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Cervical pessaries and preterm birth prevention
Placing a cervical pessary may not be enough to prevent preterm birth (PTB), according to results of a multicenter randomized controlled trial presented at the 37th annual Pregnancy Meeting for the Society for Maternal-Fetal Medicine, in Las Vegas, Nevada.
The researchers included asymptomatic women with singleton gestations with a transvaginal ultrasound (TVU) cervical length (CL) ≤ 25 mm at 180 to 236 weeks and no prior PTB. The women were randomly assigned to receive the Bioteque cup pessary or no pessary and the pessaries were inserted by maternal-fetal medicine staff trained in proper placement. Randomization was stratified by CL (≤ 20 mm or >20-25 mm) and study site. Any women with a TV CL ≤ 20 mm were recommended for treatment with vaginal progesterone. Analysis was by intention-to-treat and the researchers required a total sample size of 242.
Of a total of 17,388 screened for TVU CL, 446 (2.6%) were found to have a TVI CL ≤ 25 mm. Three hundred ninety-four (88.3%) met the eligibility criteria and 122 (31.0%) agreed to be randomized. When the study was submitted for the meeting, 111 of the women had delivered: 56 in the pessary and 55 in the no pessary group. Demographic characteristics were similar across both groups and no significant differences were seen between the pessary and no pessary group in the rates of PTB < 37 weeks, PTB < 34 weeks, PTB < 28 weeks, gestational age at delivery, birth weight, and composite neonatal outcome.
The investigators concluded that treatment with a cervical pessary did not appear to prevent PTB in women with a singleton gestation and a TVU CL ≤ 25 mm at 180 to 236 weeks. The study recruitment was halted before the researchers were able to meeting their enrollment, but they state that the findings are similar to other recent studies that have also found pessaries to be ineffective.