recommend cannabis to pregnant women for the treatment of pregnancy-related nausea. And finally, between 2002/2003 and 2016/2017, the percentage of women reporting cannabis use during their pregnancies rose 106%. Given these trends and the mixed literature regarding the potential consequences associated with prenatal cannabis exposure, we aimed to comprehensively examine a range of outcomes in a large, representative sample while accounting for a host of important potentially confounding covariates.
Author Interviews, Coffee, OBGYNE / 25.08.2020

MedicalResearch.com Interview with: [caption id="attachment_55208" align="alignleft" width="128"]Professor Jack E. James, PhD Reykjavík University Reykjavík Iceland Prof. James[/caption] Professor Jack E. James, PhD Reykjavík University Reykjavík Iceland  MedicalResearch.com: What prompted this study?  Response: Chronic exposure to any chemical during pregnancy is cause for concern. There should be no exception simply because that chemical, caffeine, happens to be widely consumed. Caffeine is a habit-forming substance of no nutritional value. If anything, its widespread consumption suggests that it should be given special attention. Concern is heightened by what is known about the effects of caffeine on the human body, where it affects neural processes in the brain, including networks that control respiration and heart function. When consumed during pregnancy, caffeine readily crosses the placenta, exposing the fetus to the drug. Notably, the fetus is largely physically incapable of metabolising caffeine – that ability develops during the first year of life. Pregnancy studies have shown that caffeine can interfere with fetal heart function and oxygenation. 
Author Interviews, NEJM, OBGYNE, Surgical Research / 29.07.2020

MedicalResearch.com Interview with: Jane Daniels PhD Professor of Clinical Trials, Faculty of Medicine & Health Sciences School of Medicine University of Nottingham MedicalResearch.com: What is the background for this study? MedicalResearch.com: What are the main findings? [caption id="attachment_54976" align="alignleft" width="200"]One example of a large fibroid-Wikipedia image One example of a large fibroid-Wikipedia image[/caption] Response: Uterine fibroids are the most common non-cancerous tumour in women of childbearing age. They are associated with heavy bleeding, lower chances of having children and reduced quality of life. Traditional surgical options were either to remove the fibroids (myomectomy) or completely remove the womb. A newer approach, known as uterine artery embolization, involves blocking the blood supply to the fibroids in the womb. Fibroids may be associated with infertility and problems during pregnancy, including miscarriage and preterm birth. As more women are having children at a later age, fibroids are becoming more of an issue for them and safe and effective fertility sparing treatments are needed. Both treatments improve quality of life, but myomectomy will provide greater benefit to women on average. MedicalResearch.com: What should readers take away from your report? Response: This study is the largest to date comparing women treated with either myomectomy or uterine-artery embolization for their fibroids. It was completed in hospitals across the UK, and included a substantial number of women of African-Caribbean ethnicity, who are more likely have bothersome fibroids, so we can be confident that the findings are important and relevant. Women, including those desiring a future pregnancy, should be provided with the evidence generated by the FEMME trial to enable to make a fully informed decision regarding their fibroid treatment.
Author Interviews, OBGYNE / 30.06.2020

MedicalResearch.com Interview with: Prof Roger Gadsby MBE Honorary Associate Clinical Professor Warwick Medical School University of Warwick MedicalResearch.com: What is the background for this study? Response: The term "morning sickness" is widely used to describe the nausea and vomiting symptoms that occur in pregnancy. Previous research has reported that symptoms can occur both before and after midday but little has been published describing the daily and weekly pattern of symptoms. MedicalResearch.com: What are the main findings? Response: Using a database of 256 women who kept daily symptom diaries from the onset of symptoms till around 7 weeks of pregnancy, the study modeled the daily symptom patterns and changes in daily patterns by week of pregnancy. Nausea occurred throughout the day. Vomiting had a defined peak in the morning, but can occur throughout the day
Abbvie, Author Interviews, OBGYNE / 16.06.2020

