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| Name | Class |
|---|---|
| Laval University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAG-DHA | Experimental | 1500 MG of MAG-DHA per day until childbirth or for up to 2 weeks |
|
| Placebo | Placebo Comparator | 1500 MG of oleic acid per day until childbirth or for up to 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAG-DHA | Dietary Supplement | 375 MG of MAG-DHA per capsules, two capsules BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration latency period | From PPROM through delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Composite neonatal score | Composite neonatal score includes any one or more of the following: acute respiratory distress, bronchopulmonary dysplasia, proven sepsis, necrotizing enterocolitis, severe intraventricular hemorrhage (grade> 2) or periventricular leukomalacia | From birth through the first 28 days of life |
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Inclusion Criteria:
Exclusion Criteria:
Pregnacy required
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric Rousseau, PhD | Contact | 819-346-1110 | 75306 | eric-rousseau@usherbrooke.ca |
| Marie-Belle Poirier, PhD | Contact | 8193461110 | 12865 | Marie-Belle.Poirier@USherbrooke.ca |
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| ID | Term |
|---|---|
| C563032 | Preterm Premature Rupture of the Membranes |
| D007249 | Inflammation |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
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| ID | Term |
|---|---|
| C575982 | docosahexaenoic acid monoacylglyceride |
| D019301 | Oleic Acid |
| D000074242 | Sunflower Oil |
| ID | Term |
|---|---|
| D009829 | Oleic Acids |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
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| Oleic acid | Dietary Supplement | 375 MG of sunflower oil (oleic acid) per capsules, two capsules BID |
|
|
| Inflammatory status |
Inflammatory status will be determined based on the quantification of any one or more of the following biomarkers in blood and vaginal secretions specimens: resolvins, lipoxygenase isoforms |
| Every 2-3 days from PPROM until delivery or a maximum of 14 days, whichever happens first |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D008055 |
| Lipids |
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |