A clinical carepath for obese pregnant women: a pragmatic pilot cluster randomized controlled trial

Objectives: Obese women are at increased risks for complications during pregnancy, birth, and in their infants. Although guidelines have been established for the clinical care of obese pregnant women, management is sometimes suboptimal. Our goal was to determine the feasibility of implementing and testing a clinical carepath for obese pregnant women compared to standard care, in a pilot cluster randomized controlled trial (RCT). Methods: A pragmatic pilot cluster RCT was conducted, randomly allocating eight clinics to the carepath or standard care for obese pregnant women. Women were eligible if they had a pre-pregnancy body mass index (BMI) of ≥30 kg/m2 and a viable singleton 80%: randomization of clinics, use in eligible women, and completeness of follow-up) and of the intervention (defined as >80%: compliance with each step in the carepath and recommendation of the carepath by clinicians to a colleague). Results: All eight approached clinics agreed to participate and were randomized. Half of the intervention clinics used the carepath, resulting in Conclusions: In this pragmatic pilot cluster RCT, a guideline-directed clinical carepath improved some aspects of care of obese pregnant women and was recommended by clinicians, particularly midwives. A cluster RCT may not be feasible in a mix of obstetric and midwifery clinics, but may be feasible in midwifery clinics.