Fetal DevelopmentNUPSNCT02196363
New Ultrasound Parameters for Predicting Birthweight
An observational study of Fetal Development, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fetal Development
- How many people
- 253 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2010to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- Pregnant women the beginning of pregnancy to term
Who cannot join
- Pregnancies in women previously affected by unclassfied fetal abnormality
- Multiple pregnancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Central Manchester University Hospitals NHS Foundation Trust
Manchester, M13 9WL
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant mothers | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney volume, thigh volume, placental volume, brain volume, final birthweight
Measured: up to 34-36 weeks pregnancy gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startJul 2010
- Primary completionFeb 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ed Johnstone, MBChB PhD MRCOG, Principal investigator, CMFT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196363
- Sponsor's protocol ID
- 10/H1013/9
- Acronym
- NUPS
- Status last verified
- Nov 2018
- First submitted
- 16 Jul 2014
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Ultrasound Parameters for Predicting Birthweight
- ClinicalTrials.gov ID
- NCT02196363
- Acronym / sponsor ID
- NUPS / 10/H1013/9
- Conditions
- Fetal Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- Jul 2010
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 22 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant mothers | – | –No intervention |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Pregnant women the beginning of pregnancy to term
Key exclusion criteria (2 listed)
- Pregnancies in women previously affected by unclassfied fetal abnormality
- Multiple pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Kidney volume, thigh volume, placental volume, brain volume, final birthweight
Time frame: up to 34-36 weeks pregnancy gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ed Johnstone, MBChB PhD MRCOG principal investigator
CMFT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Development, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kidney volume, thigh volume, placental volume, brain volume, final birthweight (time frame: up to 34-36 weeks pregnancy gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2018.