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Clinical Trials/NCT04536753
NCT04536753
Completed
Not Applicable

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

Newcastle University1 site in 1 country845 target enrollmentJanuary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstetric Complication
Sponsor
Newcastle University
Enrollment
845
Locations
1
Primary Endpoint
Mode of delivery
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
December 31, 2018
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Induced labour of a singleton pregnancy at Northumbria Healthcare Foundation trust resulting in a delivery between 01/01/2018 and 31/12/
  • 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 ng
  • 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.

Outcomes

Primary Outcomes

Mode of delivery

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

Caesarean section and assisted delivery rates

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.

Estimated blood loss

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

Blood loss as estimated by the clinical team

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

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

Epidural rate

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

Use of epdiural analgesia intrapartum

Birthweight

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

Neonatal weight as taken following delivery

Study Sites (1)

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