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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04536753
Enrollment
845
Registered
2020-09-03
Start date
2018-01-01
Completion date
2018-12-31
Last updated
2020-10-05

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

Conditions

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

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.

Interventions

PROCEDUREInduction of labour

Induction of labour using amniotomy, vaginal prostaglandin administration and syntocinon in combination as per protocol.

Sponsors

Newcastle University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Birthweightthrough study completion, an average of 1 yearNeonatal weight as taken following delivery
Mode of deliverythrough study completion, an average of 1 yearCaesarean section and assisted delivery rates
Shoulder dystocia ratethrough study completion, an average of 1 yearAny clinically diagnosed cases of shoulder dystocia where the shoulders did not deliver with routine axial traction on the next contraction after the head was delivered.
Estimated blood lossthrough study completion, an average of 1 yearBlood loss as estimated by the clinical team
Obstetric Anal Sphincter Injurythrough study completion, an average of 1 yearAny tear involving the external anal sphincter and/or rectal mucosa
Admission to special care baby unit (SCBU)through study completion, an average of 1 yearAdmission of neonate to neonatal unit from labour ward
Epidural ratethrough study completion, an average of 1 yearUse of epdiural analgesia intrapartum

Other

MeasureTime frameDescription
Birthweight centile as per customised chartthrough study completion, an average of 1 yearBirthweight centile given birthweight and maternal characteristics as per perinatal institute
Birthweight centile as per WHO population chartthrough study completion, an average of 1 yearBased on Kiserud T, Piaggio G, Carroli G, Widmer M, Carvalho J, et al. (2017) The World Health Organization Fetal Growth Charts: A Multinational Longitudinal Study of Ultrasound Biometric Measurements and Estimated Fetal Weight. PLOS Medicine 14(1): e1002220. https://doi.org/10.1371/journal.pmed.1002220
Scan error as a percentage of estimated fetal weightthrough study completion, an average of 1 yearDifference between birthweight and what it was expected to be based on estimated weight (using perinatal institutes calculator) at scan, given as a percentage of that estimated weight
Prediction of Customised growth chart birthweight >90th centile by estimated weight on scanthrough study completion, an average of 1 yearAs above
Prediction of birthweight >4kg based on projected weight at time of delivery from scan estimated weightthrough study completion, an average of 1 yearAs above
Prediction of WHO birthweight >90th centile by scan estimated weight centile on WHO chartthrough study completion, an average of 1 yearAs above

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026