A cervical pessary does not reduce the rate of spontaneous early preterm birth in women and girls with a shortened cervix compared with expectant management, a new multicenter, randomized controlled trial shows.
Kypros H. Nicolaides, MD, from the Harris Birthright Research Center for Fetal Medicine, King's College, London, United Kingdom, and colleagues report their findings in an article published in the March 17 issue of the New England Journal of Medicine.
A cervical pessary is a silicone device that is placed around the cervix transvaginally. It supports the cervix and reduces direct pressure from the uterus on the cervical canal by directing the cervix toward the sacrum.
The trial enrolled females aged at least 16 years with singleton pregnancies who had routine ultrasonographic examination at between 20 weeks 0 days and 24 weeks 6 days of gestation that showed a cervical length of 25 mm or less. Those with a cervical length of 15 mm or less at any time during the study were also treated with vaginal progesterone.
The researchers randomly assigned 466 participants to the cervical pessary group and 469 to the expectant management group.
Spontaneous birth before 34 weeks' gestation, which was the primary endpoint of the trial, occurred in 55 (12.0%) of those in the pessary group and 50 (10.8%) of those in the control group (odds ratio [OR] in the pessary group, 1.12; 95% confidence interval [CI], 0.75 - 1.69; P = .57).
Moreover, the cumulative percentage of women and girls who did not deliver spontaneously before 34 weeks was not significantly different between the two groups (hazard ratio in the pessary group, 1.13; 95% CI, 0.77 - 1.65; P = .54).
At trial recruitment, the rate of reported vaginal discharge was higher in the cervical pessary group than the control group (10.5% vs 6.2%; P = .02), but the rate of pelvic discomfort was not (1.9% and 0.6%, respectively; P = 0.14).
During follow-up, the rate of increased or new vaginal discharge (46.8% vs 13.8%; P < .001) and pelvic discomfort (11.4% vs 3.4%; P < .001) were both higher in the cervical pessary group.
The pessary group and the control group had similar percentages of participants with pathogens in the vaginal swabs, including Candida albicans, group B streptococcus, or Gardnerella vaginalis, both at recruitment (28.6% and 25.8%, respectively; P = .39) and at any time during follow-up (31.4% and 30.0%, respectively; P = .75).
"Although the rate of new or increased vaginal discharge was more than three times as high in the pessary group as in the control group, rates of cervicovaginal infection did not differ significantly between the groups," the researchers write.
Of those with cervical pessaries, 114 (24.5%) had them removed before 34 weeks' gestation for reasons including iatrogenic delivery (six participants), preterm labor (20 participants), preterm labor or prelabor rupture of membranes (41 participants), and participant request (47 participants; 25 for discomfort, 19 for vaginal discharge, and 3 for vaginal bleeding).
The researchers found no significant between-group differences in perinatal death (OR, 1.38; 95% CI, 0.63 - 3.04; P = .42), adverse neonatal event (OR, 1.18; 95% CI, 0.69 - 2.03; P = .55), or neonatal special care (OR, 0.88; 95% CI, 0.59 - 1.31; P = .59).
"[A]mong girls and women with singleton pregnancies who had a cervical length of 25 mm or less at 20 to 24 weeks of gestation, placement of a cervical pessary did not result in a lower rate of spontaneous early preterm delivery than the rate with expectant management," conclude the researchers. "Pessary placement also did not affect the rates of perinatal death, adverse neonatal outcomes, or the need for neonatal special care."
The authors have disclosed no relevant financial relationships.
N Engl J Med. 2016;374:1044-1052. Full text
Medscape Medical News © 2016 WebMD, LLC
Send comments and news tips to news@medscape.net.
Cite this: Cervical Pessary Does Not Reduce Early Preterm Birth - Medscape - Mar 17, 2016.
Comments