The Utility of Customised Growth Charts for Identifying Macrosomia and the Effect of Intervention

N

Newcastle University

Status

Completed

Conditions

Induction of Labor Affected Fetus / Newborn
Fetal Growth Complications
Obstetric Complication
Ultrasound

Treatments

Procedure: Induction of labour

Study type

Observational

Funder types

Other

Identifiers

NCT04536753
SIMPS01

Details and patient eligibility

About

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.

Full 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.

Enrollment

845 patients

Sex

Female

Volunteers

No Healthy Volunteers

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.

Trial design

845 participants in 3 patient groups

Suspected large for gestational age (LGA)
Description:
Women with pregnancies suspected to be complicated by fetuses weighing more than the 90th centile on customised growth chart and induced for this reason prior to 287 days as the main indication without diabetes.
Treatment:
Procedure: Induction of labour
Women with diabetes (DM)
Description:
Women with diabetes in pregnancy induced at between 259 and 266 days if on treatment and 273 days if gestational diabetes managed with diet alone.
Treatment:
Procedure: Induction of labour
Control
Description:
All other women induced at or after 280 days of gestation
Treatment:
Procedure: Induction of labour

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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