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safety in pregnancy

Joel E Gallant, Graeme Moyle, Juan Berenguer, Peter Shalit, Huyen Cao, Ya-Pei Liu, Joel Myers, Lisa Rosenblatt, Lingfeng Yang, Javier Szwarcberg
OBJECTIVES: Cobicistat (COBI) enhances atazanavir (ATV) pharmacokinetic parameters similarly to ritonavir (RTV) in both healthy volunteers and HIV-infected adults. Primary efficacy and safety outcomes of this Phase 3, international, randomized, double-blind, double-dummy, active-controlled trial in HIV-1-infected treatment-naïve adults (GS-US-216-0114/NCT01108510) demonstrated that ATV+COBI was non-inferior to ATV+RTV, each in combination with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), at Weeks 48 and 144, with high rates of virologic success for both regimens (85...
October 21, 2016: Current HIV Research
Britta Wigginton, Coral Gartner, Ingrid J Rowlands
INTRODUCTION: Electronic cigarette (e-cigarette) use, or vaping, is increasing against a backdrop of declining smoking rates. E-cigarettes contain fewer toxicants than cigarettes, but their appearance and mode of use has the potential to satisfy the habitual aspects of smoking. To date, we know little about lay perceptions of the safety of using e-cigarettes in pregnancy. METHODS: We conducted a thematic discourse analysis of 13 online discussion forum threads that discussed e-cigarette use during pregnancy...
October 20, 2016: Women's Health Issues: Official Publication of the Jacobs Institute of Women's Health
Tara C Jatlaoui, Halley E M Riley, Kathryn M Curtis
OBJECTIVE: To determine the association between use of intrauterine devices (IUDs) by young women and risk of adverse outcomes. METHODS: We searched Pubmed, CINAHL, Embase, Popline and the Cochrane Library for articles from inception of database through December 2015. For outcomes specific to IUD use (IUD expulsion and perforation), we examined effect measures for IUD users generally aged 25 years or younger compared with older IUD users. For outcomes of pregnancy, infection, pelvic inflammatory disease (PID), and heavy bleeding or anemia, we examined young IUD users compared with young users of other contraceptive methods or no method...
October 19, 2016: Contraception
Monique Jenkins, Carol F Roye, Keville Frederickson
PURPOSE: The aim of this study was to gain a deeper understanding of the lived experiences of underserved minority sexually active teenaged girls' successful avoidance of unwanted pregnancy. DESIGN AND METHOD: Merleau-Ponty's methodology and van Manen's method of doing phenomenological research guided and facilitated the process of the study. 7 participants were eligible and all of them were interviewed for this study. RESULTS: Six main themes were identified: sense of emotional safety; sense of being free from a potential pregnancy; feeling supported by family and friends; connections built on trust and communication; regard for self through self-esteem and self-confidence; and sense of having life goals...
October 19, 2016: Journal of Pediatric Nursing
Mieke L G Ten Eikelder, Kelly Mast, Annemarie van der Velden, Kitty W M Bloemenkamp, Ben W Mol
Importance: Induction of labor is a widely used obstetric intervention, occurring in one in four pregnancies. When the cervix is unfavorable, still many different induction methods are used. Objective: We compared Foley catheter alone to different misoprostol dosages and administration routes, and the combination of Foley catheter with misoprostol. Evidence acquisition: We reviewed the literature on the best induction method regarding their safety and effectiveness, using the outcome measures hyperstimulation, fetal distress, neonatal morbidity and mortality as well as cesarean delivery, vaginal instrumental delivery, and maternal morbidity...
October 2016: Obstetrical & Gynecological Survey
Uma Mahadevan, Ryan A McConnell, Christina Chambers
The management of the pregnant patient with inflammatory bowel disease (IBD) is complicated by multiple providers, misinformation and a disease entity that, particularly when active, can adversely affect pregnancy outcomes. This paper seeks to frame the debate on medication safety in pregnancy and lactation using the Food and Drug Administration's new Pregnancy and Lactation Labeling Rule (PLLR) and the most up to date safety information to discuss the risks and benefits of using each class of IBD medication...
October 18, 2016: Gastroenterology
Maïlys De Sousa Mendes, Gabrielle Lui, Yi Zheng, Claire Pressiat, Deborah Hirt, Elodie Valade, Naïm Bouazza, Frantz Foissac, Stephane Blanche, Jean-Marc Treluyer, Saik Urien, Sihem Benaboud
BACKGROUND: Pregnant women and their fetuses are exposed to numerous drugs; however, they are orphan populations with respect to the safety and efficacy of drugs. Therefore, the prediction of maternal and fetal drug exposure prior to administration would be highly useful. METHODS: A physiologically-based pharmacokinetic (PBPK) model for nevirapine, which is metabolized by the cytochrome P450 (CYP) 3A4, 2B6 and 2D6 pathways, was developed to predict maternal and fetal pharmacokinetics (PK)...
