BACKGROUND: Breast stimulation to augment labor has been used for centuries in tribal societies and by midwives. In recent years it has been shown to be effective in ripening the cervix, inducing labor, and as an alternative to oxytocin for the contraction stress test. This study compared the effectiveness of breast stimulation with oxytocin infusion in augmenting labor. METHODS:Women admitted to the labor ward were eligible for the study if they had inadequate labor with premature rupture of the membranes and met inclusion criteria. They were assigned to oxytocin augmentation or breast stimulation (manual or pump), and were switched to oxytocin in the event of method failure. Outcomes included time to delivery, intervention to delivery, proportion of spontaneous deliveries, and Apgar scores. One hundred participants were needed in each arm of the study to demonstrate a 2- to 3-hour difference in delivery time, with a power of 80 percent. RESULTS: Analysis was performed on 79 women, of whom 49 were in the breast stimulation group and 30 in the oxytocin group. Sixty-five percent of the participants failed breast stimulation and were switched to oxytocin infusion. Although augmentation start to delivery was shorter for the oxytocin group (p < 0.001), no differences in total labor time occurred between the groups. Nulliparas receiving breast stimulation had more spontaneous (relative risk 1.7, p = 0.04), and fewer instrumental deliveries than those receiving oxytocin (relative risk 0.2, p = 0.02). No significant differences in adverse fetal outcomes occurred between the study groups. CONCLUSIONS: The small number of participants and a variety of problems with the conduct of the study prevented the formulation of reliable conclusions from the results. However, the study provided important insights into the feasibility and problems of developing a high-quality randomized trial of augmentation by breast stimulation.
RCT Entities:
BACKGROUND: Breast stimulation to augment labor has been used for centuries in tribal societies and by midwives. In recent years it has been shown to be effective in ripening the cervix, inducing labor, and as an alternative to oxytocin for the contraction stress test. This study compared the effectiveness of breast stimulation with oxytocin infusion in augmenting labor. METHODS:Women admitted to the labor ward were eligible for the study if they had inadequate labor with premature rupture of the membranes and met inclusion criteria. They were assigned to oxytocin augmentation or breast stimulation (manual or pump), and were switched to oxytocin in the event of method failure. Outcomes included time to delivery, intervention to delivery, proportion of spontaneous deliveries, and Apgar scores. One hundred participants were needed in each arm of the study to demonstrate a 2- to 3-hour difference in delivery time, with a power of 80 percent. RESULTS: Analysis was performed on 79 women, of whom 49 were in the breast stimulation group and 30 in the oxytocin group. Sixty-five percent of the participants failed breast stimulation and were switched to oxytocin infusion. Although augmentation start to delivery was shorter for the oxytocin group (p < 0.001), no differences in total labor time occurred between the groups. Nulliparas receiving breast stimulation had more spontaneous (relative risk 1.7, p = 0.04), and fewer instrumental deliveries than those receiving oxytocin (relative risk 0.2, p = 0.02). No significant differences in adverse fetal outcomes occurred between the study groups. CONCLUSIONS: The small number of participants and a variety of problems with the conduct of the study prevented the formulation of reliable conclusions from the results. However, the study provided important insights into the feasibility and problems of developing a high-quality randomized trial of augmentation by breast stimulation.