MedicalResearch.com Interview with: https://www.abbvie.com/   Ayman Al-Hendy, M.D., Ph.D. Investigator for the ELARIS UF-2 clinical trials Professor of Gynecology Director of Translational Research University of Illinois at Chicago   Dr. Al-Hendy discusses the recent announcement that the FDA has approved  ORIAHNN™ for the management of heavy menstrual bleeding due to uterine fibroids in pre-menopausal women. [caption id="attachment_54598" align="alignleft" width="150"]Ayman Al-Hendy, M.D., Ph.D. Investigator for the ELARIS UF-2 clinical trials Professor of Gynecology Director of Translational Research University of Illinois at Chicago Dr. Al-Hendy[/caption] MedicalResearch.com: What is the background for this approval? Uterine fibroids, commonly referred to as uterine leiomyomas, are the most common type of non-cancerous tumor known to impact women of reproductive age (30-50 years old). In fact, studies show that uterine fibroids can occur in up to 70 percent of European American women and over 80 percent of African American women by age 50. As a result of uterine fibroids, women can experience a range of symptoms, the most common being heavy menstrual bleeding (i.e. prolonged and/or frequent bleeding), which can lead to other health effects such as anemia, fatigue, pelvic pain, urinary frequency etc. Uterine fibroid treatment recommendations have historically been based on the size and location of the fibroid(s). When treating larger and more complicated fibroids, healthcare providers have typically believed that surgery is their best course of action, which has made uterine fibroids the leading reason for the hysterectomies performed in the U.S. The FDA approval of ORIAHNN was based on improving care for uterine fibroid sufferers who have had a negative impact on their quality of life due to disruptive symptoms. What makes the approval of ORIAHNN so exciting, is that women now have an oral therapy to directly address heavy menstrual bleeding due to uterine fibroids. 
ASCO, Author Interviews, OBGYNE, Ovarian Cancer / 12.06.2020

MedicalResearch.com Interview with: [caption id="attachment_54506" align="alignleft" width="140"]Robert L. Coleman, MD, FACOG, FACS Chief Scientific Officer US Oncology Research Dr. Coleman[/caption] Robert L. Coleman, MD, FACOG, FACS Chief Scientific Officer US Oncology Research MedicalResearch.com: What is the background for this study? Response: For years, there has been general support for surgery in patients with recurrent ovarian cancer supported by reams of retrospective studies that suggest patients live longer if they have surgery preceding chemotherapy. Suggested hypotheses from these trials were that patients most likely to benefit from the procedure were those with good performance status (could tolerate the procedure), had long platinum-free interval (surrogate for potential for chemotherapy response) and those in whom all disease could be resected. Each of these are also characteristics that would portend a good prognostic cohort in general and would likely do better than other patients without these characteristics. So there was a strong selection bias in these retrospective surveys. Thus, the call for randomized trials. GOG-213 was launched in 2007 with 2 primary endpoints: 1. Determine the impact of adding bevacizumab to paclitaxel/carboplatin in patients with platinum-sensitive recurrent ovarian cancer, and 2. Determine if surgery increases overall survival.
Author Interviews, JAMA, OBGYNE, Pediatrics / 11.06.2020

MedicalResearch.com Interview with: [caption id="attachment_54494" align="alignleft" width="199"]Colm Travers, M.D., MSPH Assistant Professor Department of Pediatrics University of Alabama at Birmingham Dr. Travers[/caption] Colm Travers, M.D., MSPH Assistant Professor Department of Pediatrics University of Alabama at Birmingham MedicalResearch.com: What is the background for this study? Response: It is known that black mothers are much more likely to deliver preterm and low birth weight infants. The purpose of this study was to determine whether racial/ethnic disparities in care practices and outcomes were decreasing or increasing among extremely preterm infants. These are infants born from 22 to 27 weeks of gestation who have a high risk of death and major illnesses. 
Allergies, Author Interviews, JAMA, OBGYNE / 05.06.2020

MedicalResearch.com Interview with: Niklas Andersson MS Department of Epidemiology Research Statens Serum Institut Copenhagen S, Denmark MedicalResearch.com: What is the background for this study? What are the main findings? Response: Second-generation antihistamines are among the most commonly prescribed drug classes during pregnancy. Fexofenadine is a widely used antihistamine but given the limited fetal safety on the use of antihistamines during pregnancy in general, current clinical guidelines only recommend the use cetirizine and loratadine during pregnancy when needed due to a larger body of fetal safety data for these antihistamines.
Author Interviews, JAMA, OBGYNE / 05.06.2020

