Foley Catheter + Oxytocin vs. Oxytocin Alone for Labor Induction in PROM

Premature Rupture of Membranes (PROM), defined as the rupture of the amniotic sac before the onset of labor, affects a significant percentage of pregnancies and poses substantial risks including maternal infection (chorioamnionitis), fetal infection, and preterm birth. When PROM occurs, labor induction is often initiated to minimize these risks, particularly if the woman is not already in labor. However, selecting the most effective and safest induction method, especially when the cervix is unfavorable or "unripe," remains a clinical challenge. Current standard approaches frequently involve intravenous oxytocin to stimulate uterine contractions. While effective for many, oxytocin alone can sometimes lead to prolonged labor or require higher doses, increasing the risk of uterine hyperstimulation. Mechanical methods, such as the Foley catheter, are also employed to physically dilate the cervix and release endogenous prostaglandins, thereby promoting cervical ripening. The combination of mechanical and pharmacological methods is hypothesized to offer synergistic benefits, potentially leading to more efficient and successful labor induction. This trial aimed to directly compare these strategies to inform best practices.

This was a multicenter randomized clinical trial, the FOLCROM Trial, enrolling 169 women. Participants presented with premature rupture of membranes and were not yet in labor. They were randomized into two arms: one received oxytocin alone, and the other received oxytocin combined with a Foley catheter for labor induction. The primary endpoint was likely related to the efficacy and safety of labor induction, such as time to delivery or successful vaginal delivery rates, though specific details are not provided in the abstract. The trial was terminated before completion.