New Ultrasound Parameters for Predicting Birthweight

Fetal Development Clinical Trial

— NUPS  

Official title:

New Ultrasound Parameters for Predicting Birthweight

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02196363
• Other study ID #: 10/H1013/9
• Status: Completed
• Start date: July 2010
• Est. completion date: July 2015

Study information

• Verified date: November 2018
• Source: Manchester University NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: July 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnant women the beginning of pregnancy to term

Exclusion Criteria:

• Pregnancies in women previously affected by unclassfied fetal abnormality

• Multiple pregnancy

Related Conditions & MeSH terms

• Birth Weight
• Fetal Development

Locations

Country	Name	City	State
United Kingdom	Central Manchester University Hospitals NHS Foundation Trust	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kidney volume, thigh volume, placental volume, brain volume, final birthweight		up to 34-36 weeks pregnancy gestation