New Ultrasound Parameters for Predicting Birthweight

NCT ID: NCT02196363

Last Updated: 2018-12-04

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

253 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2015-07-31

Brief Summary

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Babies that are either very small or very big have increased perinatal morbidity and mortality. Predicting which babies will fall into these groups is traditionally done with risk assessment and third trimester manual palpation, however neither of these techniques are sensitive and a considerable number of affected pregnancies are missed. This results in stillbirth for small babies or birth trauma for larger ones. Serial scanning in the third trimester can improve detection rates but this is expensive and cannot currently be provided to all NHS patients.

A more sensitive test that can be performed earlier in pregnancy would allow identification of at risk pregnancies allowing for increased monitoring. New three dimensional ultrasound techniques that measure volume and volumetric flow have become available that may allow this to happen. This study proposes to trial newer ultrasound techniques on a cohort of pregnant women. The findings from these scans will then be correlated with actual birth weights at the end of pregnancy to determine the ability of these parameters to act as screening tools for babies at the extremes of size.

Detailed Description

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Conditions

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Fetal Development

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant mothers

No intervention

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Pregnant women the beginning of pregnancy to term

Exclusion Criteria

* Pregnancies in women previously affected by unclassfied fetal abnormality
* Multiple pregnancy
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ed Johnstone, MBChB PhD MRCOG

Role: PRINCIPAL_INVESTIGATOR

CMFT

Locations

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Central Manchester University Hospitals NHS Foundation Trust

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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10/H1013/9

Identifier Type: -

Identifier Source: org_study_id

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