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Completed

NCT Number: NCT04536753

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.

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Key information

Conditions

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

Sex eligibility

Female

Study type

Observational

Primary location

Benjamin Simpson

Newcastle upon Tyne, Tyne and Wear, NE24HH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

induction of labour

Procedure

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

Primary outcomes

  1. Mode of delivery

    Time frame: through study completion, an average of 1 year

    Caesarean section and assisted delivery rates

  2. Shoulder dystocia rate

    Time frame: 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

    Time frame: through study completion, an average of 1 year

    Blood loss as estimated by the clinical team

  4. Obstetric Anal Sphincter Injury

    Time frame: 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)

    Time frame: through study completion, an average of 1 year

    Admission of neonate to neonatal unit from labour ward

  6. Epidural rate

    Time frame: through study completion, an average of 1 year

    Use of epdiural analgesia intrapartum

  7. Birthweight

    Time frame: through study completion, an average of 1 year

    Neonatal weight as taken following delivery

Other outcomes

  1. Prediction of WHO birthweight >90th centile by scan estimated weight centile on WHO chart

    Time frame: through study completion, an average of 1 year

    As above

  2. Birthweight centile as per customised chart

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: through study completion, an average of 1 year

    As above

Sponsors and collaborators

Lead sponsor

Newcastle University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 3, 2020
Registry last updated
Oct 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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