A CLINICAL CARE PATHWAY FOR OBESE PREGNANT WOMEN: A PRAGMATIC PILOT CLUSTER RANDOMIZED CONTROLLED TRIAL

Objectives Obese women are at increased risks for various complications, and clinical management involves challenges. We conducted a pragmatic pilot cluster randomized controlled trial (RCT) to determine the feasibility of implementing and testing a clinical carepath for obese pregnant women versus standard care. Methods We randomly allocated clinics to the carepath or standard care. Eligible women had a pre-pregnancy body mass index of >30kg/m2 and a viable singleton <20 weeks. Our primary outcomes were the feasibility of conducting a full-scale cluster RCT (>80%: clinic randomization, carepath use, and follow-up) and of the intervention (>80%: compliance, and clinicians would recommend it to a colleague). We calculated risk ratios (RR) and 95% confidence intervals (95% CI). Results Eight approached clinics agreed to participate and were randomized. Half of the intervention clinics used the carepath (<80% uptake of eligible women). High follow-up (99.5%) was achieved, in 188 of 189 women. The carepath was feasible for numerous guideline-directed screening recommendations, but less so for counselling topics. All clinicians (primarily midwives) who used the carepath in the majority of women reported they would recommend it to a colleague. The intervention group had significantly higher overall adherence to the guideline recommendations compared to control (RR 1.71, 95% CI 1.57-1.87). 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 obstetrician- and midwifery-led clinics, but may be feasible in midwifery-led clinics.