Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001123932
Ethics application status
Approved
Date submitted
21/10/2011
Date registered
27/10/2011
Date last updated
31/10/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect on birth outcomes of discussions in early pregnancy, emphasising the importance of eating fish.
Scientific title
The effect on birth outcomes, especially birthweight, head circumference and other indices of fetal wellbeing, of discussions with women attending a UK antenatal clinic at 20 weeks' pregnancy or less , during which the benefits of eating fish during pregnancy were emphasised.
Secondary ID [1] 273217 0
Nil
Universal Trial Number (UTN)
U1111-1125-2646
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Encouraging healthy pregnancy outcomes 278980 0
Condition category
Condition code
Reproductive Health and Childbirth 279155 279155 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One informal one-to-one discussion of 15 - 20 minutes, between the researcher and pregnant women at 20 or fewer weeks gestation, covering lifestyle and diet, in which the benefits of eating fish, especially oily fish, were emphasised. The interviewees were all attending antenatal clinic at a UK hospital for the first time in that pregnancy and had no apparent complications of this pregnancy to date. The intervention was in addition to the standard antenatal care offerd by the hospital clinic.
Intervention code [1] 269547 0
Lifestyle
Comparator / control treatment
Controls, identified by blind randomisation, received the standard antenatal care offered by the hospital clinic.
Control group
Active

Outcomes
Primary outcome [1] 279794 0
Percentage of babies with birthweight below 2500g.
Timepoint [1] 279794 0
After the last participant had given birth
Secondary outcome [1] 294443 0
Percentage of babies of 4200g or greater birthweight
Timepoint [1] 294443 0
After the last participant had given birth
Secondary outcome [2] 294444 0
Mean birthweight (g)
Timepoint [2] 294444 0
After the last participant had given birth
Secondary outcome [3] 294445 0
Mean head circumference (cms)
Timepoint [3] 294445 0
After the last participant had given birth. Head circumference was measured at birth by the attending midwife.
Secondary outcome [4] 294446 0
Mean body length (cms)
Timepoint [4] 294446 0
After the last participant had given birth. body length was measured at birth by the attending midwife.
Secondary outcome [5] 294447 0
Percentage of babies born under 37 weeks gestation
Timepoint [5] 294447 0
After the last participant had given birth
Secondary outcome [6] 294448 0
Mean birthweight adjusted for gestational age and gender
Timepoint [6] 294448 0
After the last participant had given birth
Secondary outcome [7] 294449 0
Mean head circumference adjusted for gestational age and gender
Timepoint [7] 294449 0
After the last participant had given birth
Secondary outcome [8] 294450 0
Percentage of babies with birthweight below 1500g
Timepoint [8] 294450 0
After the last participant had given birth

Eligibility
Key inclusion criteria
Women up to and including 20 weeks gestation, making their first visit to the antenatal clinic in their current pregnancy
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients under 18 years old unless accompained by a responsible adult who could sign consent
Epileptics
Women with a recent psychiatric history
Patients taking part in existing studies, where inclusion may adversely affect either project
Women with a poor obstetric or medical history
Known drug users
Non-English speaking women if a translator was not available

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The hospital files of pregnant women who were to make their first visit to the antenatal clinic at the hospital were checked by the researcher, and all eligible women were given information and consent forms by the antenatal clinic receptionists upon registration at the clinic reception desk. The researcher then approached these women individually and asked if they would take part in the study, if necessary reading the letter to them or providing further explanation. Women who did not wish to participate were thanked for reading the letter and were not made to feel uncomfortable about their refusal. Those who signed the consent forms were given a numbered, opaque envelope to open that contained a letter informing them that they were, or were not to be interviewed. Consent forms were noted with ‘intervention’ or ‘control’ and the number of the envelope, and were filed in the patients’ hospital notes.