MedicalResearch.com Interview with: Anjali Kaimal, MD, MAS, Maternal-Fetal Medicine Specialist Associate Professor in the Departments of Obstetrics Massachusetts General Hospital Miriam Kuppermann, PhD, MPH Professor Vice Chair Clinical and Translational Research Director Program for Clinical Perinatal UCSF MedicalResearch.com: What is the background for this study? What are the main findings? Response: Reducing the rate of cesarean delivery is an important public health goal.  Nearly one third (31.9%) of deliveries in the US are via cesarean, and dramatic increases in the cesarean rate since the 1990s have been associated with substantial increases in maternal morbidity.  One of the reasons for the increased rate of cesarean delivery is the decreasing rate at which women attempt to have a vaginal birth after cesarean (VBAC).  Although having a “trial of labor” (in the hopes of giving birth vaginally) after cesarean is safe, and many women say they would prefer a vaginal delivery, most women who have had a previous cesarean plan a scheduled repeat cesarean delivery.  While some hospitals do not offer trial of labor after cesarean, even at institutions where this is an option. VBAC rates remain low. We created a patient-facing “decision tool” that provides detailed information on both trial of labor and scheduled repeat cesarean, a personalized risk assessment of the likelihood that the a trial of labor would end in a VBAC, and a series of values clarification exercises, to help women think through their options and engaged in informed, shared decision making with their providers.  We then conducted a randomized study in three geographic areas (San Francisco, Boston, and Chicago) to determine whether use of the decision tool affected rates of trial of labor and vaginal birth after cesarean, as well as several aspects of decision quality (knowledge, shared decision making, decisional conflict, and decision satisfaction).  
Author Interviews, CMAJ, Endocrinology, OBGYNE / 02.06.2020

MedicalResearch.com Interview with: [caption id="attachment_54421" align="alignleft" width="200"]Lois Donovan MD FRCPC Clinical Professor Cumming School of Medicine Division on Endocrinology and Metabolism and Department of Obstetrics and Gynecology University of Calgary Dr. Donovan[/caption] Lois Donovan MD FRCPC Clinical Professor Cumming School of Medicine Division on Endocrinology and Metabolism and Department of Obstetrics and Gynecology University of Calgary MedicalResearch.com: What is the background for this study? 1) We observed in our clinical practices that minor TSH elevations in early pregnancy frequently normalized without intervention. 2) Recent randomized control trials have failed to show benefit of treating women with levothyroxine with minor TSH elevations in pregnancy 
Author Interviews, JAMA, OBGYNE, Pediatrics / 01.06.2020

MedicalResearch.com Interview with: Katri RäikkönenKatri Räikkönen Professor, Department of Psychology and Logopedics University of Helsinski MedicalResearch.com: What is the background for this study? Response: Maternal antenatal corticosteroid treatment is standard care when there is a risk for preterm delivery. The treatment improves the prognosis of babies born preterm. In high-income countries, antenatal corticosteroid treatment has been in routine use for over 30 years. Recommendations and clinical care guidelines for maternal antenatal corticosteroid treatment differ between continents and countries. In Finland the treatment is currently recommended when the risk for preterm delivery is at 34 gestational weeks or less. In select cases, the treatment is recommended even later in gestation. Corticosteroids accelerate fetal maturation, especially in the lungs, and increase the child’s resilience to the stress that results from being born preterm. However, antenatal corticosteroids not only cross the placenta, but also cross the the blood-brain barrier and may harm fetal brain development. We are not aware of previous population-based studies that would have tested if maternal antenatal corticosteroid treatment would be associated with mental and behavioral disorders in children and we are not either aware of studies that would have tested if any associations would be explained by shared genetic or familial factors.
Author Interviews, OBGYNE, Pediatrics / 21.05.2020

MedicalResearch.com Interview with: [caption id="attachment_54306" align="alignleft" width="200"] Dr. Zhu[/caption] Yanmin Zhu, M.S., Ph.D. Postdoctoral Research Fellow Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women's Hospital and Harvard Medical School  MedicalResearch.com: What is the background for this study? Response: Animal studies and case reports suggest a potential teratogenic effect associated with the use of high doses of fluconazole during pregnancy. The malformations reported in case reports have a distinct phenotype, including femoral bowing, thin ribs, cleft palate, and abnormal craniofacial ossification. A few controlled studies have examined the risk of congenital malformations associated with the use of fluconazole during the first trimester, but findings are inconsistent.
Author Interviews, Infections, OBGYNE / 16.05.2020

