Literature DB >> 27720094

Optimizing Participation of Pregnant Women in Clinical Trials: Factors Influencing Decisions About Participation in Medication and Vaccine Trials.

Sophie Palmer1, Jessica Pudwell2, Graeme N Smith3, Robert L Reid4.   

Abstract

OBJECTIVE: To obtain information on women's attitudes and opinions about participation in vaccine and medication trials during pregnancy.
METHODS: A quantitative, cross-sectional survey was administered to 110 consenting women over a four-week period in the waiting room of an ambulatory obstetrics and gynaecology clinic in Ontario.
RESULTS: The final response rate was 74.8%, with the majority of participants agreeing with statements about the importance of obtaining safety data about products in pregnancy and the importance of a woman having the ability to choose whether to participate in such research. Of all participants, 16.3% indicated they would consider participating in vaccine research during pregnancy and 20.0% would consider participating in medication research during pregnancy. Factors relating to maternal or fetal/child health were the most frequently cited factors influencing willingness to participate, with lack of trust in researchers and pharmaceutical companies as factors that would discourage participation.
CONCLUSION: A minority of pregnant women were willing to consider participating in medication or vaccine research during pregnancy. Optimizing participation requires providing women (and if appropriate, their partners) with detailed, multidisciplinary education about the maternal and fetal benefits and risks of such trials. Education about the principles of research ethics, including the limits of involvement of pharmaceutical companies, would be beneficial.
Copyright © 2016 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.

Entities:  

Keywords:  Women's health; drug therapy; ethics; pregnancy; research; vaccines

Mesh:

Year:  2016        PMID: 27720094     DOI: 10.1016/j.jogc.2016.04.100

Source DB:  PubMed          Journal:  J Obstet Gynaecol Can        ISSN: 1701-2163


  5 in total

1.  Pregnant women's attitudes toward Zika virus vaccine trial participation.

Authors:  Ilona Telefus Goldfarb; Elana Jaffe; Kaitlyn James; Anne Drapkin Lyerly
Journal:  Vaccine       Date:  2018-09-27       Impact factor: 3.641

2.  Health Communication and Decision Making about Vaccine Clinical Trials during a Pandemic.

Authors:  Aisha T Langford
Journal:  J Health Commun       Date:  2020-10-02

3.  Effects of oral probiotic supplements on vaginal microbiota during pregnancy: a randomised, double-blind, placebo-controlled trial with microbiome analysis.

Authors:  S Husain; J Allotey; Z Drymoussi; M Wilks; B M Fernandez-Felix; A Whiley; J Dodds; S Thangaratinam; C McCourt; E M Prosdocimi; W G Wade; B M de Tejada; J Zamora; K Khan; M Millar
Journal:  BJOG       Date:  2019-04-01       Impact factor: 6.531

4.  Maternal vaccines during the Covid-19 pandemic:A qualitative interview study with UK pregnant women.

Authors:  Emma Anderson; Amberly Brigden; Anna Davies; Emily Shepherd; Jenny Ingram
Journal:  Midwifery       Date:  2021-06-11       Impact factor: 2.372

5.  Pregnant women's perceptions of risks and benefits when considering participation in vaccine trials.

Authors:  Elana Jaffe; Anne Drapkin Lyerly; Ilona Telefus Goldfarb
Journal:  Vaccine       Date:  2020-09-04       Impact factor: 3.641

  5 in total

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