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

NCT03739463 — Not applicable, Unknown, 70 participants, Université de Sherbrooke

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Registry	NCT03739463, acronym Pro-MEGA
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, other
Enrollment	70 (Estimated)
Sponsor	Université de Sherbrooke (Other); collaborators: Laval University
Conditions	PPROM
Interventions	MAG-DHA, Oleic acid (Dietary supplement)
Dates	start 2018-12-03 (estimated), primary completion 2019-11-05 (estimated), completion 2020-05-15 (estimated), first posted 2018-11-13, last updated 2018-11-20

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
MAG-DHA	Experimental	Dietary Supplement: MAG-DHA	1500 MG of MAG-DHA per day until childbirth or for up to 2 weeks
Placebo	Placebo comparator	Dietary Supplement: Oleic acid	1500 MG of oleic acid per day until childbirth or for up to 2 weeks

MAG-DHA (Dietary supplement), also known as Pro-omega-3: 375 MG of MAG-DHA per capsules, two capsules BID
Oleic acid (Dietary supplement), also known as Sunflower oil: 375 MG of sunflower oil (oleic acid) per capsules, two capsules BID

+Outcome measures

Primary outcomes

Duration latency period [From PPROM through delivery]

Secondary outcomes

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

+Eligibility

Sex: Female, ages: 18 Years to 42 Years

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