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

PPROM Clinical Trial

— Pro-MEGA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03739463
• Other study ID #: MP-31-2018-2496
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: May 15, 2020

Study information

• Verified date: October 2018
• Source: Université de Sherbrooke
• Contact: Eric Rousseau, PhD
• Phone: 819-346-1110
• Email: eric-rousseau[@]usherbrooke.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: May 15, 2020
• Est. primary completion date: November 5, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• PPROM
• Premature Birth

Intervention

Dietary Supplement:
• MAG-DHA
375 MG of MAG-DHA per capsules, two capsules BID
• Oleic acid
375 MG of sunflower oil (oleic acid) per capsules, two capsules BID

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	Laval University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration latency period		From PPROM through delivery
Secondary	Composite neonatal score	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	From birth through the first 28 days of life
Secondary	Inflammatory status	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	Every 2-3 days from PPROM until delivery or a maximum of 14 days, whichever happens first