MedicalResearch.com Interview with: SCYNEXIS IncMarco Taglietti, M.D. President and Chief Executive Officer SCYNEXIS Inc Dr. Taglietti discusses SCYNEXIS’ announcement of positive results from its second Phase 3 study investigating the safety and efficacy of oral ibrexafungerp as a treatment for vaginal yeast infection.  [caption id="attachment_54239" align="alignleft" width="200"]Marco Taglietti, M.D. President and Chief Executive Officer SCYNEXIS Inc Dr. Taglietti[/caption] MedicalResearch.com: What is the background for this study? Response:  The VANISH-306 study is one of two Phase 3 randomized, double-blind, placebo-controlled, multi-center studies designed to demonstrate the superiority of oral ibrexafungerp to placebo as a treatment of vaginal yeast infections, also known as vulvovaginal candidiasis. Ibrexafungerp is a novel oral/intraveneous broad-spectrum antifungal in late stage development for multiple indications, from the treatment and prevention of vaginal yeast infections to life-threatening invasive fungal infections in the hospital setting. The VANISH-306 study was conducted in 42 centers in the US and EU and enrolled 449 patients. Patients were randomized to oral ibrexafungerp (two doses of 300mg taken 12 hours apart for one day) or placebo in a 2:1 ratio The primary endpoints included clinical cure rate, defined as the complete resolution of all signs and symptoms at the test-of-cure visit (Day-10) and secondary endpoints included mycological eradication and change in signs and symptoms scores compared to baseline at both day 10 and follow-up visit (Day-25). The VANISH-306 study reported positive topline data which showed that 63.3% of ibrexafungerp-treated patients saw a complete resolution of signs and symptoms 10 days following a single day dose of ibrexafungerp. The first study in the VANISH program was VANISH-303, a US-based study, had an identical design to the VANISH-306 study. The VANISH-303 study reported positive topline data in November 2019 which showed that 50.5% of ibrexafungerp-treated patients saw a complete resolution of signs and symptoms 10 days following a single day dose of ibrexafungerp. Both VANISH studies showed a highly significant statistical difference in the primary and secondary efficacy endpoints. The product was well tolerated.
Author Interviews, Infections, OBGYNE, Sexual Health, STD / 13.05.2020

MedicalResearch.com Interview with: [caption id="attachment_54202" align="alignleft" width="200"]Gregory Kaufman, M.D. Senior Vice President Global Clinical and Medical Affairs Specialty at Lupin Dr. Kaufman[/caption] Gregory Kaufman, M.D. Senior Vice President Global Clinical and Medical Affairs Specialty at Lupin MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by trichomoniasis?  How common is this infection? Response: The Phase 3 trial evaluated the effectiveness and safety of a single oral dose of Solosec® (secnidazole) 2g oral granules for the treatment of trichomoniasis in adult women. Top-line results were positive and showed that Solosec was generally well-tolerated. Trichomoniasis is the most common non-viral sexually transmitted infection (STI) in the U.S., and is caused by a protozoan parasite called Trichomonas vaginalis.[i] Trichomoniasis affects 3 to 5 million people in the U.S.,[ii] and is four- to five-times more prevalent in in women, compared to men.[iii].
Author Interviews, Endocrinology, OBGYNE / 14.04.2020

MedicalResearch.com Interview with: “Open Space Yoga Hawaii” by Open Space Yoga Hawaii is licensed under CC BY 2.0Diana Speelman, Ph.D. Director of Research for the College of Medicine Associate Professor of Biochemistry Reproductive System Course Coordinator L|E|C|O|M Erie, PA 16509 MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by PCOS? Response: Polycystic ovary syndrome (PCOS) is the most common hormone disorder in women of reproductive age.  It is characterized by high androgen levels (e.g., testosterone) in the blood and irregular menstrual cycles.  Despite affecting 5-15% of women, its cause is unknown.  While medications can be used to reduce androgen levels, or help achieve menstrual regularity or stimulate ovulation, these often have undesirable side effects.  Our goal was to investigate the effectiveness of non-pharmacologic approaches, including yoga, on improving the characteristics associated with the disorder. 
Anesthesiology, Author Interviews, COVID -19 Coronavirus, OBGYNE / 13.04.2020

