PPROMPro-MEGANCT03739463
Pro-omega-3, Reduction of Inflammation and Modulation of Prematurity
A study testing MAG-DHA and Oleic acid in people with PPROM, run by Université de Sherbrooke.
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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- PPROM
- What is being tested?
- MAG-DHA and Oleic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 3 Dec 2018to 15 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- PPROM diagnosis, gestational age between 24 and 33 weeks of gestation.
Who cannot join
- multiple pregnancy, placenta previa, preeclampsia, retroplacental hematoma, chorioamnionitis, intrauterine growth retardation, severe fetal malformations
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Being tested
- MAG-DHA, Oleic acid
- Keywords
- Pro-omega-3, Inflammation, Prematurity
- Medical subject headings
- Preterm Premature Rupture of the Membranes, Inflammation, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAG-DHADietary supplement
Also called Pro-omega-3
375 MG of MAG-DHA per capsules, two capsules BID
Oleic acidDietary supplement
Also called Sunflower oil
375 MG of sunflower oil (oleic acid) per capsules, two capsules BID
| Study group | Role | What they receive |
|---|---|---|
| MAG-DHA | Experimental | 1500 MG of MAG-DHA per day until childbirth or for up to 2 weeks Receives: Dietary Supplement: MAG-DHA |
| Placebo | Placebo comparator | 1500 MG of oleic acid per day until childbirth or for up to 2 weeks Receives: Dietary Supplement: Oleic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration latency period
Measured: From PPROM through delivery
Secondary outcomes (2)
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
Measured: From birth through the first 28 days of life
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
Measured: Every 2-3 days from PPROM until delivery or a maximum of 14 days, whichever happens first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start3 Dec 2018 (estimated)
- Primary completion5 Nov 2019 (estimated)
- Study completion15 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PPROMStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Laval University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739463
- Sponsor's protocol ID
- MP-31-2018-2496
- Acronym
- Pro-MEGA
- Status last verified
- Oct 2018
- First submitted
- 22 Oct 2018
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pro-omega-3, Reduction of Inflammation and Modulation of Prematurity
- ClinicalTrials.gov ID
- NCT03739463
- Acronym / sponsor ID
- Pro-MEGA / MP-31-2018-2496
- Conditions
- PPROM
- Keywords
- Pro-omega-3, Inflammation, Prematurity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Laval University
- Study start
- 3 Dec 2018 (estimated)
- Primary completion
- 5 Nov 2019 (estimated)
- Study completion
- 15 May 2020 (estimated)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAG-DHA | Experimental | Dietary Supplement: MAG-DHA1500 MG of MAG-DHA per day until childbirth or for up to 2 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Oleic acid1500 MG of oleic acid per day until childbirth or for up to 2 weeks |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- PPROM diagnosis, gestational age between 24 and 33 weeks of gestation.
Key exclusion criteria (1 listed)
- multiple pregnancy, placenta previa, preeclampsia, retroplacental hematoma, chorioamnionitis, intrauterine growth retardation, severe fetal malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAG-DHAAlso: Pro-omega-3375 MG of MAG-DHA per capsules, two capsules BID | Dietary supplement | MAG-DHA |
| Oleic acidAlso: Sunflower oil375 MG of sunflower oil (oleic acid) per capsules, two capsules BID | Dietary supplement | Placebo |
Primary outcome
Duration latency period
Time frame: From PPROM through delivery
2 secondary outcomes
Composite neonatal score
Time frame: From birth through the first 28 days of life
Inflammatory status
Time frame: Every 2-3 days from PPROM until delivery or a maximum of 14 days, whichever happens first
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing MAG-DHA and Oleic acid in people with PPROM, run by Université de Sherbrooke.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric Rousseau, PhD (819-346-1110 ext. 75306, eric-rousseau@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration latency period (time frame: From PPROM through delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.