Literature DB >> 25425718

Recruitment and retention of pregnant women into clinical research trials: an overview of challenges, facilitators, and best practices.

Paula M Frew1, Diane S Saint-Victor2, Margaret Brewinski Isaacs3, Sonnie Kim4, Geeta K Swamy5, Jeanne S Sheffield6, Kathryn M Edwards7, Tonya Villafana8, Ouda Kamagate2, Kevin Ault9.   

Abstract

Pregnant women are a vulnerable group who are needed in clinical research studies to advance prevention and treatment options for this population. Yet, pregnant women remain underrepresented in clinical research. Through the lens of the socioecological model, we highlight reported barriers and facilitators to recruitment and retention of pregnant women in studies that sought their participation. We trace historical, policy-based reasons for the exclusion of pregnant women in clinical studies to present-day rationale for inclusion of this group. The findings highlight why it has been difficult to recruit and retain this population over time. A body of literature suggests that integrative sampling and recruitment methods that leverage the influence and reach of prenatal providers will overcome recruitment challenges. We argue that these strategies, in combination with building strong engagement with existing community-based organizations, will enable teams to more effectively promote and retain pregnant women in future longitudinal cohort studies.
© The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Entities:  

Keywords:  clinical research trials; pregnant women; recruitment; retention; vulnerable populations

Mesh:

Year:  2014        PMID: 25425718      PMCID: PMC4303058          DOI: 10.1093/cid/ciu726

Source DB:  PubMed          Journal:  Clin Infect Dis        ISSN: 1058-4838            Impact factor:   9.079


  77 in total

Review 1.  Translating social ecological theory into guidelines for community health promotion.

Authors:  D Stokols
Journal:  Am J Health Promot       Date:  1996 Mar-Apr

2.  Socioecological influences on community involvement in HIV vaccine research.

Authors:  Paula M Frew; Matthew Archibald; Brooke Hixson; Carlos del Rio
Journal:  Vaccine       Date:  2011-06-29       Impact factor: 3.641

3.  Healthy Moms, a randomized trial to promote and evaluate weight maintenance among obese pregnant women: study design and rationale.

Authors:  Kimberly K Vesco; Njeri Karanja; Janet C King; Matthew W Gillman; Nancy Perrin; Cindy McEvoy; Cara Eckhardt; K Sabina Smith; Victor J Stevens
Journal:  Contemp Clin Trials       Date:  2012-03-20       Impact factor: 2.226

4.  Patient participation in research in the managed care environment: key perceptions of members in an HMO.

Authors:  S Purdy; J A Finkelstein; R Fletcher; C Christiansen; T S Inui
Journal:  J Gen Intern Med       Date:  2000-07       Impact factor: 5.128

5.  Does behavioral intervention in pregnancy reduce postpartum weight retention? Twelve-month outcomes of the Fit for Delivery randomized trial.

Authors:  Suzanne Phelan; Maureen G Phipps; Barbara Abrams; Francine Darroch; Kelsey Grantham; Andrew Schaffner; Rena R Wing
Journal:  Am J Clin Nutr       Date:  2013-11-27       Impact factor: 7.045

6.  Teratogenicity of recently introduced medications in human pregnancy.

Authors:  W Y Lo; J M Friedman
Journal:  Obstet Gynecol       Date:  2002-09       Impact factor: 7.661

7.  Reasons for participation and non-participation in a randomized controlled trial: postal questionnaire surveys of women eligible for TOMBOLA (Trial Of Management of Borderline and Other Low-Grade Abnormal smears).

Authors:  L Sharp; S C Cotton; L Alexander; E Williams; N M Gray; J M Reid
Journal:  Clin Trials       Date:  2006       Impact factor: 2.486

8.  Recruiting and retaining postpartum women from areas of social disadvantage in a weight-loss trial--an assessment of strategies employed in the WeighWell feasibility study.

Authors:  Maureen Macleod; Angela M Craigie; Karen L Barton; Shaun Treweek; Annie S Anderson
Journal:  Matern Child Nutr       Date:  2012-01-29       Impact factor: 3.092

9.  Recruitment and retention of pregnant women for a behavioral intervention: lessons from the maternal adiposity, metabolism, and stress (MAMAS) study.

Authors:  Kimberly Coleman-Phox; Barbara A Laraia; Nancy Adler; Cassandra Vieten; Melanie Thomas; Elissa Epel
Journal:  Prev Chronic Dis       Date:  2013       Impact factor: 2.830

10.  Effectiveness of personalised, home-based nutritional counselling on infant feeding practices, morbidity and nutritional outcomes among infants in Nairobi slums: study protocol for a cluster randomised controlled trial.

Authors:  Elizabeth W Kimani-Murage; Catherine Kyobutungi; Alex C Ezeh; Frederick Wekesah; Milka Wanjohi; Peterrock Muriuki; Rachel N Musoke; Shane A Norris; Paula Griffiths; Nyovani J Madise
Journal:  Trials       Date:  2013-12-27       Impact factor: 2.279

View more
  41 in total

1.  A systematic review of components of community-based organisation engagement.

Authors:  Oluwamuyiwa Winifred Adebayo; John P Salerno; Valerie Francillon; Jessica R Williams
Journal:  Health Soc Care Community       Date:  2018-01-04

2.  Lessons Learned From a Feasibility Study Delivered in 2 WIC Sites to Promote Physical Activity Among Pregnant Latinas.

Authors:  Sandra H Soto; Stephanie Sanz; Kathleen M Merchant; Jeanne F Nichols; Elva M Arredondo
Journal:  J Nutr Educ Behav       Date:  2018-06-25       Impact factor: 3.045

3.  Overcoming Barriers and Identifying Opportunities for Developing Maternal Immunizations: Recommendations From the National Vaccine Advisory Committee.

Authors: 
Journal:  Public Health Rep       Date:  2017-04-05       Impact factor: 2.792

4.  Recruiting pregnant smokers from Text4baby for a randomized controlled trial of Quit4baby.

Authors:  Leah Leavitt; Lorien Abroms; Pamela Johnson; Jennifer Schindler-Ruwisch; Jessica Bushar; Indira Singh; Sean D Cleary; Whitney McInvale; Monique Turner
Journal:  Transl Behav Med       Date:  2017-06       Impact factor: 3.046

Review 5.  A Systematic Review of Technology-Based Prevention and Treatment Interventions for Perinatal Depression and Anxiety in Latina and African American Women.

Authors:  Sandraluz Lara-Cinisomo; Andrea Ramirez Olarte; Maria Rosales; Alinne Z Barrera
Journal:  Matern Child Health J       Date:  2021-01-03

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.  Group Prenatal Care Attendance and Women's Characteristics Associated with Low Attendance: Results from Centering and Racial Disparities (CRADLE Study).

Authors:  Ellen Francis; Mary Beth Johnstone; Sarah Convington-Kolb; Brian Witrick; Sarah F Griffin; Xiaoqian Sun; Amy Crockett; Liwei Chen
Journal:  Matern Child Health J       Date:  2019-10

Review 8.  Recruitment and retention of pregnant women in prospective birth cohort studies: A scoping review and content analysis of the literature.

Authors:  Ellen Goldstein; Ludmila N Bakhireva; Kendra Nervik; Shelbey Hagen; Alyssa Turnquist; Aleksandra E Zgierska; Lidia Enriquez Marquez; Ryan McDonald; Jamie Lo; Christina Chambers
Journal:  Neurotoxicol Teratol       Date:  2021-03-22       Impact factor: 3.763

Review 9.  Effectiveness of patient decision aids in women considering psychotropic medication use during pregnancy: a literature review.

Authors:  Lucy C Broughton; Natalie J Medlicott; Alesha J Smith
Journal:  Arch Womens Ment Health       Date:  2021-03-09       Impact factor: 3.633

10.  The Bumps and BaBies Longitudinal Study (BaBBLeS): a multi-site cohort study of first-time mothers to evaluate the effectiveness of the Baby Buddy app.

Authors:  Toity Deave; Samuel Ginja; Trudy Goodenough; Elizabeth Bailey; Lukasz Piwek; Jane Coad; Crispin Day; Samantha Nightingale; Sally Kendall; Raghu Lingam
Journal:  Mhealth       Date:  2019-09-25
View more

北京卡尤迪生物科技股份有限公司 © 2022-2023.