DALLAS — Use of the AMOR-IPAT protocol did not significantly reduce cesarean deliveries in a prospective randomized trial of 270 women.
AMOR-IPAT (Active Management of Risk in Pregnancy at Term), a controversial approach, involves prostaglandin-assisted preventive labor induction based on a risk-scoring system, Dr. James Nicholson reported at the annual meeting of the Society for Maternal-Fetal Medicine.
The women enrolled in the study had at least one of six specific risk factors for delivery and were randomized at 37 weeks, 4 days' gestation to either AMOR-IPAT (n = 136) or usual care (n = 134). Their mean age was 23 years.
As expected, the AMOR-IPAT group experienced significantly higher rates of labor induction (60% vs. 22%) and prostaglandin usage (40% vs. 16%), and were delivered, on average, 1 week earlier than the usual-care group.
In an intent-to-treat analysis, the rate of cesarean delivery was not significantly different between the AMOR-IPAT and usual-care groups (10% vs. 15%).
However, the AMOR-IPAT group had a significantly lower neonatal intensive care unit admission rate of 1.5% compared with 6.7%.
In addition, two composite outcomes—uncomplicated vaginal birth (74% vs. 63%) and adverse outcome index (AOI) scores (mean 1.4 vs. 8.6)—were significantly improved in the AMOR-IPAT group.
“AMOR-IPAT may represent a legitimate response to our nation's increasing rates of adverse term outcomes,” said Dr. Nicholson of the department of family medicine and community health, University of Pennsylvania, Philadelphia.
Audience members were quick to point out that the study failed to achieve its primary goal of lowering cesarean delivery rates and that some of the deliveries went against the current American College of Obstetricians and Gynecologists' recommendation to avoid delivery before 39 weeks' gestation.
Dr. Nicholson responded that the study included only women with very good ultrasound-based dating, and that while a significant number of women were delivered during their 38th week, the protocol actually led to fewer infants going to the neonatal intensive care unit.
“Clearly there is a conflict between our current methods of care and this method of care, so there would need to be changes in labor and delivery for structure and process if this method were to be used,” he said.
“During this conference I've heard a lot about the AOI scores … and I would suggest that if the AOI scores are really improved to the level seen in this study that we might take a look at our processes of care and consider some significant changes,” Dr. Nicholson commented.
Two previous retrospective, nonrandomized studies showed a significant decrease in cesarean deliveries with the AMOR-IPAT protocol (Ann. Fam. Med. 2007;5:310–9; Am. J. Obstet. Gynecol. 2004;191:1516–28).
The study was funded jointly by the National Institutes of Health and the First Hospital Foundation.
Dr. Nicholson disclosed that Forest Pharmaceuticals provided free samples of its dinoprostone cervical-ripening product to the university's hospital, but that none of the samples were used during the study.