Condition category
Pregnancy and Childbirth
Date applied
13/06/2011
Date assigned
02/09/2011
Last edited
26/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The aim of this study is to determine whether providing women with high-risk pregnancies (i.e., with diabetes or at risk of low birth weight) with fish oil supplementation affects the magnetic resonance imaging (MRI) brain findings and development of their infants.

Who can participate?
Pregnant women with high-risk pregnancies with a known or recent diagnosis of diabetes or those at risk of delivering a low birth weight baby.

What does the study involve?
Participants will be randomly allocated to one of two groups. One group will receive fish oil supplements and the other group will receive olive oil, which is known to have health benefits from reports on the Mediterranean diet and longevity. Both groups will receive their routine antenatal care. The mothers will provide blood samples for testing of lipid (fat) profiles and iron status, and will complete questionnaires. The infants born to the mothers in the study groups will also be followed up for assessments including weight, length and head circumference. Cord blood will be taken at delivery to determine their blood lipid levels and stool samples will be obtained. The infants will undergo a brain MRI scan. Visual attention will be determined at each visit and a formal visual test will be undertaken at 9 months of age

What are the possible benefits and risks of participating?
Fish oil supplementation may result in improvement of the lipid profile of mothers and their babies.

Where is the study run from?
Imperial College (UK).

When is study starting and how long is it expected to run for?
The study will run from April 2010 to March 2013.

Who is funding the study?
Mother and Child Foundation (UK).

Who is the main contact?
Dr Enitan Ogundipe
e.ogundipe@imperial.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Enitan Ogundipe

ORCID ID

Contact details

Neonatal Unit
Chelsea & Westmsinster Hospital
Imperial College
369 Fulham Road
London
SW10 9NH
United Kingdom
+44 (0)20 3315 3326
e.ogundipe@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Maternal Fish Oil Supplementation in high risk pregnancies and the effect on the infants' brain MRI findings and neurobehavioural outcomes

Acronym

FOSS study

Study hypothesis

To determine whether maternal fish oil supplementation in women with high risk pregnancies, i.e.diabetes and risk of low birthweight affects the MRI bain findings and developmental outcomes of their infants

We postulate that high risk mothers and their fetuses will have lower docosahexaenoic acid (DHA) (in fish oil) levels than controls. Maternal supplementation with fish oil will result in improvement of the lipid profile of mothers and their fetuses. The un-supplemented group of infants will have lower grey matter and total brain volumes on MRI scans which will correlate to the neuro-developmental test scores.

Aims:
To determine whether lipid profiles and markers of oxidative stress differ between pregnant mothers supplemented with fish oils and those who are not, and if there is a relationship to their infantsÂ’ Brain MRI findings.
2. To determine whether supplementing pregnant and lactating high risk mothers with omega 3 affects the maternal psycho-behavioural outcomes
3. To determine whether supplementing pregnant mothers affects the infant postnatal morbidity, stool microflora, growth and neuro-developmental outcome.

Ethics approval

Not provided at time of registration

Study design

Double blind randomised placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Maternal diabetes mellitus, pre-eclampsia, low birthweight

Intervention

1. Fish oil supplements or placebo
2. MRI infant brain scan
3. Neuro-behavioural assessments of mother and infants

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Infants MRI brain scan findings
2. Maternal lipid profile

Secondary outcome measures

1. Infant developmental outcomes
2. Maternal neurobehavioural outcomes

Overall trial start date

01/04/2010

Overall trial end date

31/03/2013

Reason abandoned

Eligibility

Participant inclusion criteria

All pregnant women in high risk pregnancies with known or recent diagnosis of diabetes mellitus or those at risk of delivering a low birthweight baby cared for at the Chelsea & Westminster Hospital, London United Kingdom

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

300 pregnant women and their infants

Participant exclusion criteria

1. Fish allergy
2. Inability to speak english and refusal to use an interpreter
3. Non-resident in London
4. Unable to attend the follow up appointments

Recruitment start date

01/04/2010

Recruitment end date

31/03/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Neonatal Unit, Chelsea & Westmsinster Hospital
London
SW10 9NH
United Kingdom

Sponsor information

Organisation

Mother and Child Foundation (UK)

Sponsor details

36 Regents Park Road
London
NW1 7SX
United Kingdom

Sponsor type

Charity

Website

http://www.mother-and-child.org

Funders

Funder type

Charity

Funder name

Mother and Child Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

26/08/2016: No publications found, verifying study status with principal investigator