PPROM
Conditions
Keywords
Pro-omega-3, Inflammation, Prematurity
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.
Interventions
DIETARY_SUPPLEMENTMAG-DHA
375 MG of MAG-DHA per capsules, two capsules BID
DIETARY_SUPPLEMENTOleic acid
375 MG of sunflower oil (oleic acid) per capsules, two capsules BID
Sponsors
Laval University
Université de Sherbrooke
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
* PPROM diagnosis, gestational age between 24 and 33 weeks of gestation.
Exclusion criteria
* multiple pregnancy, placenta previa, preeclampsia, retroplacental hematoma, chorioamnionitis, intrauterine growth retardation, severe fetal malformations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration latency period | From PPROM through delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite neonatal score | From birth through the first 28 days of life | 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 |
| Inflammatory status | Every 2-3 days from PPROM until delivery or a maximum of 14 days, whichever happens first | 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 |
Contacts
Primary ContactEric Rousseau, PhD
Backup ContactMarie-Belle Poirier, PhD
Outcome results
None listed