Pro-omega-3, Reduction of Inflammation and Modulation of Prematurity (Pro-MEGA)

Université de Sherbrooke

Status: Unknown

Conditions: PPROM

Treatments: Dietary Supplement: Oleic acid; Dietary Supplement: MAG-DHA

Study type: Interventional

Funder types: Other

Identifiers

NCT03739463

MP-31-2018-2496

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups, including a placebo group

MAG-DHA

Experimental group

Description:

1500 MG of MAG-DHA per day until childbirth or for up to 2 weeks

Treatment:

Dietary Supplement: MAG-DHA

Placebo

Placebo Comparator group

Description:

1500 MG of oleic acid per day until childbirth or for up to 2 weeks

Treatment:

Dietary Supplement: Oleic acid