Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02405455 |
Other study ID # |
CEPEIC |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 2015 |
Est. completion date |
March 2021 |
Study information
Verified date |
March 2021 |
Source |
Maternal-Infantil Vall d´Hebron Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Cervical insufficiency (CI), responsible for 8% of preterm births (PB), is used to describe
painless cervical dilation leading to recurrent second-trimester pregnancy losses/births of
otherwise normal pregnancies. Structural weakness of cervical tissue was thought to cause or
contribute to these adverse outcomes. The term has also been applied to women with one or two
such losses/births or at risk for second-trimester pregnancy loss/birth. Cervical pessary and
cervical cerclage are both considered as preventive treatments in women at risk for PB. This
study aims to demonstrate that the cervical pessary could reduce the preterm birth rate
before 37 weeks of gestation in women with prior PB due to cervical insufficiency or in women
with prior PB and a short cervix in the current pregnancy.
Description:
Methods/Design: This is an open-label, pilot, multicentre, prospective, randomised controlled
trial (RCT). Enrolees are women with singleton pregnancies and previous PB based on CI
(primary intervention, <16 weeks) or in case of previous PB and a short cervical length in
current pregnancy ≤ 25 mm (secondary intervention, <24 weeks). Women are randomised (1:1)
either to cervical cerclage or pessary treatment. The primary outcome is the spontaneous
preterm birth rate before 34 weeks of gestation. The sample size was calculated, as a pilot
study, based on the estimated population that we will be able to recruit during the duration
of the trial: 60 women, 30 for each group (cervical cerclage and cervical pessary group) to
observe, at least a reduction in the PB rate < 34 weeks from 34% to 27% in the pessary group,
as does cerclage.
Discussion: The outcome of this study will show the effectiveness of a cervical cerclage and
of a cervical pessary in this group of patients.