Vaginal PROgesterone as Maintenance Treatment After an epISode of prEterm Labor (PROMISE Study)
Status:
Completed
Trial end date:
2012-05-01
Target enrollment:
Participant gender:
Summary
Eligible patients will be informed and asked to enroll in the study at hospital admission. A
transvaginal ultrasound examination will be performed to determine cervical length. If an
eligible woman accepts to participate, patient will be randomized to one of the study arms
assigned in a double blind basis. Patient will receive the medication (vaginal capsule of
progesterone or placebo). The patient will administer herself one vaginal capsule in a daily
basis since gestational age of 36 weeks and 6 days as the primary endpoint is to demonstrate
that the use of a maintenance treatment with vaginal progesterone is able to reduce the
incidence of preterm birth before 34.0 and 37.0 gestational weeks. After delivery, perinatal
and neonatal data will be collected.