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

Sponsor
Newcastle University (Other)
Overall Status
Completed
CT.gov ID
NCT04536753
Collaborator
(none)
845
1
12
70.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
845 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Utility of Customised Growth Charts for Identifying Macrosomia and the Effect of Intervention
Actual Study Start Date :
Jan 1, 2018
Actual Primary Completion Date :
Dec 31, 2018
Actual Study Completion Date :
Dec 31, 2018

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Mode of delivery [through study completion, an average of 1 year]

    Caesarean section and assisted delivery rates

  2. Shoulder dystocia rate [through study completion, an average of 1 year]

    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.

  3. Estimated blood loss [through study completion, an average of 1 year]

    Blood loss as estimated by the clinical team

  4. Obstetric Anal Sphincter Injury [through study completion, an average of 1 year]

    Any tear involving the external anal sphincter and/or rectal mucosa

  5. Admission to special care baby unit (SCBU) [through study completion, an average of 1 year]

    Admission of neonate to neonatal unit from labour ward

  6. Epidural rate [through study completion, an average of 1 year]

    Use of epdiural analgesia intrapartum

  7. Birthweight [through study completion, an average of 1 year]

    Neonatal weight as taken following delivery

Other Outcome Measures

  1. Prediction of WHO birthweight >90th centile by scan estimated weight centile on WHO chart [through study completion, an average of 1 year]

    As above

  2. Birthweight centile as per customised chart [through study completion, an average of 1 year]

    Birthweight centile given birthweight and maternal characteristics as per perinatal institute

  3. Birthweight centile as per WHO population chart [through study completion, an average of 1 year]

    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

  4. Scan error as a percentage of estimated fetal weight [through study completion, an average of 1 year]

    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

  5. Prediction of Customised growth chart birthweight >90th centile by estimated weight on scan [through study completion, an average of 1 year]

    As above

  6. Prediction of birthweight >4kg based on projected weight at time of delivery from scan estimated weight [through study completion, an average of 1 year]

    As above

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Benjamin Simpson Newcastle Upon Tyne Tyne And Wear United Kingdom NE24HH

Sponsors and Collaborators

  • Newcastle University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Newcastle University
ClinicalTrials.gov Identifier:
NCT04536753
Other Study ID Numbers:
  • SIMPS01
First Posted:
Sep 3, 2020
Last Update Posted:
Oct 5, 2020
Last Verified:
Jul 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 5, 2020