Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2026-01-03 @ 11:07 PM
Study NCT ID:
NCT00536003
Status:
TERMINATED
Last Update Posted:
2012-06-06
First Post:
2007-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal Progesterone to Prevent Preterm Delivery in Women With Preterm Labor
Sponsor:
begoña Martinez de Tejada
Organization:
Study Overview
Official Title:
Prevention of Preterm Delivery With Vaginal Progesterone in Women With Preterm Labor
Status:
TERMINATED
Status Verified Date:
2012-06
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:
4P
Brief Summary:
The administration of vaginal progesterone, in addition to standard tocolysis, will decrease the risk of delivering prematurely and of recurrent preterm labor. We also hypothesize that the reduction in preterm delivery will be associated with a decrease in infant mortality and morbidity.
Detailed Description:
The principal aim is to demonstrate that progesterone reduces preterm birth before 37 weeks of gestation. Secondary aims are to show that progesterone 1) reduces preterm birth before 32 and before 34 weeks of gestation 2) reduces the number and duration of recurring episodes of preterm labor and 3) reduces infant mortality and morbidity.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| matped 04-001 | None | None | View |