The ultrasound discovery of an SUA implies the meticulous search for other associated malformations, and in the absence of these, the risk of a chromosomal abnormality is very low, unless it is a high-risk patient. However, the growth and wellbeing of the fetus must be carefully monitored in the last 3 months, although the ultrasound scan does not show any other associated alterations.
OBJECTIVE:
To compare the effectiveness of a cervical pessary and vaginal progesterone to prevent spontaneous preterm births in pregnant women with cervical lengths 25 mm or less as measured by transvaginal ultrasonography.
METHODS:
This was a multicenter, open-label, randomized, noninferiority trial. Women with singleton pregnancies and a short cervix (25 mm or less) measured transvaginally at the second-trimester ultrasonogram were invited to participate. They were computer-randomized (one to one) into cervical pessary placement or treatment with vaginal progesterone (200 mg/24 hours). The primary outcome was spontaneous preterm delivery before 34 weeks of gestation. The noninferiority margin was set at 4% with a 0.025 one-sided α level and a statistical power of 80%. That is, if the 95% CI upper bound exceeded 4%, the pessary could not be deemed noninferior. A sample size of 254 women was required to show noninferiority of the pessary to progesterone.
RESULTS:
The trial was conducted from August 2012 to April 2016 with the participation of 27 Spanish hospitals. A total of 254 patients were enrolled and 246 included in the intention-to-treat analysis. Demographic and baseline characteristics were similar across groups. The rate of spontaneous delivery before 34 weeks of gestation was 14% (n=18/127) in the pessary group and 14% (n=17/119) in the progesterone group with a risk difference of −0.11% (95% CI −8.85% to 8.62%; P=.99), that is, noninferiority was not shown for the pessary. The incidence of increased vaginal discharge (87% vs 71%, P=.002) and discomfort (27% vs 3%, P<.001) was significantly higher in the pessary group.
CONCLUSION:
A cervical pessary was not noninferior to vaginal progesterone for preventing spontaneous birth before 34 weeks of gestation in pregnant women with short cervixes.
CLINICAL TRIAL REGISTRATION:
EU Clinical Trials Register, 2012-000241-13; ClinicalTrials.gov, NCT01643980.
Our rate of malformations associated with I-PRUV (17.9%) is similar to previously published rates. I-PRUV has shown a significant increase in the rate of associated malformations, although this association has only been found to be statistically significant in the genitourinary system. Noteworthy is the fact that this comparative study has not pointed to a significant increase in the congenital heart malformation rate. Diagnosis of isolated I-PRUV does not carry a worse prognosis.
It is important to properly assess the umbilical cord cyst and when is diagnosed, it is recommended to conduct a meticulous ultrasound examination searching for other associated malformations. In our study the prognosis of this finding seems to be favorable when isolated. Also, there is no relation between prognosis and gestation weeks at diagnosis. On the other hand, when we find this entity with associated anomalies, it is recommended to assess the need to carry out a karyotype.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.