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临床试验/NCT04536753
NCT04536753已完成不适用

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

Newcastle University1 个研究点 分布在 1 个国家目标入组 845 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
845
试验地点
1
主要终点
Mode of delivery

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Mode of delivery

时间窗: through study completion, an average of 1 year

Caesarean section and assisted delivery rates

Shoulder dystocia rate

时间窗: 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

时间窗: through study completion, an average of 1 year

Blood loss as estimated by the clinical team

Obstetric Anal Sphincter Injury

时间窗: 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)

时间窗: through study completion, an average of 1 year

Admission of neonate to neonatal unit from labour ward

Epidural rate

时间窗: through study completion, an average of 1 year

Use of epdiural analgesia intrapartum

Birthweight

时间窗: through study completion, an average of 1 year

Neonatal weight as taken following delivery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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