Is a randomised controlled trial of a maternity care intervention for pregnant adolescents possible? An Australian feasibility study

Abstract

Background: The way in which maternity care is provided affects perinatal outcomes for pregnant adolescents; including the likelihood of preterm birth. The study purpose was to assess the feasibility of recruiting pregnant adolescents into a randomised controlled trial, in order to inform the design of an adequately powered trial which could test the effect of caseload midwifery on preterm birth for pregnant adolescents. Methods. We recruited pregnant adolescents into a feasibility study of a prospective, un-blinded, two-arm, randomised controlled trial of caseload midwifery compared to standard care. We recorded and analysed recruitment data in order to provide estimates to be used in the design of a larger study. Results: The proportion of women aged 15-17 years who were eligible for the study was 34% (n=10), however the proportion who agreed to be randomised was only 11% (n = 1). Barriers to recruitment were restrictive eligibility criteria, unwillingness of hospital staff to assist with recruitment, and unwillingness of pregnant adolescents to have their choice of maternity carer removed through randomisation. Conclusions: A randomised controlled trial of caseload midwifery care for pregnant adolescents would not be feasible in this setting without modifications to the research protocol. The recruitment plan should maximise opportunities for participation by increasing the upper age limit and enabling women to be recruited at a later gestation. Strategies to engage the support of hospital-employed staff are essential and would require substantial, and ongoing, work. A Zelen method of post-randomisation consent, monetary incentives and 'peer recruiters' could also be considered. © 2013 Allen et al.; licensee BioMed Central Ltd.