To evaluate neonatal outcomes after the use of a cervical pessary in Japanese women with short cervical length (CL) less than 25 mm.
This multicenter study involved women with singleton pregnancies between 20 and 29+6 gestational weeks and a CL of less than 25 mm. The primary outcome was preterm birth (PTB) before 34 weeks of gestation. This study was registered in the Japan Registry of Clinical Trials (JRCT: jRCTs042180102).
Two hundred pregnant women were enrolled; 114 in the pessary group and 86 in the expectant management group as controls. In the pessary group, all 114 neonates were investigated for perinatal outcomes, and 112 pregnant women were investigated for primary, and secondary outcomes. In the control group, 86 pregnant women were investigated for primary and secondary outcomes and 86 neonates were investigated for neonatal outcomes. There were no significant differences in PTB in ≤34, ≤37, and ≤28 weeks of gestation or in preterm rupture of membranes (PROM) ≤34 weeks between the groups. The gestational weeks at birth and birth weight were significantly higher in the pessary group. Regression analysis demonstrated that the CL decreased without a pessary, whereas the shortening rate was suppressed during the intervention. No significant differences were observed in adverse neonatal outcomes, chorioamnionitis, or preterm PROM.
The cervical pessary effectively reduced CL shortening during pregnancy resulting in an average increased gestational age, however, did not reduced the rates of preterm birth.
Research funding: None declared.
Author contributions: KK, JM, SD, MN, AN, MO, YO designed the study and was involved in the preparation of the study. KK, JM, SD, NN, NK, MN, YO collected the data, and SO, HH analyzed the data. KK, YO was involved in the preparation of the manuscript. All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Competing interests: Authors state no conflict of interest.
Informed consent: Informed consent was obtained from all individuals included in this study.
Ethical approval: This study was conducted from December 2016 to September 2020 and approved by the Nagoya City University Hospital Clinical Research Review Board (CRB4180001). It was also registered in the Japan Registry of Clinical Trials (JRCT) as the “Preterm labor prevention, multicenter study for maternal cervical pessary (LOVE MOM)” trial (jRCTs042180102).
Data availability: Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study.
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