Ignite Creation Date:
2024-05-06 @ 12:21 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03739463
Status:
UNKNOWN
Last Update Posted:
2018-11-20
First Post:
2018-10-22
Brief Title:
Pro-omega-3 Reduction of Inflammation and Modulation of Prematurity
Sponsor:
Université de Sherbrooke
Organization:
Université de Sherbrooke
Study Overview
Official Title:
Pro-omega-3 Reduction of Inflammation and Modulation of Prematurity
Status:
UNKNOWN
Status Verified Date:
2018-10
Last Known Status:
NOT_YET_RECRUITING
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:
Pro-MEGA
Brief Summary:
The aim of the project is to decrease the inflammatory status of pregnant women with preterm premature rupture of membranes to delay the initiation of labour that would inevitably lead to premature delivery The main objective is to measure the mean duration between the initiation of the treatment and delivery in the two groups treated either with MAG-DHA or with the placebo
Detailed Description:
This randomized controlled trial will be conducted in two hospitals in the province of Quebec CHUS CHUQ- Site mère-enfant Soleil
Patients between 24 and 33 weeks of gestation with a diagnosis of preterm premature rupture of membranes PPROM who meet all inclusion and none of the exclusion criteria will be approached to participate Once they have signed the IFC participants will be randomized and begin a supplementation with either MAG-DHA or the placebo until delivery or for up to 2 weeks 14 days A total of 70 patients will be recruited
Principal outcome To compare the difference in duration between the start of treatment and delivery between the group receiving MAG-DHA and the group receiving placebo
Secondary outcomes 1 Evaluate the difference in neonatal outcome between children in the MAG-DHA group and those in the placebo group 2 Determine the inflammatory status of the patients associated with the exposure to either MAG-DHA or the placebo
This regimen could potentially represent an innovative approach in the management of women with a diagnosis of PPROM
Patients between 24 and 33 weeks of gestation with a diagnosis of preterm premature rupture of membranes PPROM who meet all inclusion and none of the exclusion criteria will be approached to participate Once they have signed the IFC participants will be randomized and begin a supplementation with either MAG-DHA or the placebo until delivery or for up to 2 weeks 14 days A total of 70 patients will be recruited
Principal outcome To compare the difference in duration between the start of treatment and delivery between the group receiving MAG-DHA and the group receiving placebo
Secondary outcomes 1 Evaluate the difference in neonatal outcome between children in the MAG-DHA group and those in the placebo group 2 Determine the inflammatory status of the patients associated with the exposure to either MAG-DHA or the placebo
This regimen could potentially represent an innovative approach in the management of women with a diagnosis of PPROM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None