New Ultrasound Parameters for Predicting Birthweight

NCT02196363 | Completed

• 1 other identifier: 10/H1013/9
• Study Type: observational
• Target: 253
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fetal Development

Outcome Measures

Primary Outcomes (1)

• Kidney volume, thigh volume, placental volume, brain volume, final birthweight

  up to 34-36 weeks pregnancy gestation

Study Arms (1)

Pregnant mothers

No intervention

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be identified by screening booked scan appointments in regular antenatal clinics. The first approach will be by either the named local investigators

You may qualify if:

• Pregnant women the beginning of pregnancy to term

You may not qualify if:

• Pregnancies in women previously affected by unclassfied fetal abnormality
• Multiple pregnancy

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

Central Manchester University Hospitals NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

Study Officials

• Ed Johnstone, MBChB PhD MRCOG

  CMFT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 22, 2014
• Study Start: July 1, 2010
• Primary Completion: February 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 4, 2018

Record last verified: 2018-11

Locations

GB (1)