Literature DB >> 21819233

Clinical research enrolling pregnant women: a workshop summary.

Mary A Foulkes1, Christine Grady, Catherine Y Spong, Angela Bates, Janine A Clayton.   

Abstract

Clinical research investigates mechanisms of human disease, interventions, or new technologies, but pregnant women are often excluded from clinical studies. Few studies, beyond research on pregnancy, are designed to address questions relevant to pregnant women. A recent National Institutes of Health workshop considered the barriers and opportunities in conducting clinical research studies enrolling pregnant women.

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Mesh：

Year:  2011        PMID： 21819233      PMCID： PMC3186443          DOI： 10.1089/jwh.2011.3118

Source DB:  PubMed          Journal:  J Womens Health (Larchmt)        ISSN： 1540-9996            Impact factor:   2.681


  13 in total

1.  Prescription of drugs during pregnancy in France.

Authors:  I Lacroix; C Damase-Michel; M Lapeyre-Mestre; J L Montastruc
Journal:  Lancet       Date:  2000-11-18       Impact factor: 79.321

2.  Pregnant women deserve better.

Authors:  Françoise Baylis
Journal:  Nature       Date:  2010-06-10       Impact factor: 49.962

3.  Enrolling pregnant women in research--lessons from the H1N1 influenza pandemic.

Authors:  Sara F Goldkind; Leyla Sahin; Beverly Gallauresi
Journal:  N Engl J Med       Date:  2010-06-17       Impact factor: 91.245

4.  The treatment of women suffering from depression who are either pregnant or breastfeeding.

Authors:  Kimberly A Yonkers
Journal:  Am J Psychiatry       Date:  2007-10       Impact factor: 18.112

5.  Drug safety in pregnant women and their babies: ignorance not bliss.

Authors:  C D Chambers; J E Polifka; J M Friedman
Journal:  Clin Pharmacol Ther       Date:  2007-12-12       Impact factor: 6.875

6.  Enrolling pregnant women in biomedical research.

Authors:  Ruth Macklin
Journal:  Lancet       Date:  2010-02-20       Impact factor: 79.321

7.  Neonatal abstinence syndrome after methadone or buprenorphine exposure.

Authors:  Hendrée E Jones; Karol Kaltenbach; Sarah H Heil; Susan M Stine; Mara G Coyle; Amelia M Arria; Kevin E O'Grady; Peter Selby; Peter R Martin; Gabriele Fischer
Journal:  N Engl J Med       Date:  2010-12-09       Impact factor: 91.245

8.  The second wave: Toward responsible inclusion of pregnant women in research.

Authors:  Anne Drapkin Lyerly; Margaret Olivia Little; Ruth Faden
Journal:  Int J Fem Approaches Bioeth       Date:  2008

9.  Pharmacokinetics of sulfadoxine and pyrimethamine in intermittent preventive treatment of malaria in pregnancy.

Authors:  M M Nyunt; I Adam; K Kayentao; J van Dijk; P Thuma; K Mauff; F Little; Y Cassam; E Guirou; B Traore; O Doumbo; D Sullivan; P Smith; K I Barnes
Journal:  Clin Pharmacol Ther       Date:  2009-09-23       Impact factor: 6.875

10.  Perinatal outcomes of a pregnancy complicated by cancer, including neonatal follow-up after in utero exposure to chemotherapy: results of an international registry.

Authors:  Elyce Cardonick; Aniqa Usmani; Sadia Ghaffar
Journal:  Am J Clin Oncol       Date:  2010-06       Impact factor: 2.339
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  19 in total

1.  The ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials.

Authors:  Mary Jane Welch; Rachel Lally; Jennifer E Miller; Stephanie Pittman; Lynda Brodsky; Arthur L Caplan; Gina Uhlenbrauck; Darcy M Louzao; James H Fischer; Benjamin Wilfond
Journal:  Clin Trials       Date:  2015-09-15       Impact factor: 2.486

2.  Reasons Why Pregnant Women Participate in Ultrasound Research Involving Transvaginal Scans.

Authors:  Barbara T Meagher; Marissa R Campos; Patrick Thornton; Carrie Klima; Tara A Peters; Josefin Hallberg; Emma Ulfhager; William D O'Brien; Barbara L McFarlin
Journal:  J Ultrasound Med       Date:  2020-02-19       Impact factor: 2.153

3.  Working Together to Address Women's Health in Research and Drug Development: Summary of the 2017 Women's Health Congress Preconference Symposium.

Authors:  Irwin M Feuerstein; Marjorie R Jenkins; Susan G Kornstein; Michael S Lauer; Pamela E Scott; Tonse N K Raju; Tamara Johnson; Stephanie Devaney; Milena Lolic; Marsha Henderson; Janine Austin Clayton
Journal:  J Womens Health (Larchmt)       Date:  2018-10       Impact factor: 2.681

4.  Physiologically Based Pharmacokinetic Modeling of Renally Cleared Drugs in Pregnant Women.

Authors:  André Dallmann; Ibrahim Ince; Juri Solodenko; Michaela Meyer; Stefan Willmann; Thomas Eissing; Georg Hempel
Journal:  Clin Pharmacokinet       Date:  2017-12       Impact factor: 6.447

Review 5.  The REVAMP trial to evaluate HIV resistance testing in sub-Saharan Africa: a case study in clinical trial design in resource limited settings to optimize effectiveness and cost effectiveness estimates.

Authors:  Mark J Siedner; Mwebesa B Bwana; Mahomed-Yunus S Moosa; Michelle Paul; Selvan Pillay; Suzanne McCluskey; Isaac Aturinda; Kevin Ard; Winnie Muyindike; Pravikrishnen Moodley; Jaysingh Brijkumar; Tamlyn Rautenberg; Gavin George; Brent Johnson; Rajesh T Gandhi; Henry Sunpath; Vincent C Marconi
Journal:  HIV Clin Trials       Date:  2017-07-18

6.  Electronic Informed Consent to Facilitate Recruitment of Pregnant Women Into Research.

Authors:  Julia C Phillippi; Jennifer K Doersam; Jeremy L Neal; Christianne L Roumie
Journal:  J Obstet Gynecol Neonatal Nurs       Date:  2018-07

7.  Advancing HIV research with pregnant women: navigating challenges and opportunities.

Authors:  Carleigh B Krubiner; Ruth R Faden; R Jean Cadigan; Sappho Z Gilbert; Leslie M Henry; Margaret O Little; Anna C Mastroianni; Emily E Namey; Kristen A Sullivan; Anne D Lyerly
Journal:  AIDS       Date:  2016-09-24       Impact factor: 4.177

8.  Enrolling pregnant women: issues in clinical research.

Authors:  Mary C Blehar; Catherine Spong; Christine Grady; Sara F Goldkind; Leyla Sahin; Janine A Clayton
Journal:  Womens Health Issues       Date:  2013-01

9.  Automated classification of eligibility criteria in clinical trials to facilitate patient-trial matching for specific patient populations.

Authors:  Kevin Zhang; Dina Demner-Fushman
Journal:  J Am Med Inform Assoc       Date:  2017-07-01       Impact factor: 4.497

10.  Screening for Pregnancy Status in a Population-Based Sample: Characteristics Associated with Item Nonresponse.

Authors:  Suzanne C Hughes; Carol J Hogue; Melissa A Clark; Jessica E Graber; Elaine D Eaker; Amy H Herring
Journal:  Matern Child Health J       Date:  2019-03
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