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Consent approaches for research into intrapartum complications: a systematic review
  1. S A Nasir1,
  2. D Patel1,
  3. A Elati2,
  4. A Weeks2,
  5. G Vernon2
  1. 1University of Liverpool, Liverpool, UK
  2. 2Liverpool Women's Hospital, Liverpool, UK

Abstract

Objective To review the consent approaches that researchers have used for trials conducted between the 1950s and 2000s concerning intrapartum complications.

Method The Cochrane Library database was used to access intrapartum trials related to the management of complications during labour. Studies excluded from analysis were abstracts, non-English, non-RCTs, prophylactic studies, repeat publications of a single RCT, unpublished trials and those investigating non-obstetric complications.

Results 138 studies met the inclusion criteria. Seeking consent at the time of complication was the most common approach. It constitutes 58% of the first stage and 41% of the second stage labour trials. In contrast, obtaining consent from total population during early labour was the most common approach in third stage trials (26%). Overall, researchers did not report taking consent in 20% of the first stage trials, 48% in the second stage and 30% in the third stage of labour trials. Between 1950s and 1970s, 100% of studies had no evidence of consent recorded. Consent at the time of complication was the most popular approach in the 1990s (66%). Throughout 2000–2010, 20% of researchers sought consent from the total population during early labour and 18% provided antenatal information and then obtained consent at the time of complication.

Conclusion Over the last three decades, researchers have been getting better at seeking consent by using a variety of different consent approaches. Labouring women should be considered as a special group of subjects, the physical and psychological effects of labour make this group vulnerable.

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