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

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.

Study Overview

• Status: Completed
• Conditions: Ultrasound; Obstetric Complication; Induction of Labor Affected Fetus / Newborn; Fetal Growth Complications
• Intervention / Treatment: Procedure: Induction of labour

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.

• Study Type: Observational
• Enrollment (Actual): 845

Contacts and Locations

Study Locations

• United Kingdom
  • Tyne And Wear
    • Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE24HH
      • Benjamin Simpson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Suspected large for gestational age (LGA); 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.	Procedure: Induction of labour; Induction of labour using amniotomy, vaginal prostaglandin administration and syntocinon in combination as per protocol.
Women with diabetes (DM); 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.	Procedure: Induction of labour; Induction of labour using amniotomy, vaginal prostaglandin administration and syntocinon in combination as per protocol.
Control; All other women induced at or after 280 days of gestation	Procedure: Induction of labour; Induction of labour using amniotomy, vaginal prostaglandin administration and syntocinon in combination as per protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mode of delivery	Caesarean section and assisted delivery rates	through study completion, an average of 1 year
Shoulder dystocia rate	Any 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.	through study completion, an average of 1 year
Estimated blood loss	Blood loss as estimated by the clinical team	through study completion, an average of 1 year
Obstetric Anal Sphincter Injury	Any tear involving the external anal sphincter and/or rectal mucosa	through study completion, an average of 1 year
Admission to special care baby unit (SCBU)	Admission of neonate to neonatal unit from labour ward	through study completion, an average of 1 year
Epidural rate	Use of epdiural analgesia intrapartum	through study completion, an average of 1 year
Birthweight	Neonatal weight as taken following delivery	through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction of WHO birthweight >90th centile by scan estimated weight centile on WHO chart	As above	through study completion, an average of 1 year
Birthweight centile as per customised chart	Birthweight centile given birthweight and maternal characteristics as per perinatal institute	through study completion, an average of 1 year
Birthweight centile as per WHO population chart	Based 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	through study completion, an average of 1 year
Scan error as a percentage of estimated fetal weight	Difference 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	through study completion, an average of 1 year
Prediction of Customised growth chart birthweight >90th centile by estimated weight on scan	As above	through study completion, an average of 1 year
Prediction of birthweight >4kg based on projected weight at time of delivery from scan estimated weight	As above	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Newcastle University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): December 31, 2018
• Study Completion (ACTUAL): December 31, 2018

Study Registration Dates

• First Submitted: August 28, 2020
• First Submitted That Met QC Criteria: August 28, 2020
• First Posted (ACTUAL): September 3, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2020
• Last Update Submitted That Met QC Criteria: October 1, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: SIMPS01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No