The Utility of Customised Growth Charts for Identifying Macrosomia and the Effect of Intervention
NCT ID: NCT04536753
Last Updated: 2020-10-05
Study Results
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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COMPLETED
845 participants
OBSERVATIONAL
2018-01-01
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
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
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
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.
Eligibility Criteria
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Inclusion Criteria
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
* Cases of induction for suspected LGA are to be excluded if there is a co-indication of obstetric cholestasis, hypertensive disorder or diabetes.
FEMALE
No
Sponsors
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Newcastle University
OTHER
Responsible Party
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Locations
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Benjamin Simpson
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Countries
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Other Identifiers
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SIMPS01
Identifier Type: -
Identifier Source: org_study_id
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