Monday’s Samuel A. Cosgrove Memorial Lecture took a closer look at doing cervical ripening on an outpatient basis for low-risk patients.
The debate mostly focused on mechanical dilation with a balloon catheter. Anthony C. Sciscione, DO, Christiana Care Health Services, Newark, DE, spoke in favor of outpatient cervical ripening and talked about his use of the Foley catheter in his institution. William F. Rayburn, MD, MBA, University of New Mexico, Albuquerque, NM, questioned the value of outpatient cervical ripening given limited research data.
Dr. Sciscione said his own experience and other studies show that outpatient cervical ripening leads to a significant increase in patient satisfaction. Most women are more willing to accept more trips to the hospital and increased travel time to have outpatient cervical ripening. In fact, the inpatient group in one study showed an increase in anxiety compared with the outpatient group.
A randomized trial at Christiana Care tried to determine how well patients could manage the Foley catheter in an outpatient setting. Women who fit the low-risk criteria had a catheter placed and were then randomized into inpatient (n=50) and outpatient (n=61) groups and observed for two hours.
Those in the outpatient group were discharged with instructions, while the inpatient group went to labor and delivery. Dr. Sciscione said there was no real difference between the groups. There was an increased risk of cesarean delivery in the inpatient group, but that result was not statistically significant.
The protocol at Christiana Care requires a woman to be low risk with cervix less that 3 cm. Those with abnormal vital signs or amniotic fluid levels go to labor and delivery. The rest go home and are told to return at 6 am the next day.
Dr. Rayburn cautioned the audience about assuming that outpatient cervical ripening was as safe as inpatient cervical ripening. He noted that Up to Date does not recommend outpatient cervical ripening at this time except in the research setting, and the most recent ACOG Practice Bulletin and top textbooks have no comments on the subject. His review found that less than 10 percent of all publications related to cervical ripening deal with outpatient experiences.
“What we all would agree with here, I assume, is that whatever we do with this procedure, we want to add as little, or ideally, no additional risk to the mother and the fetus, so we’ve got to have sufficient experience to really say that,” he said.
In researching for the debate, Dr. Rayburn said he found three random clinical trials involving outpatient mechanical dilation. While the trials, one of which was led by Dr. Sciscione, all came to the same positive conclusions, the number of patients who received outpatient cervical ripening with a balloon catheter was small, at 141.
Dr. Rayburn didn’t find any evidence that outpatient cervical ripening reduced cost. He also questioned potential difficulties in transportation to the hospital for patients and consistency in monitoring before and during therapy and with patient instructions.
While adverse events are rare, Dr. Rayburn said, there’s no consensus on what constitutes unacceptable risk.
“Ideally, what we should do is a large randomized trial or meta-analysis. Not only have 140 patients or so, but really thousands to really exclude excess risk here. But I don’t think we have the money for that,” he said.