The Utility of Customised Growth Charts for Identifying Macrosomia and the Effect of Intervention
- Conditions
- UltrasoundObstetric ComplicationFetal Growth ComplicationsInduction of Labor Affected Fetus / Newborn
- Interventions
- Procedure: Induction of labour
- Registration Number
- NCT04536753
- Lead Sponsor
- Newcastle University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 845
- 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
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control Induction of labour All other women induced at or after 280 days of gestation Suspected large for gestational age (LGA) Induction of labour 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. Women with diabetes (DM) Induction of labour 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.
- Primary Outcome Measures
Name Time Method Mode of delivery through study completion, an average of 1 year Caesarean section and assisted delivery rates
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.
Estimated blood loss through study completion, an average of 1 year Blood loss as estimated by the clinical team
Obstetric Anal Sphincter Injury 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) through study completion, an average of 1 year Admission of neonate to neonatal unit from labour ward
Epidural rate through study completion, an average of 1 year Use of epdiural analgesia intrapartum
Birthweight through study completion, an average of 1 year Neonatal weight as taken following delivery
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Benjamin Simpson
🇬🇧Newcastle Upon Tyne, Tyne And Wear, United Kingdom