NCT03739463

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 13, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

December 3, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2020

Completed
Last Updated

November 20, 2018

Status Verified

October 1, 2018

Enrollment Period

11 months

First QC Date

October 22, 2018

Last Update Submit

November 19, 2018

Conditions

PPROM

Keywords

Pro-omega-3InflammationPrematurity

Outcome Measures

Primary Outcomes (1)

  • Duration latency period

    From PPROM through delivery

Secondary Outcomes (2)

  • Composite neonatal score

    From birth through the first 28 days of life

  • Inflammatory status

    Every 2-3 days from PPROM until delivery or a maximum of 14 days, whichever happens first

Study Arms (2)

MAG-DHA

EXPERIMENTAL

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

Dietary Supplement: MAG-DHA

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Oleic acid

Interventions

MAG-DHADIETARY_SUPPLEMENT

375 MG of MAG-DHA per capsules, two capsules BID

Also known as: Pro-omega-3
MAG-DHA
Oleic acidDIETARY_SUPPLEMENT

375 MG of sunflower oil (oleic acid) per capsules, two capsules BID

Also known as: Sunflower oil
Placebo

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnacy required
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • PPROM diagnosis, gestational age between 24 and 33 weeks of gestation.

You may not qualify if:

  • multiple pregnancy, placenta previa, preeclampsia, retroplacental hematoma, chorioamnionitis, intrauterine growth retardation, severe fetal malformations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Preterm Premature Rupture of the MembranesInflammationPremature Birth

Interventions

docosahexaenoic acid monoacylglycerideOleic AcidSunflower Oil

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Oleic AcidsFatty Acids, MonounsaturatedFatty Acids, UnsaturatedFatty AcidsLipidsPlant OilsPlant PreparationsBiological ProductsComplex Mixtures

Central Study Contacts

Eric Rousseau, PhD

CONTACT

819-346-1110eric-rousseau@usherbrooke.ca

Marie-Belle Poirier, PhD

CONTACT

8193461110Marie-Belle.Poirier@USherbrooke.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2018

First Posted

November 13, 2018

Study Start

December 3, 2018

Primary Completion

November 5, 2019

Study Completion

May 15, 2020

Last Updated

November 20, 2018

Record last verified: 2018-10