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

Not Applicable

• Conditions: PPROM
• Interventions: Dietary Supplement: MAG-DHA; Dietary Supplement: Oleic acid

• Registration Number: NCT03739463
• Lead Sponsor: Université de Sherbrooke

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.

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-22
• Study First Submitted QC: 2018-11-09
• Study First Posted: 2018-11-13
• Last Update Submitted: 2018-11-19
• Last Update Posted: 2018-11-20
• Study Start: 2018-12-03
• Primary Completion: 2019-11-05
• Study Completion: 2020-05-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MAG-DHA	MAG-DHA	1500 MG of MAG-DHA per day until childbirth or for up to 2 weeks
Placebo	Oleic acid	1500 MG of oleic acid per day until childbirth or for up to 2 weeks

Primary Outcome Measures

Name	Time	Method
Duration latency period	From PPROM through delivery

Secondary Outcome Measures

Name	Time	Method
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