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

NCT ID: NCT04536753

Last Updated: 2020-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

845 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-12-31

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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Suspected large for gestational age (LGA)

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.

Induction of labour

Intervention Type PROCEDURE

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

Women with diabetes (DM)

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.

Induction of labour

Intervention Type PROCEDURE

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

Control

All other women induced at or after 280 days of gestation

Induction of labour

Intervention Type PROCEDURE

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

Interventions

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Induction of labour

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

Intervention Type PROCEDURE

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.

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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Newcastle University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Benjamin Simpson

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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SIMPS01

Identifier Type: -

Identifier Source: org_study_id

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