Lessons learned from a resident-led clinical trial in obstetrics

Clin Trials. 2013 Aug;10(4):612-6. doi: 10.1177/1740774513492045. Epub 2013 Jun 13.


Background: Completion of a randomised controlled trial is one way by which the resident research requirement can be met in Canadian obstetrics and gynaecology programmes. However, little is known about the specific challenges of performing clinical trials within the specialty, let alone as a resident project.

Purpose: A resident-led randomised controlled trial comparing two methods of labour induction at term was halted due to insufficient patient enrolment. A structured review of the study design and recruitment process was conducted to identify factors contributing to poor recruitment.

Methods: In addition to completing a literature review and internal review by the research team, we surveyed obstetricians and residents regarding recruitment efforts and barriers to participation. We solicited feedback on trial design and the expectations of clinicians with respect to participation in research studies.

Results: Eight obstetricians (67%) and 13 residents (93%) responded to the survey. All were able to identify eligible patients, though only 60% had invited one or more patients to participate during the recruitment period. Failure to consider trial participation and excessive clinical workload were the most commonly cited barriers for clinicians. Resistance to the test intervention was the major barrier to patient participation. Several residents cited a lack of personal incentive to recruit patients as a significant barrier.

Limitations: The research team was unable to contact patients directly, thus limiting the scope of our review to our internal methods and feedback from clinicians.

Conclusions: Poor recruitment in a resident-led clinical trial in obstetrics resulted from multiple coexisting factors. A structured review provided valuable insight for the research team. Academic clinicians and trainees in all specialties should be encouraged to share their experiences in the hope of improving the likelihood of success in future research endeavours.

Trial registration: ClinicalTrials.gov NCT00890630.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Canada
  • Early Termination of Clinical Trials*
  • Female
  • Humans
  • Internship and Residency
  • Labor, Induced / methods*
  • Medical Staff, Hospital*
  • Obstetrics*
  • Patient Selection*
  • Pregnancy
  • Research Design
  • Research Report
  • Surveys and Questionnaires

Associated data

  • ClinicalTrials.gov/NCT00890630