Cervical device reduces rate of preterm birth

Bottom Line: Pregnant women with a short cervix who used a small silicone ring called a cervical pessary to keep their cervix closed had a lower rate of preterm birth at less than 34 weeks.

Why The Research Is Interesting: Preterm birth is a major cause of illness, disability and death for infants. A cervical pessary is intended to keep the cervix closed and to change the inclination of the cervical canal but the results of randomized clinical trials have been contradictory.

Who and When: 300 women with a short cervix and without a history of sudden preterm births; the clinical trial was conducted from 2016-2017

What: Half of the woman had a cervical pessary inserted and half did not (intervention); spontaneous preterm birth at less than 34 weeks of gestation (outcome)

How (Study Design): This was a randomized clinical trial. Randomized clinical trials (RCTs) allow for the strongest inferences to be made about the true effect of an intervention. However, not all RCT results can be replicated in real-world settings because patient characteristics or other variables may differ from those that were studied in the RCT.

Authors: Gabriele Saccone, M.D., University of Naples Federico II, Naples, Italy and coauthors.

Results: Women who used a cervical pessary had a lower rate of spontaneous preterm birth.

Study Limitations: The trial was conducted at one facility and that raises questions about the generalizability of its findings.

Study Conclusions: Women with a short cervix and without a history of spontaneous preterm birth who used a cervical pessary had a lower rate of spontaneous preterm birth compared with women who did not use the device. The results must be confirmed in multicenter clinical trials.

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Related material: The following related elements also are available on the For The Media website:

• The editorial, "Cervical Pessary to Prevent Preterm Birth," by Robert M. Silver, M.D., and D. Ware Branch, M.D., of the University of Utah Health Sciences Center, Salt Lake City

For more details and to read the full study, please visit the For The Media website.

(doi:10.1001/jama.2017.18956

Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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