Clinical trial NCT04536753: The Utility of Customised Growth Charts for Identifying Macrosomia and the Effect of Intervention
Official title: The Utility of Customised Growth Charts for Identifying Macrosomia and the Effect of Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstetric Complication
Ultrasound
Induction of Labor Affected Fetus / Newborn
Fetal Growth Complications
Lead sponsor: Newcastle University
Sponsor class: OTHER
First posted: 2020-09-03
Enrollment: 845
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women booked for their care at Northumbria Healthcare Trust in North East England: a predominantly white British female population with rates of obesity above the national average.

Brief summary: Best management of suspected large for gestational age (LGA) fetuses is unclear. In some hospitals women with an LGA fetus by customised growth charts are are offered earlier induction. This study aimed to examine scan accuracy for this group and the outcome with intervention.

Detailed description: This is a retrospective cohort study of pregnant women taken from 3 groups; women with a suspected LGA fetus (LGA), women with diabetes (DM) and a control group of women that underwent induction of labour at or after 40 weeks. Scan accuracy using GROW and WHO charts in the LGA and DM cohorts was assessed using ROC curves and outcomes between the cohorts was compared.

Eligibility criteria: Inclusion Criteria:

* Induced labour of a singleton pregnancy at Northumbria Healthcare Foundation trust resulting in a delivery between 01/01/2018 and 31/12/2018.

Inclusion in the LGA group means that the main indication for induction is recorded as suspected macrosomia.

Inclusion in the Diabetic group means diabetes was pre-existing or arose in pregnancy, diagnosed by oral glucose tolerance testing from 24-30 weeks or by home blood glucose monitoring with standard thresholds as per NICE ng3. Induction had to be undertaken with diabetes as the (co)indication.

Inclusion criteria for the control group was induction of labour at or after 280 days gestation

Exclusion Criteria:

Previous caesarean section Multiple pregnancy Fetal concerns pre-induction: abnormal antenatal trace or abnormal doppler flow studies on antenatal ultrasound

* Cases of induction for suspected LGA are to be excluded if there is a co-indication of obstetric cholestasis, hypertensive disorder or diabetes.

Primary outcomes:
measure: Mode of delivery
timeFrame: through study completion, an average of 1 year
measure: Shoulder dystocia rate
timeFrame: through study completion, an average of 1 year
measure: Estimated blood loss
timeFrame: through study completion, an average of 1 year
measure: Obstetric Anal Sphincter Injury
timeFrame: through study completion, an average of 1 year
measure: Admission to special care baby unit (SCBU)
timeFrame: through study completion, an average of 1 year
measure: Epidural rate
timeFrame: through study completion, an average of 1 year
measure: Birthweight
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
measure: Prediction of WHO birthweight >90th centile by scan estimated weight centile on WHO chart
timeFrame: through study completion, an average of 1 year
measure: Birthweight centile as per customised chart
timeFrame: through study completion, an average of 1 year
measure: Birthweight centile as per WHO population chart
timeFrame: through study completion, an average of 1 year
measure: Scan error as a percentage of estimated fetal weight
timeFrame: through study completion, an average of 1 year
measure: Prediction of Customised growth chart birthweight >90th centile by estimated weight on scan
timeFrame: through study completion, an average of 1 year
measure: Prediction of birthweight >4kg based on projected weight at time of delivery from scan estimated weight
timeFrame: through study completion, an average of 1 year
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Benjamin Simpson
state: Tyne And Wear
Study officials:
References: