Fetal WeightNCT02396654
5D LB Ultrasound in Determination of Fetal Weight in Normal Pregnancy : A Pilot Study
An observational study of Fetal Weight, run by Ain Shams University at 1 site in Egypt.
Trial summary
5D and 2D ultrasound will be done to normal pregnant women between 37 to 42 weeks gestation and fetal weight will be estimated using the hadlock formula using biometry measured by both ultrasounds. Accuracy of 5D ultrasound in determining fetal weight will be determined. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Weight
- What is being tested?
- 2D and 5D LB ultrasound comparison for fetal weight estimation
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2015to Jan 2016
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Normal pregnant women
Who may be able to join
- 20-40years
- singleton pregnancy
- normal pregnancy
Who cannot join
- Intrauterine fetal death
- multiple pregnancy
- congenital anomaly
- nonvisualized fetal parts by ultrasound
- maternal medical disorders like diabetes and hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Five Dimensional Ultrasound Long Bones Fetal Biometry (5DUS LB ) for Prediction of Fetal Weight Compared to Two Dimensional Ultrasound: a Pilot Study
5D and 2D ultrasound will be done to normal pregnant women between 37 to 42 weeks gestation and fetal weight will be estimated using the hadlock formula using biometry measured by both ultrasounds. Accuracy of 5D ultrasound in determining fetal weight will be determined.
- Conditions
- Fetal Weight
- Being tested
- 2D and 5D LB ultrasound comparison for fetal weight estimation
- Medical subject headings
- Fetal Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D and 5D LB ultrasound comparison for fetal weight estimationOther
2D and 5DUS LB will be done for term pregnant women and fetal weight will be estimated by the hadlock formula. Accuracy of estimated fetal weight by both techniques will be compared to actual birth weight.
| Study group | Role | What they receive |
|---|---|---|
| normal pregnant women | Normal pregnant women between 37 and 42 weeks gestation. Receives: Other: 2D and 5D LB ultrasound comparison for fetal weight estimation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of 5D LB ultrasound in determining fetal weight (estimated by hadlock formula - Accuracy of estimated fetal weight by ultrasound will be compared to actual birth weight)
Measured: 48hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal WeightStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr mohamed laban, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396654
- Sponsor's protocol ID
- m2492
- Status last verified
- Jul 2017
- First submitted
- 19 Mar 2015
- Last updated
- 7 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Five Dimensional Ultrasound Long Bones Fetal Biometry (5DUS LB ) for Prediction of Fetal Weight Compared to Two Dimensional Ultrasound: a Pilot Study
- ClinicalTrials.gov ID
- NCT02396654
- Acronym / sponsor ID
- m2492
- Conditions
- Fetal Weight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 24 Mar 2015 (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.
5D and 2D ultrasound will be done to normal pregnant women between 37 to 42 weeks gestation and fetal weight will be estimated using the hadlock formula using biometry measured by both ultrasounds. Accuracy of 5D ultrasound in determining fetal weight will be determined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| normal pregnant women | – | Other: 2D and 5D LB ultrasound comparison for fetal weight estimationNormal pregnant women between 37 and 42 weeks gestation. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Normal pregnant women
Key inclusion criteria (3 listed)
- 20-40years
- singleton pregnancy
- normal pregnancy
Key exclusion criteria (5 listed)
- Intrauterine fetal death
- multiple pregnancy
- congenital anomaly
- nonvisualized fetal parts by ultrasound
- maternal medical disorders like diabetes and hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2D and 5D LB ultrasound comparison for fetal weight estimation2D and 5DUS LB will be done for term pregnant women and fetal weight will be estimated by the hadlock formula. Accuracy of estimated fetal weight by both techniques will be compared to actual birth weight. | Other | normal pregnant women |
Primary outcome
Accuracy of 5D LB ultrasound in determining fetal weight (estimated by hadlock formula - Accuracy of estimated fetal weight by ultrasound will be compared to actual birth weight)
Time frame: 48hours
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 7 Aug 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Weight, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 5 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 7 Aug 2017. 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 Egypt. 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?
Accuracy of 5D LB ultrasound in determining fetal weight (estimated by hadlock formula - Accuracy of estimated fetal weight by ultrasound will be compared to actual birth weight) (time frame: 48hours). 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 7 Aug 2017.