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TOPLINE: 

A study comparing cervical pessary and vaginal progesterone for the prevention of preterm birth in women with a short cervix of ≤ 35 mm found no significant difference between the interventions for perinatal complications. Among women with a cervical length of ≤ 25 mm, however, pessaries appeared to be less effective at preventing spontaneous preterm birth and adverse outcomes, according to the researchers. 

METHODOLOGY:

• Researchers conducted an open-label, randomized controlled trial at 20 hospitals and five obstetric ultrasound practices in the Netherlands.
• The study included 635 women with healthy singleton pregnancies between 18 and 22 weeks' gestation and an asymptomatic short cervix of ≤ 35 mm. Participants had no history of spontaneous preterm birth.
• Women were randomly assigned to receive either an Arabin cervical pessary or 200 mg/d vaginal progesterone for ≤ 36 weeks of gestation.
• The investigators examined a composite measure of adverse perinatal outcomes, including periventricular leukomalacia (grade, > 1), chronic lung disease, intraventricular hemorrhage (grade, III or IV), necrotizing enterocolitis (stage, > 1), sepsis, stillbirth, and death of the baby.

TAKEAWAY: 

• Adverse perinatal outcomes occurred in 6% of each treatment group, and the rate of spontaneous preterm birth did not differ significantly between the groups.
• In a subgroup analysis of 131 patients with a cervical length of ≤ 25 mm, spontaneous preterm birth at < 28 weeks occurred more often in the pessary group (16% vs 4%).
• Adverse perinatal outcomes also seemed to occur more frequently in the pessary group (24% vs 12%; relative risk, 2.1 [95% CI, 0.95-4.60]), in the subgroup analysis, according to the researchers.

IN PRACTICE:

"Even though the study was not powered for the subgroup with a short cervix of ≤ 25 mm, results suggest that a cervical pessary should not be used as preventive treatment in this group," the researchers wrote. 

SOURCE:

The study was led by Charlotte E van Dijk, MD, with Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands. It was published online on March 12, 2024, in The BMJ. 

LIMITATIONS:

The researchers were unable to mask the treatment groups, which could introduce bias. The study's reliance on self-reported medication adherence in the progesterone group and a lack of extra training for pessary placement might have influenced the outcomes, the researchers noted.

DISCLOSURES:

The study was supported by Stichting Stoptevroegbevallen, a nonprofit research foundation. An author disclosed financial ties with Merck. 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.