NCT00646802

Vaginal PROgesterone as Maintenance Treatment After an epISode of prEterm Labor (PROMISE Study)

Vaginal Progesterone as a Maintenance Treatment in Women With Previous Preterm Labor. Randomized, Double Blinded, Placebo-controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 265 (actual)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Threatened Premature Labor

Interventions

Type	Name	Description
DRUG	Progesterone	1 vaginal capsule, 200 mg, once daily since gestation age 36 weeks and 6 days
DRUG	Placebo	1 vaginal capsule, once daily since gestational age of 36 weeks and 6 days

Timeline

• Start date: 2008-06-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2008-03-31
• Last updated: 2016-08-19

Locations

12 sites across 1 country: Spain