When should women be recruited to intrapartum research projects? A retrospective review

Abstract

Objective: To review and describe the impact of varied recruitment processes in two intrapartum studies.

Design: Retrospective review of one prospective cohort study and one pilot randomized controlled trial.

Setting: Australian tertiary referral hospital.

Population: Women with term, cephalic singleton pregnancies.

Methods: Recruitment processes in one observational and one interventional study examining the management of occipitoposterior position in labor were reviewed. Data concerning recruitment and serial attrition for these studies were collected. The value of allowing consent in early labor in addition to consent in the antenatal period was assessed.

Main outcome measure: Relative proportions of women participating compared with the numbers approached and recruited.

Results: One in 48 women approached about the observational study agreed to participate and then had a fetus in occipitoposterior position. One in 33 women in the intervention study were eventually randomized. Women approached in early labor were more likely to agree to participate (77% vs. 58%; p < 0.0001), more likely to have an ultrasound scan during labor (40% vs. 15%; p < 0.0001) and more likely to be randomized to intervention (4% vs. 1.5%; p = 0.02).

Conclusion: Intrapartum research is associated with low rates of recruitment and these rates may be improved by asking women to provide informed consent during labor rather than the antenatal period. It is important to consider ways to facilitate randomized controlled trials involving women in labor to advance evidence-based care in this environment. This should include prospective research that seeks to define the best approach to patient recruitment.

Keywords: Intrapartum research; cohort study; ethics; informed consent; intervention study; occipitoposterior position; timing of consent.