Pregnant womens' concerns when invited to a randomized trial: a qualitative case control study

BMC Pregnancy and Childbirth
Katrien Oude RengerinkBen Willem Mol

Abstract

Pregnant women were excluded from clinical trials until the 1990s, but the Food and Drug Administration nowadays allows--and even encourages--responsible inclusion of pregnant women in trials with adequate safety monitoring. Still, randomized trials in pregnant women face specific enrolment challenges. Previous studies have focused on barriers to trial participation in studies that had failed to recruit sufficient participants. Our aim was to identify barriers and motivators for participation in a range of clinical trials being conducted in the Netherlands, regardless of recruitment performance. We performed a qualitative case control study in women who had been asked in 2010 to participate in one of eight clinical trials during pregnancy or shortly after giving birth. Both participants and non-participants of these clinical trials were invited for a face-to-face interview that addressed motives for participation and non-participation. We started the interview in an open fashion, asking the women for their main motive for participation or non-participation. When no new information emerged in this open part, we continued with a semi-structured interview, guided by a topic list. Transcripts of the interviews were analysed using a...Continue Reading

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Citations

Apr 21, 2016·Thrombosis Research·Marc A RodgerUNKNOWN PROSPER Investigators: Tim Ramsay, Dean Fergusson, Anne McLeod, Wee Shian Chan, Rshmi Khurana, Kara Narenberg, Haim Abenhaim
Mar 13, 2016·Ultrasound in Obstetrics & Gynecology : the Official Journal of the International Society of Ultrasound in Obstetrics and Gynecology·M SheppardUNKNOWN EVERREST Consortium
Oct 18, 2018·International Urogynecology Journal·Mabel Leng Sim LieChristopher Harding
Mar 7, 2019·International Journal of Environmental Research and Public Health·Daniela CalinaAntonis Makrigiannakis
Feb 13, 2019·BMC Pregnancy and Childbirth·Indira S E van der ZandeJohannes J M van Delden
May 17, 2017·BMC Medical Ethics·Indira S E van der ZandeJohannes J M van Delden
May 29, 2020·AIDS Research and Therapy·Kristen SullivanAnne Drapkin Lyerly
Oct 8, 2020·The Cochrane Database of Systematic Reviews·Catherine HoughtonLinda M Biesty
Nov 3, 2020·Transactions of the Royal Society of Tropical Medicine and Hygiene·Joseph OsarfoHarry K Tagbor

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