This study is designed to assess the effectiveness of a combination method of induction of
labor using a urinary balloon catheter and prostaglandin gel.
The vaginal delivery rate for medical induction of labor is lower than the vaginal delivery
rate for spontaneous labor. As a consequence, the frequency of cesarean section for failed
induction in the United States is rising. This has led to a renewed effort to examine the
effectiveness of the varied methods of induction.
The study is a randomized, unblinded trial of urinary balloon catheter and prostaglandin gel
for induction of labor in term pregnant patients. Pregnant women presenting to the Palmetto
Health Richland for a scheduled induction of labor will be offered enrollment in the trial.
Patients who enroll in the study will be randomized into one of 3 study arms: urinary balloon
catheter only, prostaglandin gel only and combination urinary balloon catheter and
prostaglandin gel. Randomization will be per sealed envelope from the locked nurse medication
storage area (Pyxis) located in Labor and Delivery at Palmetto Health Richland. The
investigator will be given the next sequentially numbered study randomization envelope by the
patient's nurse. The randomization assignment will be unblinded to the patient and her
physicians. If the patient is not in active labor 6 hours after initiation of the
intervention, a standardized protocol of oxytocin will commence. Labor management will be at
the discretion of the physician.