MedicalResearch.com Interview with: [caption id="attachment_53884" align="alignleft" width="242"]Dr. Alicia Warlick, MD Anesthesiologist at UNC/Rex, American Anesthesiology Raleigh, North Carolina Dr. Warlick[/caption] Dr. Alicia Warlick, MD Anesthesiologist at UNC/Rex, American Anesthesiology Raleigh, North Carolina MedicalResearch.com: As a physician working on the frontlines of the COVID-19 battle, how are you addressing expecting mothers’ concerns about the disease and how it might impact their pregnancy? Response: While COVID-19 has disrupted nearly every aspect of healthcare, whether its virtual appointments or delayed surgeries; there are certain things that are inevitable – like childbirth. As this virus continues to take over the country and we learn more about it each day, pregnant women are facing new challenges and fears. For women approaching their due dates, questions about staying healthy, keeping their baby safe and limiting their risk of exposure while in the hospital are all leading to anxiety and stress. And while policies and guidelines are constantly changing, as physicians we need to remind our patients that we are there to alleviate their concerns, address their questions and remind them to not lose sight of the joy the comes with bringing a child into the world. It’s a scary time for everyone, but by working together and supporting one another, we will get through this.
Author Interviews, Diabetes, Kidney Disease, OBGYNE, Race/Ethnic Diversity / 30.03.2020

MedicalResearch.com Interview with: [caption id="attachment_53689" align="alignleft" width="155"]Silvi Shah, MD, MS, FACP, FNKF, FASN Assistant Professor Division of Nephrology, University of Cincinnati Cincinnati, OH-45267 Dr. Shah[/caption] Silvi Shah, MD, MS, FACP, FNKF, FASN Assistant Professor Division of Nephrology University of Cincinnati Cincinnati, OH-45267 MedicalResearch.com: What is the background for this study? Response: The study identified 42,190,790 pregnancy related hospitalizations between Jan. 1, 2006 and Dec. 31, 2015, using data from the from the Nationwide Inpatient Sample.
Author Interviews, Cancer Research, Columbia, OBGYNE / 11.03.2020

MedicalResearch.com Interview with: [caption id="attachment_53473" align="alignleft" width="161"]Matthew E. Spotnitz, MD, MPH Departments of Biomedical Informatics and Obstetrics and Gynecology Columbia University Medical Center, Observational Health Data Sciences and Informatics, and Medical Informatics Services New York-Presbyterian Hospital, New York, New York Dr. Spotnitz[/caption] Matthew E. Spotnitz, MD, MPH Departments of Biomedical Informatics and Obstetrics and Gynecology Columbia University Medical Center Observational Health Data Sciences and Informatics, and Medical Informatics Services New York-Presbyterian Hospital, New York, New York MedicalResearch.com: What is the background for this study? Response: Our take home message is that copper and hormonal IUDs may have different physiological effects on the female genitourinary system.
Author Interviews, Fertility, Heart Disease, JAMA, OBGYNE / 27.02.2020

MedicalResearch.com Interview with: Shi Wu Wen PhD Senior Scientist, Clinical Epidemiology Program Professor, Department of Obstetrics & Gynecology University of Ottawa MedicalResearch.com: What is the background for this study? Response: Previous studies have shown that having a baby as a result of using assisted procedures such as IVF nearly doubles the chance that a baby will have heart problems.
Author Interviews, OBGYNE, Pediatrics / 04.02.2020

MedicalResearch.com Interview with: [caption id="attachment_53073" align="alignleft" width="179"]Andrea M. Tilstra Doctoral Candidate, Department of Sociology Population Program, Institute of Behavioral Science University of Colorado Boulder Andrea Tilstra[/caption] Andrea M. Tilstra Doctoral Candidate, Department of Sociology Population Program, Institute of Behavioral Science University of Colorado Boulder MedicalResearch.com: What is the background for this study? Response: Average U.S. birth weight declined across the 1990s and 2000s, and this has puzzled most researchers. We investigate this and find that the increases in cesarean deliveries and induction of labor between 1990 and 2013 resulted in a shift in the gestational age distribution of U.S. births. We find that births are less likely to occur at gestational weeks 40+ and much more likely to occur between weeks 37-39. Additionally, results from our simulations show that if U.S. rates of cesarean deliveries and labor induction had not increased over time, then average birth weight would have increased.  
Author Interviews, OBGYNE, Opiods, Pain Research / 28.01.2020

