Improving detection of small infants during pregnancy

The DESiGN Trial: Detection of small for gestational age fetus (SGA) – a cluster randomised controlled trial to evaluate the effect of the Growth Assessment Protocol (GAP) programme

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN67698474

Enrollment

108

Registered

2016-11-02

Start date

2016-12-01

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Specialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive and sexual medicine Pregnancy and Childbirth Stillbirth

Interventions

Hospitals will be randomized to one of two groups. The method of allocation is the random permutation of clusters within each of two equally sized strata

clusters are divided in the two strata according to their size (deliveries per year in 2013-2014) and then randomized to either early or delayed implementation. Early implementation arm: The GAP pr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Hospitals: 1. Willing to implement GAP 2. Willing to participate in the trial Patients: 1. Pregnant women 2. Delivering at one of the participating hospitals during the study period

Exclusion criteria

Exclusion criteria: Hospitals that have fully implemented or will not be introducing GAP.

Design outcomes

Primary

Measure	Time frame
Detection rate of SGA infants measured by ultrasound after 24 weeks* is assessed using data from the maternity and ultrasound system between months 13 to 18 of study. * The antenatal charts used for ultrasound detection (numerator) will depend on the allocation arm of the trial. The denominator for the estimation of detection in each arm of the trial will be the same population of SGA infants (birthweight <10th centile) by both customised and population	—

Measure

Time frame

Detection rate of SGA infants measured by ultrasound after 24 weeks* is assessed using data from the maternity and ultrasound system between months 13 to 18 of study. * The antenatal charts used for ultrasound detection (numerator) will depend on the allocation arm of the trial. The denominator for the estimation of detection in each arm of the trial will be the same population of SGA infants (birthweight <10th centile) by both customised and population

—

Secondary

Measure	Time frame
1. Detection rate (sensitivity), specificity, false positive and false negative of SGA by customised centiles measured by ultrasound after 24 weeks 2. Detection rate (sensitivity), specificity, false positive and false negative of SGA by population centiles measured by ultrasound after 24 weeks Clinical outcomes: Neonatal: 1. Gestational age measured in weeks at birth 2. Birthweight measured in grams at birth 3. Head circumference measured in centimeters at birth 4. Apgar score 28 days, necrotizing enterocolitis, sepsis, retinopathy of prematurity 11. Length of stay in transitional care measured in days 12. Rate of neonatal morbidity defined as one or more of the following: hypothermia, hypoglycaemia, nasogastric tube feeding 13. Rate or stillbirth (antepartum and intrapartum) 14. Rate of neonatal death (early and late) 15. Rate of neonatal death before discharge (after 28 days of birth) Maternal: 1. Rate of induction of labour measured at birth 2. Rate of caesarean section measured at birth 3. Rates of postpartum haemorrhage (>1000ml) measured at birth 4. Rate of severe perineal trauma (3rd / 4th degree tear) measured at birth 5. Length of stay in hospital measured in days 6. Method of breast feeding measured at discharge Health economics outcomes: 1. Number of ultrasound scans after 24 weeks measured at delivery (as average of ultrasound per women) 2. Number of antenatal clinic / antenatal day unit measured at delivery (as average of ultrasound per women) Process evaluation of implementation outcomes: 1. Proportion of staff trained measured at the end of training period (expected to be at month 6 of study) 2. Proportion of staff assessed for GAP training at the end of training period (expected to be at month 6 of study) 3. Proportion of women assessed with GAP programme measured throughout the study by review of notes of a sample of participants 4. Adherence to SGA risk stratification and management protocols and missed case analysis measured throughout the	—

Measure

Time frame

1. Detection rate (sensitivity), specificity, false positive and false negative of SGA by customised centiles measured by ultrasound after 24 weeks 2. Detection rate (sensitivity), specificity, false positive and false negative of SGA by population centiles measured by ultrasound after 24 weeks Clinical outcomes: Neonatal: 1. Gestational age measured in weeks at birth 2. Birthweight measured in grams at birth 3. Head circumference measured in centimeters at birth 4. Apgar score 28 days, necrotizing enterocolitis, sepsis, retinopathy of prematurity 11. Length of stay in transitional care measured in days 12. Rate of neonatal morbidity defined as one or more of the following: hypothermia, hypoglycaemia, nasogastric tube feeding 13. Rate or stillbirth (antepartum and intrapartum) 14. Rate of neonatal death (early and late) 15. Rate of neonatal death before discharge (after 28 days of birth) Maternal: 1. Rate of induction of labour measured at birth 2. Rate of caesarean section measured at birth 3. Rates of postpartum haemorrhage (>1000ml) measured at birth 4. Rate of severe perineal trauma (3rd / 4th degree tear) measured at birth 5. Length of stay in hospital measured in days 6. Method of breast feeding measured at discharge Health economics outcomes: 1. Number of ultrasound scans after 24 weeks measured at delivery (as average of ultrasound per women) 2. Number of antenatal clinic / antenatal day unit measured at delivery (as average of ultrasound per women) Process evaluation of implementation outcomes: 1. Proportion of staff trained measured at the end of training period (expected to be at month 6 of study) 2. Proportion of staff assessed for GAP training at the end of training period (expected to be at month 6 of study) 3. Proportion of women assessed with GAP programme measured throughout the study by review of notes of a sample of participants 4. Adherence to SGA risk stratification and management protocols and missed case analysis measured throughout the

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 12, 2026