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Cervical pessary placement for prevention of preterm birth in unselected twin pregnancies: a randomized controlled trial

Published:August 27, 2015DOI:https://doi.org/10.1016/j.ajog.2015.08.051

      Background

      Preterm birth is the leading cause of neonatal death and handicap in survivors. Although twins are found in 1.5% of pregnancies they account for about 25% of preterm births. Randomized controlled trials in singleton pregnancies reported that the prophylactic use of progestogens, cervical cerclage and cervical pessary reduce significantly the rate of early preterm birth. In twin pregnancies, progestogens and cervical cerclage have been shown to be ineffective in reducing preterm birth.

      Objective

      The objective of this study was to test the hypothesis that the insertion of a cervical pessary in twin pregnancies would reduce the rate of spontaneous early preterm birth.

      Study Design

      This was a multicenter, randomized controlled trial in unselected twin pregnancies of cervical pessary placement from 20+0–24+6 weeks’ gestation until elective removal or delivery vs. expectant management. Primary outcome was spontaneous birth <34 weeks. Secondary outcomes included perinatal death and a composite of adverse neonatal outcomes (intraventricular haemorrhage, respiratory distress syndrome, retinopathy of prematurity or necrotizing enterocolitis) or need for neonatal therapy (ventilation, phototherapy, treatment for proven or suspected sepsis, or blood transfusion). Analysis was by intention to treat. This trial is registered in the ISRCTN registry, number 01096902.

      Results

      A total of 1,180 (56.0%) of the 2,107 eligible women agreed to take part in the trial; 590 received cervical pessary and 590 had expectant management. Two of the former and one of the latter were lost to follow up. There were no significant differences between the pessary and control groups in rates of spontaneous birth <34 weeks (13.6% vs. 12.9%; relative risk 1.054, 95% confidence interval [CI] 0.787-1.413; p=0.722), perinatal death (2.5% vs. 2.7%; relative risk 0.908, 95% CI 0.553-1.491; p=0.702), adverse neonatal outcome (10.0 vs. 9.2%; relative risk 1.094, 95% CI 0.851-1.407; p=0.524) or neonatal therapy (17.9% vs. 17.2%; relative risk 1.040, 95% CI 0.871-1.242; p=0.701). A post hoc subgroup analysis of 214 women with short cervix (≤25 mm) showed no benefit from the insertion of a cervical pessary.

      Conclusion

      In women with twin pregnancy, routine treatment with cervical pessary does not reduce the rate of spontaneous early preterm birth.

      Key words

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      Linked Article

      • Cervical pessary placement for prevention of preterm birth in unselected twin pregnancies: a randomized controlled trial
        American Journal of Obstetrics & GynecologyVol. 214Issue 2
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          We have read with interest the article by Nicolaides et al.1 It is noteworthy that the authors reported a high rate of removal of the cervical pessary. Specifically, this occurred in 22.3% of cases before 34 weeks of gestation. However, it would be interesting to know the gestational age at delivery (mean, interquartile range, and range) of these patients.
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        American Journal of Obstetrics & GynecologyVol. 214Issue 2
        • Preview
          We thank Drs Goya and Cabero for their comments. Our trial involved 1180 unselected twin pregnancies randomized at 20+0 to 24+6 weeks’ gestation to cervical pessary vs expectant management; there was no significant difference between the groups in spontaneous birth < 34 weeks (13.6% vs 12.9%), which was the primary outcome of the study. In both groups there was an inverse correlation between the cervical length at randomization and the rate of spontaneous birth at < 34 weeks, which was not significantly different between the 2 groups.
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