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

Ultrasound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04536753
• Other study ID #: SIMPS01
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2020
• Source: Newcastle University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 845
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Benjamin Simpson	Newcastle Upon Tyne	Tyne And Wear

Sponsors (1)

Lead Sponsor	Collaborator
Newcastle University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prediction of WHO birthweight >90th centile by scan estimated weight centile on WHO chart	As above	through study completion, an average of 1 year
Other	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
Other	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
Other	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
Other	Prediction of Customised growth chart birthweight >90th centile by estimated weight on scan	As above	through study completion, an average of 1 year
Other	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
Primary	Mode of delivery	Caesarean section and assisted delivery rates	through study completion, an average of 1 year
Primary	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
Primary	Estimated blood loss	Blood loss as estimated by the clinical team	through study completion, an average of 1 year
Primary	Obstetric Anal Sphincter Injury	Any tear involving the external anal sphincter and/or rectal mucosa	through study completion, an average of 1 year
Primary	Admission to special care baby unit (SCBU)	Admission of neonate to neonatal unit from labour ward	through study completion, an average of 1 year
Primary	Epidural rate	Use of epdiural analgesia intrapartum	through study completion, an average of 1 year
Primary	Birthweight	Neonatal weight as taken following delivery	through study completion, an average of 1 year