Cervical Pessary May Prevent Spontaneous Preterm Birth

Jennifer Garcia

December 19, 2017

Use of a cervical pessary may prevent spontaneous preterm birth in women with a shortened cervix in comparison to women who did not use the device, a study found.

This randomized controlled trial "showed that in asymptomatic women with singleton pregnancies without prior spontaneous preterm birth but with a transvaginal ultrasound cervical length of 25 mm or less, use of a cervical pessary resulted in a statistically significantly lower rate of spontaneous preterm birth than no pessary," write the authors of the study, which was published online December 19 in JAMA. 

Researchers from the University of Naples Federico II, Naples, Italy, enrolled 300 women (age 18 to 50 years) between March 1, 2016, and May 25, 2017. They randomly assigned the women to receive a cervical pessary (intervention group) or no pessary (control group). The women were at 18 weeks 0 days to 23 weeks 6 days of gestation at the time of randomization.

Women were evaluated every month until delivery, and all women with cervical length of 20 mm or less were prescribed vaginal progesterone suppositories (200 mg/day) until 36 weeks 6 days of gestation. Among women in the intervention group, the pessary was removed during the 37th week of gestation or earlier if indicated.

The researchers found that 7.3% (11 of 150) of women in the pessary group experienced spontaneous preterm birth at less than 34 weeks of gestation compared with 15.3% (23 of 150) of women in the control group (between-group difference, –8.0 percentage points; 95% confidence interval [CI], –15.7 to –0.4 percentage points).

Although no differences in pelvic discomfort were reported between the two groups, the authors note that women in the pessary group had a higher rate of new vaginal discharge (86.7% vs 46%; between-group difference, 40.7 percentage points; 95% CI, 30.1 - 50.3 percentage points). No injuries due to insertion or removal of the device were reported.

Acknowledging "the exploratory nature of the secondary outcomes," the researchers also reported longer gestational age at delivery, higher birth weight, and lower incidence of a composite of adverse neonatal outcomes among women in the pessary group.

The study authors recognize that the results of the current trial contradict findings from previous studies that demonstrated no benefit in pessary use. They hypothesize that population differences (including variable cervical lengths) as well as differences in training of personnel in pessary placement may have played a role in study outcomes. The researchers also acknowledge that the single-center trial design may limit the generalizability of these findings. 

"The conundrum posed by conflicting trial results is substantial," and "it is important to be cautious prior to universal adoption of pessaries," write Robert M. Silver, MD, and D. Ware Branch, MD, from the University of Utah Health Sciences Center and the Women and Newborns Clinical Program of Intermountain Healthcare, in Salt Lake City, respectively, in an accompanying editorial.

Dr Silver and Dr Branch agree with the study authors that while these results are promising, further studies are warranted. They suggest that until more data are available, physicians should seek "to counsel and treat women using the best available data regarding pessary, cerclage, and progestogens while acknowledging the uncertainties regarding efficacy."

The authors and editorialists have disclosed no relevant financial relationships.

JAMA. Published online December 19, 2017. Abstract, Editorial

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