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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]

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

Condition category

Condition code

Reproductive Health and Childbirth

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]

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]

Percentage of babies with birthweight below 2500g.

Timepoint [1]

After the last participant had given birth

Secondary outcome [1]

Percentage of babies of 4200g or greater birthweight

Timepoint [1]

After the last participant had given birth

Secondary outcome [2]

Mean birthweight (g)

Timepoint [2]

After the last participant had given birth

Secondary outcome [3]

Mean head circumference (cms)

Timepoint [3]

After the last participant had given birth. Head circumference was measured at birth by the attending midwife.

Secondary outcome [4]

Mean body length (cms)

Timepoint [4]

After the last participant had given birth. body length was measured at birth by the attending midwife.

Secondary outcome [5]

Percentage of babies born under 37 weeks gestation

Timepoint [5]

After the last participant had given birth

Secondary outcome [6]

Mean birthweight adjusted for gestational age and gender

Timepoint [6]

After the last participant had given birth

Secondary outcome [7]

Mean head circumference adjusted for gestational age and gender

Timepoint [7]

After the last participant had given birth

Secondary outcome [8]

Percentage of babies with birthweight below 1500g

Timepoint [8]

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]

United Kingdom

State/province [1]

West Midlands

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

The Seafish Industry Authority

Address [1]

Sea Fish Industry Authority.
Seafish House,
St Andrews Dock,
Hull
HU3 4QE

Country [1]

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]

Charities/Societies/Foundations

Name [1]

Primal Health Research Centre

Address [1]

72 Savernake Road,
London
NW3 2JR

Country [1]

United Kingdom

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Wolverhampton Health Authority
Wolverhampton District Research Ethics Committee

Ethics committee address [1]

Merged - now:
West Midlands - Staffordshire NRES
Prospect House
Fishing Line Road
Enfield
Redditch
B97 6EW

Ethics committee country [1]

United Kingdom

Date submitted for ethics approval [1]

01/10/1997

Approval date [1]

19/11/1997

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Lesley Meeson

Address

University of Wolverhampton
Centre for Health and Social Care Improvement
ML Building
Deanery Row
Off Molineux street
Wolverhampton WV1 1DT

Country

United Kingdom

Phone

+44 (0) 1902 518631

Fax

+44 (0) 1902 518600

[email protected]

Contact person for scientific queries

Name

Dr Lesley Meeson

Address

University of Wolverhampton
Centre for Health and Social Care Improvement
ML Building
Deanery Row
Off Molineux street
Wolverhampton WV1 1DT

Country

United Kingdom

Phone

+44 (0) 1902 518631

Fax

+44 (0) 1902 518600

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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