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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: Induction of labour


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 |