October 21, 2016: Clinical Pharmacokinetics
P Li, H X Chen, Y H Huang, E L Zhi, R H Tian, H Zhao, F Yang, H F Sun, Y H Gong, Z J Zhu, Y Hong, Y D Liu, S J Xia, Z Li
Objective: To evaluate the efficacy and safety of microsurgical crossover vasovasostomy in treating complicated obstructive azoospermia. Methods: The data of 14 patients with complicated obstructive azoospermia treated with microsurgical crossover vasovasostomy were reviewed from October 2012 to March 2016.Ten of them underwent microsurgical crossover vasovasostomy. Intraoperative exploration revealed that 2 patients had vas deferens injury and contralateral testicular atrophy or epididymal obstruction due to previous hernia repair; 7 patients had obstruction of intracorporeal vas deferens on one side and epididymal obstruction on the other side; the other 1 patient had unilateral vasal obstruction with contralateral epididymal obstruction...
September 27, 2016: Zhonghua Yi Xue za Zhi [Chinese medical journal]
V R Badhwar, S Ganapathy, P P Prabhudesai, N K Tulara, A Y Varaiya, D Vyas
In community and family practice, infections are a common OPD presentation. In the management of common bacterial infections seen in community especially RTI, UTI, SSTI; cefuroxime a second generation cephalosporin with a broad spectrum of activity can be used for empirical treatment. To know current place of cefuroxime in the management of infections, physicians, surgeons, microbiologist, chest physician, gynecologist and pediatrician came together to discuss and debate their experience with cefuroxime and its place in today's world...
July 2016: Journal of the Association of Physicians of India
Riki Bergel, Eran Hadar, Yoel Toledano, Moshe Hod
Gestational diabetes mellitus (GDM) is one of the most common morbidities complicating pregnancy, with short- and long-term consequences to the mothers, fetuses, and newborns. Management and treatment are aimed to achieve best possible glycemic control, while avoiding hypoglycemia and ensuring maternal and fetal safety. It involves behavioral modifications, nutrition and medications, if needed; concurrent with maternal and fetal surveillance for possible adverse outcomes. This review aims to elaborate on the pharmacological options for GDM therapy...
November 2016: Current Diabetes Reports
Tonghua Wu, Biao Yin, Yuanchang Zhu, Guangui Li, Lijun Ye, Chunmei Chen, Yong Zeng, Desheng Liang
BACKGROUND: Spontaneous abortion (SA) is the most common complication of pregnancy, and chromosome aberrations are the principal cause of the first trimester abortuses in natural conception (NC) The increasing use of assisted reproductive technology (ART) has raised concern about chromosome abnormalities in ART-initiated pregnancies. Up to date, the literature on the risk of aneuploidy in failed pregnancies among various ART factors remain limited and inconclusive. This study aimed to explore the genetic etiology of pregnancy loss conceived from varying ART procedures...
2016: Molecular Cytogenetics
Jan Bonhoeffer, Sonali Kochhar, Steven Hirschfeld, Paul T Heath, Christine E Jones, Jorgen Bauwens, Ángel Honrado, Ulrich Heininger, Flor M Muñoz, Linda Eckert, Mark Steinhoff, Steven Black, Michael Padula, Miriam Sturkenboom, Jim Buttery, Robert Pless, Patrick Zuber
Immunization in pregnancy provides a promising contribution to globally reducing neonatal and under-five childhood mortality and morbidity. Thorough assessment of benefits and risks for the primarily healthy pregnant women and their unborn babies is required. The GAIA project was formed in response to the call of the World Health Organization for a globally concerted approach to actively monitor the safety of vaccines and immunization in pregnancy programs. GAIA aims to improve the quality of outcome data from clinical vaccine trials in pregnant women with a specific focus on the needs and requirements for safety monitoring in LMIC...
October 14, 2016: Vaccine
Chen-Yu Wang, Yu-Ju Lai, Kwei-Shuai Hwang, Chi-Huang Chen, Mu-Hsien Yu, Huei-Tsung Chen, Her-Young Su
OBJECTIVE: Neutropenia developed after continuous intravenous infusion of ritodrine hydrochloride (Yutopar) for preterm uterine contractions in a twin pregnancy. We successfully returned the low neutrophil count to the normal range after discontinuation of infusion of ritodrine and treatment with granulocyte colony stimulating factor (G-CSF). CASE REPORT: A 34-year-old woman with twin pregnancy was treated with ritodrine for preterm uterine contractions at 27 weeks and 6 days gestation...
