Condition category
Pregnancy and Childbirth
Date applied
22/04/2009
Date assigned
10/08/2009
Last edited
04/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Fionnuala McAuliffe

ORCID ID

Contact details

UCD Obstetrics & Gynaecology
UCD School of Medicine and Medical Science
University College Dublin
National Maternity Hospital
Holles Street
Dublin
2
Ireland
+353 (0)1 637 3216/3296
fmcauliffe@nmh.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled trial of low glycaemic index carbohydrate diet versus no dietary intervention in the prevention of recurrence of foetal macrosomia

Acronym

Study hypothesis

As of 01/09/2009 this record was updated to include an amended protocol; all changes can be found in the relevant section under the above update date.

Current information as of 01/09/2009:
1. Amongst women at risk of a macrosomic baby, a low glycaemic index diet in pregnancy is associated with reduction in birth weight centiles when compared to no dietary intervention
2. Amongst women at risk of a macrosomic baby, a low glycaemic index diet in pregnancy is associated with less maternal weight gain compared to no dietary intervention

Initial information at time of registration:
1. Amongst women at risk of a macrosomic baby, a low glycaemic index diet in pregnancy is associated with reduction in birth weight centiles when compared to no dietary intervention
2. Amongst women at risk of a macrosomic baby, a low glycaemic index diet in pregnancy is associated with less maternal weight gain compared to no dietary intervention
3. A low glycaemic index diet in pregnancy when compared to no dietary intervention is associated with differences in urinary metabolomics
4. A low glycaemic index diet in pregnancy when compared to no dietary intervention is associated with differences in cord leptin, insulin-like growth factor 1 (IGF-1) and insulin
5. A low glycaemic index diet in pregnancy when compared to no dietary intervention is associated with differences in placental villous and vascular development

Ethics approval

Ethics Committee at the National Maternity Hospital gave approval in June 2006

Study design

Randomised 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

Foetal macrosomia

Intervention

Methods:
Women choosing to enter the study will give written informed consent. Data will be collected on those women approached for study participation and who declined to ensure those participating are representative of this entire group.

Patients will be randomised into two arms: a control arm which will receive no dietary intervention during pregnancy and a diet arm which will be commenced on a low glycaemic index diet from 14 weeks gestation to delivery under dietetic supervision. Each patient in the diet arm will receive an individualised diet which will be energy matched as appropriate to a patients' average caloric intake with the aim of reducing glycaemic load and glycaemic excursions. This diet is eucaloric and is not designed to promote weight loss. In the diet arm, the aim for weight gain during pregnancy will be a 8 - 10 kg for a woman of normal weight and 5 - 7 kg in women with weight greater than 100 kg. In the diet arm each patient will have one dietetic session, in groups of 4 - 6 at 12 - 16 weeks gestation, with the aim of commencing the diet at 16 weeks gestation.

At booking visit all patients will have their height and weight recorded and their BMI will be calculated (maternal weight [kg]/height [m^2]). Additional demographic data including smoking history, socio-economic group (SEG) and paternal weight and height will be recorded.

