Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00329914
Status:
COMPLETED
Last Update Posted:
2011-07-25
First Post:
2006-05-24
Brief Title:
Does Progesterone Prevent Very Preterm Delivery in Twin Pregnancies
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Effectiveness of Vaginally Administered Progesterone to Prevent Preterm Delivery in Twin Pregnancies - A Multicentre Randomized Trial
Status:
COMPLETED
Status Verified Date:
2009-02
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:
None
Brief Summary:
The purpose of the study is to determine whether a daily dose of 200 mg progesterone administered vaginally from 20-23 to 34 weeks gestation will reduce the rate of preterm delivery amongst twin pregnancies
Detailed Description:
Multiple gestations account for 2 of all pregnancies but cause more than 10 of the cases of preterm delivery Due to increasing maternal age and use of assisted reproduction the number of multiple gestations is larger than ever If markers of preterm delivery can be identified and means of preventing preterm delivery are found it will be possible to reduce the number of children admitted to hospital because of prematurity
Recently two larger randomised studies investigated the effect of progesterone in singleton pregnancies of women who had previously delivered preterm They both found a significant reduction in the preterm delivery rate in the progesterone group compared to a placebo group
The study will be performed as a randomized double-blind placebo controlled study of twin pregnancies in Denmark and Austria The women will be randomised in a 11 ratio to two groups progesterone versus placebo Randomisation will be stratified per centre and according to chorionicity as the risk of preterm delivery is doubled in monochorionic twins compared to dichorionic twins
Recently two larger randomised studies investigated the effect of progesterone in singleton pregnancies of women who had previously delivered preterm They both found a significant reduction in the preterm delivery rate in the progesterone group compared to a placebo group
The study will be performed as a randomized double-blind placebo controlled study of twin pregnancies in Denmark and Austria The women will be randomised in a 11 ratio to two groups progesterone versus placebo Randomisation will be stratified per centre and according to chorionicity as the risk of preterm delivery is doubled in monochorionic twins compared to dichorionic twins
Study Oversight
Has Oversight DMC:
None
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?:
None