Welcome
Support Centre
23 September 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
A comparison of low glycaemic index carbohydrate diet versus no dietary intervention in pregnancy to prevent recurrence of a large baby
ISRCTN ISRCTN54392969
DOI 10.1186/ISRCTN54392969
ClinicalTrials.gov identifier
EudraCT number
Public title A comparison of low glycaemic index carbohydrate diet versus no dietary intervention in pregnancy to prevent recurrence of a large baby
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 N/A
Serial number at source N/A
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
Lay summary Not provided at time of registration
Ethics approval Ethics Committee at the National Maternity Hospital gave approval in June 2006
Study design Randomised controlled trial
Countries of recruitment Ireland
Disease/condition/study domain Foetal macrosomia
Participants - 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.
Participants - exclusion criteria 1. Diabetes
2. Other medical disorders
[3. Weight greater than 120 kg - removed 01/09/2009]
4. Poor previous pregnancy outcome
Anticipated start date 01/01/2007
Anticipated end date 30/12/2009
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 700 women
Interventions 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.
Primary outcome measure(s) 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 measure(s) 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.
Sources of funding Health Research Board (HRB) (Ireland)
Trial website
Publications 2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20416041
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24175958
Contact name Prof  Fionnuala  McAuliffe
  Address UCD Obstetrics & Gynaecology
UCD School of Medicine and Medical Science
University College Dublin
National Maternity Hospital
Holles Street
  City/town Dublin
  Zip/Postcode 2
  Country Ireland
  Tel +353 (0)1 637 3216/3296
  Fax +353 (0)1 676 6623
  Email fmcauliffe@nmh.ie
Sponsor Health Research Board (HRB) (Ireland)
  Address 73 Lower Baggot St
  City/town Dublin
  Zip/Postcode 2
  Country Ireland
  Tel +353 (0)1 234 5000
  Fax +353 (0)1 661 2335
  Email hrb@hrb.ie
  Sponsor website: http://www.hrb.ie
Date applied 22/04/2009
Last edited 04/11/2013
Date ISRCTN assigned 10/08/2009
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.