Women allocated to the control group were thanked for their participation and assured that their baby’s birth details would be of importance to the study. The researcher explained to intervention group women that she would be talking to them about pregnancy and that she would find them after their ultrasound scans, while they were waiting to see the doctor. Women randomised to the intervention group were duly identified and collected from the waiting area of the antenatal clinic following ultrasound scans but before seeing the consultant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Women agreeing to participate were randomised either to standard antenatal care plus a discussion or to standard antenatal care only. Letters allocating women to either intervention (I) or control (C) groups were placed in opaque sealed envelopes by someone unconnected with the trial. The envelopes were numbered consecutively in accordance with lists of randomly created blocks of 5, using the throw of a die, producing allocation sequences such as ICICI or IICIC. The 3:2 randomisation was chosen to maximise the researchers' time for interviewing in clinic.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/1998
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2837
Accrual to date
Final
Recruitment outside Australia
Country [1] 3910 0
United Kingdom
State/province [1] 3910 0
West Midlands

Funding & Sponsors
Funding source category [1] 270042 0
Commercial sector/Industry
Name [1] 270042 0
The Seafish Industry Authority
Country [1] 270042 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
The Seafish Industry Authority
Address
Sea Fish Industry Authority.
Seafish House,
St Andrews Dock,
Hull
HU3 4QE
Country
United Kingdom
Secondary sponsor category [1] 269013 0
Charities/Societies/Foundations
Name [1] 269013 0
Primal Health Research Centre
Address [1] 269013 0
72 Savernake Road,
London
NW3 2JR
Country [1] 269013 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271996 0
Wolverhampton Health Authority
Wolverhampton District Research Ethics Committee
Ethics committee address [1] 271996 0
Merged - now:
West Midlands - Staffordshire NRES
Prospect House
Fishing Line Road
Enfield
Redditch
B97 6EW
Ethics committee country [1] 271996 0
United Kingdom
Date submitted for ethics approval [1] 271996 0
01/10/1997
Approval date [1] 271996 0
19/11/1997
Ethics approval number [1] 271996 0
Project 399

Summary
Brief summary
Research findings indicate that pregnant women should increase their intake of oily fish before, during and after pregnancy and that they should breastfeed. Despite this advice, no direct evidence exists that increased oily fish intake during pregnancy is beneficial to birth outcomes. In addition the possible effectiveness of personalised dietary advice given to women antenatally has been little-investigated. The nutritional advice approach differs from that of fish oil supplementation as eating fish is a dietary choice and oily fish may have effects differing from those of supplementation because of the many nutrients present in addition to omega-3 fatty acids.

In an study carried out at Whipps Cross Hospital by Dr Michel Odent a single discussion session was held at or before 20 weeks gestation, at which stage of pregnancy, the brain growth spurt and rapid endothelial growth begin, that focused on an increased intake of oily fish and a reduced intake of trans-fatty acids. Trends to greater birthweight, head circumference, body length and to a lower incidence of low birthweight were observed. Thus the effect of giving advice to pregnant women to increase intake of oily fish was sufficiently positive to indicate the value of further study. Controlled prospective studies exploring the effect of encouraging consumption of oily fish and a reduction in the intake of trans-fatty acids have not been carried out.

The benefits of improving maternal nutrition before and during pregnancy and throughout lactation are many. The health of the baby is dependent on maternal nutrition and there is evidence to suggest that small birth size is a major contributor to the cause of adult disease, including hypertension, coronary heart disease, type II diabetes and renal disease. Treating and caring for people with coronary heart disease costs Britain about £7billion each year, according to the British Heart Foundation, and the cost of caring for patients with type II diabetes is estimated by Diabetes UK to be £3.5billion annually. There are clear public health benefits in reducing the incidence of low birthweight and consequently the prevalence of these debilitating and costly diseases.
It is hypothesised that a one-to-one informal discussion with pregnant women before 20 weeks gestation, emphasising the benefits to mother and fetus of oily fish consumption, will result in improved birth outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33272 0
Address 33272 0
Country 33272 0
Phone 33272 0
Fax 33272 0
Email 33272 0
Contact person for public queries
Name 16519 0
Dr Lesley Meeson
Address 16519 0
University of Wolverhampton
Centre for Health and Social Care Improvement
ML Building
Deanery Row
Off Molineux street
Wolverhampton WV1 1DT
Country 16519 0
United Kingdom
Phone 16519 0
+44 (0) 1902 518631
Fax 16519 0
+44 (0) 1902 518600
Email 16519 0
[email protected]
Contact person for scientific queries
Name 7447 0
Dr Lesley Meeson
Address 7447 0
University of Wolverhampton
Centre for Health and Social Care Improvement
ML Building
Deanery Row
Off Molineux street
Wolverhampton WV1 1DT
Country 7447 0
United Kingdom
Phone 7447 0
+44 (0) 1902 518631
Fax 7447 0
+44 (0) 1902 518600
Email 7447 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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