Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-02-25 @ 7:07 PM
Study NCT ID:
NCT00646802
Status:
COMPLETED
Last Update Posted:
2016-08-19
First Post:
2008-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal PROgesterone as Maintenance Treatment After an epISode of prEterm Labor (PROMISE Study)
Sponsor:
Hospital Clinic of Barcelona
Organization:
Study Overview
Official Title:
Vaginal Progesterone as a Maintenance Treatment in Women With Previous Preterm Labor. Randomized, Double Blinded, Placebo-controlled Trial
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMISE
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: