Pro-omega-3, Reduction of Inflammation and Modulation of Prematurity
NCT ID: NCT03739463
Last Updated: 2018-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
70 participants
INTERVENTIONAL
2018-12-03
2020-05-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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MAG-DHA
1500 MG of MAG-DHA per day until childbirth or for up to 2 weeks
MAG-DHA
375 MG of MAG-DHA per capsules, two capsules BID
Placebo
1500 MG of oleic acid per day until childbirth or for up to 2 weeks
Oleic acid
375 MG of sunflower oil (oleic acid) per capsules, two capsules BID
Interventions
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MAG-DHA
375 MG of MAG-DHA per capsules, two capsules BID
Oleic acid
375 MG of sunflower oil (oleic acid) per capsules, two capsules BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
42 Years
FEMALE
No
Sponsors
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Laval University
OTHER
Université de Sherbrooke
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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MP-31-2018-2496
Identifier Type: -
Identifier Source: org_study_id
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