What we have learned about best practices for recruitment and retention in multicenter pregnancy studies.

For 30 years, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network has had significant impact on clinical practice in obstetrics. The MFMU Network has conducted 50 randomized clinical trials and observational studies designed to improve pregnancy outcomes for mothers and children. Each center has a designated clinical research nurse coordinator who coordinates the day-to-day operations of each trial and leads a research team that is responsible for recruitment and retention of participants. Some of the lessons learned by the nurse coordinators over the past 30 years are described with examples from recent studies. Best practices that we have amassed from our experience are also described.

Cervical ripening with foley balloon plus fixed versus incremental low-dose oxytocin: a randomized controlled trial.

OBJECTIVE: To evaluate cervical ripening with foley balloon combined with a fixed vs. incremental low-dose oxytocin infusion. METHODS: Women presenting for term labor induction were randomized to fixed low-dose or standard incremental low-dose oxytocin infusion following foley balloon placement. The primary outcome was time from foley balloon placement to delivery. RESULTS: Among 116 subjects, there was no difference in median time to delivery among subjects receiving fixed low-dose vs. standard incremental low-dose oxytocin during induction of labor with a foley balloon (23.7 vs. 19.2 hours). There were no differences between the two groups in median time to foley bulb extrusion, active labor and second stage of labor or incidence of uterine tachysystole, fetal heart rate abnormalities, mode of delivery or maternal hemorrhage. CONCLUSIONS: There is no difference in median time to delivery in women undergoing cervical ripening with a foley balloon combined with a fixed low-dose or standard incremental low-dose oxytocin.