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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
265
1 vaginal capsule, 200 mg, once daily since gestation age 36 weeks and 6 days
1 vaginal capsule, once daily since gestational age of 36 weeks and 6 days
Hospital Son Llàtzer
Palma de Mallorca, Balearic Islands, Spain
Institut Universitari Dexeus
Barcelona, Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Barcelona, Spain
Hospital Sant joan de Déu de Manresa
Manresa, Barcelona, Spain
Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain
Hospital de Terrassa. CST
Terrassa, Barcelona, Spain
Hospital de Basurto
Bilbao, Bilbao, Spain
Hospital Puerta del Mar
Cadiz, Cádiz, Spain
Complejo Hospitalario Universitario Insular-Materno Infantil
Las Palmas de Gran Canaria, Gran Canaria, Spain
Hospital U Gregorio Marañon
Madrid, Madrid, Spain
...and 2 more locations
Proportion of deliveries before week 34 of gestation
Time frame: week 34 of gestation
Median time from randomization to delivery
Time frame: delivery
Ultrasound cervical length
Time frame: week +5
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