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Cervical pessary use lowers preterm birth rate

Women who used a cervical pessary had a lower spontaneous preterm birth rate at less than 34 weeks of pregnancy compared with women who did not use a pessary, according to findings recently published in JAMA.

“Preterm birth is a major cause of perinatal morbidity and mortality,” Gabriele Saccone, MD, of the School of Medicine at the University of Naples in Italy, told Healio Family Medicine. “The cervical pessary is a silicone device that has been studied to prevent preterm birth. However, the efficacy of this device in preventing preterm birth is still subject of debate.”

Researchers randomly grouped 300 asymptomatic women (mean age, 29 years) from a single location in Italy in a 1:1 ratio. All had cervical lengths of 25 mm or shorter at 18 weeks 0 days to 23 weeks 6 days of gestation, singleton pregnancies and no prior spontaneous preterm births. Those who received the cervical pessary had the device removed when clinically indicated or between 37 weeks 0 days and 37 weeks 6 days of gestation. The other study participants received standard care.

Saccone and colleagues found that the primary endpoint — spontaneous preterm birth at less than 34 weeks of gestation — took place in significantly fewer women in the cervical pessary group (RR = 0.48; 95% CI; 0.24-0.95). In addition, the most significant adverse event in those receiving the cervical pessary was a higher rate of increased or new vaginal discharge (RR = 1.88; 95% CI; 1.57-2.27).

“Cervical pessary should be offered to women with singleton pregnancies and short cervix,” Saccone said in the interview. “Future trials should focus on [cervical pessary use in] different women at risk of preterm birth, including symptomatic women, women with arrested preterm labor, women with preterm premature rupture of membranes, women with cervical length, women with history of preterm birth, and also women with multiple gestations.”

In a related editorial, Robert M. Silver MD, of the department of obstetrics and gynecology at the University of Utah and D. Ware Branch, MD, of the Intermountain Healthcare in Salt Lake City, wrote that the results of previous smaller studies examining cervical pessaries had found benefit, similar to Saccone and colleagues’ findings, while others found no benefit, and that these conflicting results present a “substantial” conflict. They added that other data on preterm birth prevention methods suggest these approaches be considered on a patient-by-patient basis.

“Balancing clinical care that is evidence-based and cost conscious and that scrupulously avoids harm against well-intentioned but controversial care that might prevent serious morbidity and mortality is truly challenging. It is possible, however, to counsel and treat women using the best available data regarding pessary, cerclage, and progestogens while acknowledging the uncertainties regarding efficacy.”

“Most importantly, it is crucial that physicians accept that these interventions have not solved the problem of preterm birth. Although these approaches appear to work in some at-risk pregnant populations at least some of the time, they do not work in all at-risk pregnancies all of the time,” they added. “Moreover, it is a virtual certainty that one approach will be not be effective for all.” – by Janel Miller

Disclosure: Silver reports serving as a consultant for Gestavision. No other relevant financial disclosures were reported.