MedicalResearch.com Interview with: [caption id="attachment_52986" align="alignleft" width="140"]Dave Stack Chief Executive Officer and Chairman Pacira BioSciences David Stack[/caption] Dave Stack Chief Executive Officer and Chairman Pacira BioSciences  MedicalResearch.com: What is the background for this study? Response: Cesarean sections (C-sections) are one of the most common surgeries in the United States, and research shows many women experience moderate to severe pain after this procedure. When postsurgical pain is inadequately managed for new mothers, it can interfere with recovery, maternal-infant bonding and may even lead to postpartum depression. Additionally, prescribing data reveals that postsurgical opioid consumption poses a great risk to women. We recently completed a Phase 4 study of EXPAREL in C-section patients, and results revealed adding EXPAREL to bupivacaine transversus abdominis plane (TAP) blocks for C-section delivery provided significant reductions in opioids and pain scores. Results of that study provided the basis for the design of this next-generation study, which was created to be completely opioid-free in the EXPAREL arm. The study was a Phase 4 multicenter, active-controlled study conducted in 18 clinical sites in the United States, with 169 enrolled patients undergoing elective C-section. The enrolled C-section patients were randomized to receive either 150 mcg morphine spinal anesthesia plus a standard of care postoperative pain regimen, 50 mcg morphine spinal anesthesia plus EXPAREL TAP field block, or opioid-free spinal anesthesia plus EXPAREL TAP block. Patients in the EXPAREL arms received a protocol-defined non-opioid postsurgical pain management regimen including ketorolac, acetaminophen, and ibuprofen. 
Abbvie, Author Interviews, NEJM, OBGYNE / 23.01.2020

MedicalResearch.com Interview with: [caption id="attachment_52895" align="alignleft" width="150"]William D Schlaff MD Chair, Department of Obstetrics & Gynecology Jefferson University Dr. Schlaff[/caption] William D Schlaff  MD Chair, Department of Obstetrics & Gynecology Jefferson University MedicalResearch.com: What is the background for this study? Response: Symptomatic uterine fibroids are the most common indication for hysterectomy in the US.  Heavy bleeding is the most common and troublesome symptom.  The primary treatment for this problem is surgery—either hysterectomy or (less commonly) myomectomy.  Medical treatment which reduces the bleeding related to fibroids without surgery is a valuable treatment for many women.  Existing medications include, most commonly GnRH agonists.  These are injectable medications that are given every 1 or 3 months (depending on the formulation) and have been shown to reduce bleeding related to fibroids.  They work by initially stimulating the ovaries to increase estrogen levels for 10-14 days before suppressing estrogen and thereby reducing bleeding.  Even though the medication is given every 1 or 3 months, the effect of the medication can last quite a bit longer; in cases of adverse response, the medication cannot be immediately stopped.  The medication reported in this trial, Elagolix, is a GnRH antagonist given by mouth twice daily and resulting in suppression of estrogen secretion within a matter of hours.  The effect of this medication wears off much more rapidly than the depot formulations described and can be stopped in the uncommon cases of adverse side effects. 
Author Interviews, OBGYNE, Pain Research / 17.01.2020

MedicalResearch.com Interview with: [caption id="attachment_52845" align="alignleft" width="200"]Rafael Maldonado Lopez MD PhD Full professor Departament de Ciències Experimentals i de la Salut Universitat Pompeu Fabra Barcelona Dr. Maldonado Lopez[/caption] Rafael Maldonado Lopez MD PhD Full professor Departament de Ciències Experimentals i de la Salut Universitat Pompeu Fabra Barcelona MedicalResearch.com: What is the background for this study? Response: Endometriosis is a common, chronic and painful disease caused when the endometrium grows outside of the uterine cavity. These growths mainly affect organs in the pelvis causing pain and infertility, symptoms that are often accompanied with anxiety, depression, loss of working ability, and a substantial impact on quality of life. Current treatments include hormonal therapy and surgery, but the effectiveness of these treatments is rather limited, often have important unwanted side effects, and patients usually rely on self-management strategies. Therefore, there is an urgent need for researching new possible therapeutic approaches.