Preterm Birth Clinical Trial
Official title:
Progesterone and Cervical Pessary in Twins : A Prospective and Randomized Study to Prevent Preterm Birth (PRECEPT)
The aim of this randomized control trial is to determine wheter cervical pessary plus vaginal progesterone (400mg) reduce preterm birth less than 34 weeks of gestacion and improve perinatal outcome, among women presenting asyntomatic short cervix, in twin pregnancy.
The frequency of twin pregnancies has increased significantly, especially because of the
assisted reproduction and advanced maternal age at conception. The twin pregnancies are
responsible for 25 % of all preterm birth. Consequently, twin pregnancies are more
associated with perinatal mortality and morbidity when compared to single pregnancies.
Additionally, the short cervix (< 25 mm) in singleton and twin pregnancies are associated
with significantly increased preterm birth.
Randomized controlled trials in singleton pregnancies reported that profilatic cervical
cerclage and vaginal progesterone reduce significantly the rate of early preterm birth. In
twin pregnancies, vaginal progesterone and profilatic cerclage have been shown to be
ineffective in prevention of preterm birth.
However, two individual pacient data meta-analyses reported in a subgroup of women with twin
pregancies and short cervix, that vaginal progesterone reduce significantly adverse neonatal
outcomes. Nowadays, the effet of cervical pessary is contraditory, mainly in women with
short cervix.
This is a randomized prospective trial at São Paulo University Medical School. This trial
will involve 312 women with twins pregnancies and short cervix between 16 and 27 weeks and 6
days of gestacional age. Women with twin pregnancy and short cervix ( defined according to
the gestacional age ) will be assigned randomly to daily vaginal progesterone (400mg)
combined with insertion of cervical pessary, isolated use of daily vaginal progesterone
(400mg) isolated insertion of cervical pessary or expectant management (no intervention).
The primary outcome is to compare the rate of spontaneous delivery < 34 weeks of gestacion
between groups.The secondary outcome is to compare the neonatal adverse outcome between the
groups.
The aim of this study is to test the hypothesis that the insertion of a cervical pessary
combined with vaginal progesterone, in twin pregnancies with short cervix would reduce the
spontaneus preterm birth < 34 weeks' gestation.
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