A Randomized Controlled Trial of Early Amniotomy versus Delayed Amniotomy Following Foley Balloon Ripening in Nulliparous Labor Induction

The care of pregnant women has become more complex as advancements have allowed women affected by chronic medical conditions and those whose neonates require complex coordination of care to have successful pregnancy outcomes. Many of these women will require inductions of labor, as prolonging pregnancy can result in adverse outcomes. As such, induction of labor has become one of the most common procedures performed in obstetrics. Research has shown that, compared to spontaneous labor, induction of labor results in increased time in labor and hospital costs, and decreased patient satisfaction. Despite the increasingly common and necessary practice of induction of labor, the optimal method remains largely unknown. Research suggests that initiating an induction by mechanically ripening the cervix with a Foley balloon catheter results in a decrease in length of labor and rate of cesarean delivery. Following cervical ripening, induction is often continued using amniotomy (breaking the bag of water), however the optimal timing remains controversial. While some available literature suggests that early amniotomy results in decreased length of labor, other research has shown this to be associated with no change in labor duration but an increased rate of cesarean section. Unfortunately, these studies’ methods were susceptible to biases. Thus, this proposal seeks to addresses this critical unanswered question using a randomized controlled trial, with the hopes of leading to optimized maternal and neonatal outcomes, improved patient satisfaction and reduced health care costs.