NCT03739463

Pro-omega-3, Reduction of Inflammation and Modulation of Prematurity

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Université de Sherbrooke · Academic / Other
• Sex: Female
• Age: 18 Years – 42 Years
• Healthy volunteers: Not accepted

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.

Conditions

• PPROM

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	MAG-DHA	375 MG of MAG-DHA per capsules, two capsules BID
DIETARY_SUPPLEMENT	Oleic acid	375 MG of sunflower oil (oleic acid) per capsules, two capsules BID

Timeline

• Start date: 2018-12-03
• Primary completion: 2019-11-05
• Completion: 2020-05-15
• First posted: 2018-11-13
• Last updated: 2018-11-20