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N Engl J Med. 2016 Mar 17;374(11):1044-52. doi: 10.1056/NEJMoa1511014.

A Randomized Trial of a Cervical Pessary to Prevent Preterm Singleton Birth.

Author information

1
From the Harris Birthright Research Center for Fetal Medicine, King's College, London (K.H.N., A.S., L.C.P., A.Z., E.S., J.R.C.), and the Department of Fetal Medicine, Medway Maritime Hospital, Gillingham (G.P.) - both in the United Kingdom; Department of Perinatology, University Medical Center Ljubljana, Slovenia (N.T.); Fetal Medicine Unit, Hospital Clinico Universidad de Chile, Santiago, Chile (M.P.-C.); and Pregnancy Research Center, Royal Women's Hospital, Melbourne, VIC, Australia. (R.P.-D.).

Abstract

BACKGROUND:

Preterm birth is the leading cause of neonatal and infant death and of disability among survivors. It is unclear whether a pessary inserted around the cervix reduces the risk of preterm singleton birth.

METHODS:

We conducted a multicenter, randomized, controlled trial comparing pessary placement with expectant management (control) in girls and women who were pregnant with singletons (singleton pregnancies) and who had a cervical length of 25 mm or less at 20 weeks 0 days to 24 weeks 6 days of gestation. Participants in either group who had a cervical length of 15 mm or less, at randomization or at subsequent visits, received treatment with vaginal progesterone. The primary outcome was spontaneous delivery before 34 weeks of gestation.

RESULTS:

In an intention-to-treat analysis, there was no significant difference between the pessary group (465 participants) and the control group (467 participants) in the rate of spontaneous delivery before 34 weeks (12.0% and 10.8%, respectively; odds ratio in the pessary group, 1.12; 95% confidence interval, 0.75 to 1.69; P=0.57). There were no significant differences in the rates of perinatal death (3.2% in the pessary group and 2.4% in the control group, P=0.42), adverse neonatal outcome (6.7% and 5.7%, respectively; P=0.55), or neonatal special care (11.6% and 12.9%, respectively; P=0.59). The incidence of new or increased vaginal discharge was significantly higher in the pessary group than in the control group.

CONCLUSIONS:

Among girls and women with singleton pregnancies who had a short cervix, a cervical pessary did not result in a lower rate of spontaneous early preterm delivery than the rate with expectant management. (Funded by the Fetal Medicine Foundation; Current Controlled Trials number, ISRCTN01096902.).

PMID:
26981934
DOI:
10.1056/NEJMoa1511014
[Indexed for MEDLINE]
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