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A comparison of low glycaemic index carbohydrate diet versus no dietary intervention in pregnancy to prevent recurrence of a large baby

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN54392969
Enrollment
700
Registered
2009-08-10
Start date
2007-01-01
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foetal macrosomia Pregnancy and Childbirth Disorders related to long gestation and high birth weight

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
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

Sponsors

Health Research Board (HRB) (Ireland)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Mean birth weight centiles and ponderal indices in each group, measured at 14 weeks, 28 weeks, 34 weeks, at birth and 3 months post-partum

Secondary

MeasureTime frame
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
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

Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 25, 2026