In addition to routine care the following additional tests will be performed:
1. Food frequency questionnaire at 12, 28 weeks gestation and 3 months post-partum. Average weekly exercise will also be recorded as part of this questionnaire. The food questionnaire will use questions from section I of the 'SLAN (Survey of Lifestyle, Attitudes and Nutrition) National Health and Lifestyle Survey' 2002. This has been validated in an Irish population. At 3 months postpartum the questionnaire will assess compliance to the low glycaemic index diet following pregnancy. Information at 12 weeks will allow baseline information to be obtained. Assessment at 28 weeks gestation will assess compliance to the diet in the intervention arm.
2. At each visit maternal weight will be recorded: 12, 20, 28, 34, 36, 38, 40 weeks' gestation
3. At 12 weeks fasting blood glucose [and insulin, leptin and IGF-1 - removed 01/09/2009], mid upper arm circumference and body mass index will be taken. [This will assess baseline insulin resistance and glucose status. Assessment of leptin and IGF-1 will allow comparison between foetal and neonatal size and maternal growth factors - removed 01/09/2009]
[4. Urine analysis for nitrogen and metabolomic profile. This will assess the effect of diet on metabolism as one may expect protein and kreb cycle products to differ between the groups. Urinary nitrogen measurement will be an indicator of protein breakdown for energy substrate - removed 01/09/2009]
5. Glucose challenge test at 28 weeks. It is important to determine the presence of gestational diabetes in this group. If gestational diabetes is present care will continue in the multidisciplinary diabetic clinic.
6. Foetal growth ultrasound at 34 weeks. Foetal biometry including anterior abdominal wall thickness will be measured to ensure normal foetal growth velocity and for comparison to the birth weight.
[7. At the 34 week scan, patients in the diet group will be asked to complete a simple questionnaire comprising 5 questions to determine compliance with diet
8. Cord bloods for insulin, leptin and IGF-1. These will be correlated with maternal growth factors, maternal and foetal weight.
9. Placental biopsy for assessment of placental architecture. A placental sample will be retained in both arms of the study for later analysis to determine if there is a relationship between placental villous and vascular morphology and recurrence of macrosomia - removed 01/09/2009]
10. Neonatal anthropometry. At delivery, infant birth weight, infant length and head circumference will be recorded in all cases as is current routine practice. [The ponderal index will be computed - removed 01/09/2009]

Randomisation:
This will be achieved using computer generated allocations in a ratio of 1:1 contained in sealed opaque envelopes.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Mean birth weight centiles and ponderal indices in each group. Outcomes will be measured at 14 weeks, 28 weeks, 34 weeks, at birth and 3 months post-partum.

Secondary outcome measures

Current information as of 01/09/2009:
Differences between the two groups in maternal weight gain in pregnancy, measured at 14 weeks, 28 weeks, 34 weeks, at birth and 3 months post-partum.

Initial information at time of registration:
Differences between the two groups:
1. Maternal weight gain in pregnancy
2. Urinary metabolomics
3. Cord insulin, leptin and IGF-1
4. Placental weight, villous and vascular development
Outcomes will be measured at 14 weeks, 28 weeks, 34 weeks, at birth and 3 months post-partum.

Overall trial start date

01/01/2007

Overall trial end date

30/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Secundigravid women of reproductive age (greater than 18 years and less than 45 years) whose first baby was macrosomic (birth weight greater than 4000 g) will be recruited at first booking visit from the antenatal clinic at the National Maternity Hospital.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

700 women

Participant exclusion criteria

1. Diabetes
2. Other medical disorders
[3. Weight greater than 120 kg - removed 01/09/2009]
4. Poor previous pregnancy outcome

Recruitment start date

01/01/2007

Recruitment end date

30/12/2009

Locations

Countries of recruitment

Ireland

Trial participating centre

UCD Obstetrics & Gynaecology
Dublin
2
Ireland

Sponsor information

Organisation

Health Research Board (HRB) (Ireland)

Sponsor details

73 Lower Baggot St
Dublin
2
Ireland
+353 (0)1 234 5000
hrb@hrb.ie

Sponsor type

Government

Website

http://www.hrb.ie

Funders

Funder type

Government

Funder name

Health Research Board (HRB) (Ireland)

Alternative name(s)

HRB

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Ireland

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

2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20416041
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24175958

Publication citations

  1. Protocol

    Walsh J, Mahony R, Foley M, Mc Auliffe F, A randomised control trial of low glycaemic index carbohydrate diet versus no dietary intervention in the prevention of recurrence of macrosomia., BMC Pregnancy Childbirth, 2010, 10, 16, doi: 10.1186/1471-2393-10-16.

  2. Results

    McGowan CA, Walsh JM, Byrne J, Curran S, McAuliffe FM, The influence of a low glycemic index dietary intervention on maternal dietary intake, glycemic index and gestational weight gain during pregnancy: a randomized controlled trial., Nutr J, 2013, 12, 1, 140, doi: 10.1186/1475-2891-12-140.

Additional files

Editorial Notes