October 2016: Taiwanese Journal of Obstetrics & Gynecology
Xiang Kong, Yan Kong, Fangyuan Zhang, Tingting Wang, Jin Yan
BACKGROUND: Intrahepatic cholestasis of pregnancy (ICP) is a specific pregnancy-related disorder without standard medical therapies. Ursodeoxycholic acid (UDCA) is the most used medicine, but the efficacy and safety of UDCA remain uncertain. Several meta-analyses had been made to assess the effects of UDCA in ICP. However, the samples were not large enough to convince obstetricians to use UDCA. We conducted a meta-analysis to evaluate the effects and safety of UDCA in patients with ICP, which included only randomized controlled trials (RCTs)...
October 2016: Medicine (Baltimore)
Marc D Cohen, Edward Keystone
Rituximab is a chimeric monoclonal antibody directed at the CD20 molecule on the surfaces of some but not all B cells. It depletes almost all peripheral B cells, but other niches of B cells are variably depleted, including synovium. Its mechanism of action in rheumatoid arthritis (RA) is only partially understood. Rituximab was efficacious in clinical trials of patients with RA, including those who are methotrexate naïve, those with an incomplete response to methotrexate, and those with an incomplete response to tumor necrosis factor inhibitors...
December 2015: Rheumatol Ther
Hatice Kansu-Celik, Ozlem Gun-Eryılmaz, Nasuh Utku Dogan, Seval Haktankaçmaz, Mehmet Cinar, Saynur Sarici Yilmaz, Cavidan Gülerman
BACKGROUND: We aimed to evaluate the efficacy and safety of dinoprostone for cervical ripening and labor induction in patients with term oligohydramnios and Bishop score ≤ 5. METHODS: This was a prospective case-control study, which included 104 consecutive women with a Bishop score≤5. Participants were divided into two groups. Women with term isolated oligohydramnios and Bishop score≤5 underwent induction of labor with a vaginal insert containing 10-mg timed-release dinoprostone (prostaglandin E2; Group A, n=40)...
October 10, 2016: Journal of the Chinese Medical Association: JCMA
Julie-Anne Quinn, Flor M Munoz, Bernard Gonik, Lourdes Frau, Clare Cutland, Tamala Mallett-Moore, Aimee Kissou, Frederick Wittke, Manoj Das, Tony Nunes, Savia Pye, Wendy Watson, Ana-Maria Alguacil Ramos, Jose F Cordero, Wan-Ting Huang, Sonali Kocchar, Jim Buttery
Preterm birth is commonly defined as any birth before 37 weeks completed weeks of gestation. An estimated 15 million infants are born preterm globally, disproportionately affecting low and middle income countries (LMIC). It contributes directly to estimated one million neonatal deaths annually and is a significant contributor to childhood morbidity. However, in many clinical settings, the information available to calculate completed weeks of gestation varies widely. Accurate dating of the last menstrual period (LMP), as well as access to clinical and ultrasonographic evaluation are important components of gestational age assessment antenatally...
October 13, 2016: Vaccine
Camille Clare, Mary-Beatrice Squire, Karem Alvarez, Julia Meisler, Candice Fraser
OBJECTIVE: The United States has the highest rate of adolescent pregnancy of the industrialized nations. Previously reported patient barriers to the use of contraception included an ambivalence about pregnancy; method side effects; difficulty using methods; lack of satisfaction with methods; concerns about safety; expense; and a lack of knowledge about long-acting reversible contraception (LARC). This survey aims to determine if there are additional barriers to contraception use and adherence among an ethnically diverse urban population...
October 15, 2016: International Journal of Adolescent Medicine and Health
Amit Odelia, Joffe Erel, Perry Chava, Herishanu Yair, Sarid Nadav, Lishner Michael, Avivi Irit
INTRODUCTION: Due to the rarity of lymphoma during pregnancy, management guidelines are based upon evidence from retrospective studies and case reports. Here, we review the major dilemmas in the field and examine the approach of hemato-oncologists in Israel to the management of lymphoma in pregnancy. METHODOLOGY: We performed a literature search on the PubMed database using keywords for all papers on the subject from 1990-2014. The papers were reviewed by an expert panel who devised a questionnaire covering the main dilemmas...
October 14, 2016: International Journal of Clinical Oncology
Chandni Prakash, Susan Hatters-Friedman, Charmian Moller-Olsen, Abigail North
INTRODUCTION: Pregnancy is a vulnerable period for recurrence of bipolar disorder. Discontinuation of mood stabilisers during pregnancy and the postpartum period can significantly increase the risk of recurrence of bipolar disorder. Lamotrigine is an anti-epileptic drug that has been approved for the maintenance treatment of bipolar disorder. Epilepsy literature has indicated that lamotrigine has a reassuring safety profile in pregnancy but there is little information on its effectiveness and safety in pregnant women with mental disorders...
August 15, 2016: Psychopharmacology Bulletin
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